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Captodayonline.com

1 2 / CAP T O D A Y
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st try analyzers—all that's
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Chemistry meeting: Roche Diagnostics, Car- automatically dilute specimens—meaning, com- Anne Ford
olina Chemistries, and Bayer Diagnostics.
pany president Philip Shugart says, "that re ru n s s more laboratories demand analyzers that
Roche's Cobas 6000 analyzer series, which re- for out-of-range tests, antigen excess checks, can perform both chemistry and im- ceived FDA clearance in March, is designed for et cetera, can be done at the same speed, with- munoassay testing, these hybrid instruments are the mid-volume laboratory and re p re s e n t s out slowing down the instrument." The A & T evolving from what Mark Steelman, Ortho- Roche's second generation of integrated ana- 504X can automatically dilute calibrators as Clinical Diagnostics worldwide product man- lyzers. Roche re p resentative Peter Van Over- well, so that only one calibrator is re q u i red to ager for chemistry systems, calls "bolt-togeth- walle says the company will ultimately off e r run a five-point calibration curve. Shugart adds, er" systems to "integrated systems with fully seven configurations; the first three consist of the "HbA1c on this instrument does not re q u i re a optimized testing and workflow capabilities." Cobas c501 clinical chemistry analyzer, the total hemoglobin for calculating—it is a sin- Jim Schwartz, spokesperson for Abbott Diag- Cobas e 601 immmunoassay analyzer, and the gle-channel test. This feature makes HbA1c nostics, elaborates: "Successful integration goes integrated Cobas 6000 <501 601> analyzer se- testing much easier, faster, and more econom- beyond just hooking the systems together, but ries. The latter offers 88 clini- ical." Also in the works at Car- Survey of chemistry analyzers
rather re q u i res innovative approaches to nu- cal chemistry and immunoas- olina Chemistries are the CAT (for mid- and high-volume labs),
m e rous unique challenges—i.e., maintaining say reagent channels, runs up Workcell (a combination of sample integrity and maximizing workflow to 1,170 tests per hour, fea- and assay performance." t u res a stat interruption mode, and re q u i res 33 A I A 1800 instrument) for chemistry and im- Many of the vendors in this month's instru- s q u a re feet of floor space. All Cobas 6000 in- munochemistry testing and the CAT laborato- mentation survey, which encompasses chemistry s t ruments will offer Cobas Link, which Va n ry automation system, a fully automated plat- and chemistry-immunoassay analyzers for mid- Overwalle calls "one of the most compre h e n s i v e form for handling centrifugation, decapping, to high-volume laboratories, are addre s s i n g connectivity solutions in the market" and which aliquotting, and chemistry and immunochem- these challenges with recently introduced and will offer "screen sharing, remote diagnostics, forthcoming products. Steelman says, "It will and reporting," among other features. To come A t h i rd analyzer scheduled for launch at the take a new generation of analyzers to fully de- in 2008, he adds, is the Cobas 8000 analyzer AACC meeting: Bayer Diagnostics' Advia 1800.
liver on the potential of such [integrated] sys- series, aimed at the high-volume market.
" With a throughput of 1,800 tests per hour, the tems," and while that new generation may not Meanwhile, AACC attendees can also check Advia 1800 is an ideal solution for high-vol- have fully arrived, it appears to be well on its out Carolina Liquid Chemistries' A&T 504X ume automated laboratories in addition to mid- chemistry analyzer. The A&T 504X performs volume stand-alone laboratories," says Eric At CAP TODAY p ress time, at least three com- up to 1,200 tests per hour and eliminates sam- LaFleche, North American associate market- panies aimed to launch new analyzers at this ple pre t reatment of HbA1c by automatically ing manager for clinical chemistry. "The A d v i a month's American Association for Clinical lysing whole-blood samples. In addition, it can 1800, in addition to the Advia 1200 and the A d- and Modern Test Theory, New ciples, is needed. Lip service is utable to a vast improvement of L e t t e r s
York: Holt, Rinehart and Wi n s t o n ; paid frequently to the importance skills of the "failed" cytologists continued from page 1 1 1986). If this fact is disre g a rd e d , of statistics in medical science, during the few weeks that lapsed GK, Collins DN. Acta Cytologica.
then a scientifically sound cytolo- but the use of non-descriptive between the two tests. There is a 1 9 9 1 ;3 5 :3–7). In the 37-year- l o n g gy proficiency test will never be statistics in the practice of ana- far simpler explanation: What we practice of the New York State available. Adjusting the superfi- tomic pathology has generally a re seeing is a statistical phenom- cytology proficiency test, we have cial aspects of the cytology pro f i- remained wishful thinking. Now, enon, known as "re g ression to- seen examples of failures by inter- ciency test, the scoring grids, the when the cytopathology commu- w a rd the mean," which was first nationally known cytopathologists variable validation methods of nity is attempting to introduce a described by Sir Francis Galton in whose expertise was absolutely the slides, and so on, will only highly accurate system in cytolo- 1877. There are two groups of m a rginally improve the test's gy proficiency testing, a consider- examinees who earn failing P roficiency testing is a heavily ation of statistical principles is s c o res during proficiency testing: statistical subject (Crocker L, t h o rough overhaul of the system, m o re important than ever. those whose skills are genuinely Algina J. I n t roduction to Classical based on rational statistical prin- The importance of statistical i n s u fficient and those who are insights for a rational cytology competent but who achieve low p roficiency test can be demon- s c o res due to random variation in strated with an example. Data the test results, as Drs. Hughes, f rom the National Cytology Pro f i- Young, and Wilbur assume. The ciency Testing Update [Cheryl latter "misclassified" examinees Wiseman, MPH, CT(ASCP), of subsequently re g ress toward the CMS, published online Feb. 8, mean during the second test, that 2006] show that as of Jan. 31, is, their test results become more 2006, among 12,786 examinees commensurate with their genuine nine percent failed the test when skills. Since the failure rates of the attempting it for the first time.
participants during the first and For the second attempt, the fail- second attempts are so similar, u re rate—among those who had we have to infer that the majority failed the initial attempt—re- of the failed examinees fall into mained surprisingly similar, 10 the second, misclassified gro u p , p e rcent, though common sense and only a minority have tru l y seems to dictate that the rate i n s u fficient skills. The high fre- should be much higher among quency of misclassification, those who have already failed the which is not only theore t i c a l l y test once and there f o re supposed- fully plausible but also supported ly have lower professional skills.
by Cheryl Wiseman's data, also Yet the passing rate at the second demonstrates that a "short" pro f i- attempt is virtually identical to ciency test based on a small num- the passing rate of all participants ber of test slides has this inhere n t at the first attempt.
weakness—the associated high It would be virtually impossi- misclassification rate. A l o n g ble to conclude that the huge b o a rd-examination type test d e c rease in the failure rate fro m would there f o re be far more 100 percent to 10 percent is attrib- e fficacious in investigating com- Circle No. 45 on reader service card
Please visit us at the AACC, booth #2440
FILE—& PROOF— July Page 1 2
C A P TODAY / 1 3
via 2400, provide the market with a full range chemistry and immunoassay systems to be in- of standardized chemistry platforms." Also at tegrated into a single workcell. "With intelligent AACC, Bayer plans to release a new software sample management and a central data-man- package for its Advia chemistry systems with agement system, the AU-Connector is designed "It's like having three mosquitoes in the back - i m p roved calibration management, simplified to maximize efficiency and throughput while yard and blanketing the entire county with DDT. " user interface, and reagent loading "on the fly" p reserving its flexibility with stat and offline op- —Neil Sandson, MD,
c a p a b i l i t y. "In addition, the software will pro- eration as well as postanalytical sorting to third - on the clinical nonspecificity of all current drugs.
vide customers with improved results re p o r t i n g party and archive racks," A rgentieri says.
("Chip shot—psychiatry puts targeted test in play," page 86)
and archiving capabilities," LaFleche says.
AACC's 2007 meeting may be a year away, Another product intended for introduction at but Ortho-Clinical Diagnostics is already plan- "H ow do we learn from that? Dr. Jones gets sued, the AACC meeting is Olympus America's Olym- ning to introduce its Vi t ros 4,3 FS integrated sys- and then there's this bunch of legal thrashing pus Partner Advantage personal computer tem then. "The system is being designed to in- around fol owed by a confidential settlement. workstation, or OPA. Michael A rgentieri, vice tegrate clinical chemistry and immunodiag- p resident of sales and marketing in the com- nostics in a unique way that intelligently ac- —Elliott Foucar, MD,
pany's diagnostic systems group, says the OPA counts for variable sample and test mixes," on the lack of a systematic collection, analysis,
and distribution of malpractice data by the courts
"combines several key processes, pro g r a m s , Steelman says. "This will allow the system to that could be used to correct flawed medical practices.
and services under one portal through a single p rovide fast and consistent turnaround times in- ("Pathologists given new order in the courtroom," page 5)
workstation" and "enables our customers to continued on page 18 have direct access to our technicall i b r a r y, training and educationalmaterials, third-party QC peer re-view for their Olympus analyzers,technical updates, reagent updates,and service communications andother notices." Olympus A m e r i c adeveloped the OPA after discover-ing through a customer satisfactionsurvey that its clientele wanted tobe able to access the company'sp rograms and services, as well asthose of third parties, through asingle gateway. Olympus will alsodisplay the AU-Connector system,which allows Olympus clinical petence than the federally man-dated short test.
George K. Nagy, MD Wadsworth Center New York State Department of Health A l b a n y In this age of genomics, micro b i- ologists who have been in the pro-fession for many years have to heedand act on the message of the best-selling book Who Moved MyCheese? by Spencer Johnson, MD.
D N A technology is here to stay. Thedramatic and revolutionary shiftf rom phenotypic to genotypic meth-ods was evident at the 2006 meetingof the American Society for Micro b i-o l o g y. Since all areas of the laborato-ry will be forced in the future to dealwith some form of molecular test-ing, analyzing, or reporting or allt h ree, we have found that the besta p p roach is to familiarize ourselveswith basic molecular principlest h rough classes at local colleges. Wecannot blame our employers orc i rcumstances that have forced thechanges that are upon us in this agein which we live and work. We haveto be proactive, and the time to act isn o w.
Arthur P. Guruswamy, BS, SM(ASCP)SLS Jody C. Noe, MS, MT(ASCP)SH Richmond, Va Send letters to Editor, C A P T O D A Y, 325Waukegan Road, Northfield, IL 60093.
Fax: 847-832-8873; s r i c e @ c a p . o r g. Please visit us at the AACC, booth #1443 & 1444
Circle No. 84 on reader service card
FILE—& PROOF— July Page 1 3
1 8 / CAP T O D A Y
C h e m i s t ry analyzers
250 system that features higher throughput and t h rough programmable scheduling of these C h e m i s t ry analyzers
faster time to first result than its pre d e c e s s o r. tasks with material stored refrigerated onboard continued from page 1 3 High-volume laboratories await Dade the analyzer." This year Dade Behring also dependent of sample and test mix." In the mean- Behring's Dimension Vista intelligent laboratory plans to introduce the QCC PowerPak, an "ef- time, the company continues to offer the Vi t ro s system, expected to debut this year. "Dimension ficiency-enhancement package that brings new 5,1 FS chemistry system. Introduced in 2004, the Vista provides the first-time integration of four and exciting features to the Dimension RxL Vi t ros 5,1 FS system was the first instrument to technologies housed within one workstation, re- Max and Dimension Xpand chemistry analyz- o ffer the Vi t ros Micro Tip technology, which al- sulting in the most efficient sample and test ers," says Joseph Meola, MS, MT(ASCP), U.S.
lows users to process assays with disposable tips consolidation available," says Bonita Kushn- marketing manager for automation and Di- and cuvettes, and the first Vi t ros system with erick, director of Vista and field marketing.
mension systems. open-channel capability. In the next few months, Those four technologies—nephelometric, pho- A l ready available from Beckman Coulter: Ortho-Clinical Diagnostics intends to add eight tometric, and the company's proprietary Loci the UniCel DxC 600i integrated workstation, d rugs of abuse, haptoglobin, and homocysteine and V- Lyte multi-sensor technologies—will al- featuring a menu of more than 150 analytes to the menu of the Vi t ros 5,1 FS system; it has al- low users to perform routine and specialty and a throughput of up to 990 chemistry and 100 ready added direct methods for HDL, TIBC, c h e m i s t r y, electrolyte, plasma protein, and im- immunoassay tests per hour. The DxC 600i is the HbA1c, α1-antitrypsin, and antistreptolysin O.
munoassay testing. Kushnerick adds, "Dimen- latest member of the UniCel family of systems, Also available from the company is the Vi t ro s sion Vista will provide hands-off automatic which includes the DxC 600 and DxC 800 chem- 350 chemistry system, a successor to the Vi t ro s p rocessing of calibration and quality contro l istry systems, both launched last year. "It was one of the most successful launch-es for our company," says marketmanager Daniel Siegenthaler. "Weplaced almost 500 systems into themarketplace in the first year." Likeother Beckman Coulter systems,the DxC 600i, DxC 600, and DxC800 feature closed-tube aliquottingand closed-tube sampling. Siegen-thaler says one of the UniCel fam-ily's strengths is its standard i z a-tion of reagents and assays: "Stan-d a rdization seems to be really im-portant, especially here in NorthAmerica where so many purc h a s e sa re made within the group pur-chasing organization or integratedhealth network framework." In 2007, Abbott intends to intro- duce three instruments to its existingA rchitect line: the c16000 chemistrya n a l y z e r, the i1000SR immunoassaya n a l y z e r, and the ci16200 integratedimmunochemistry analyzer. "Wi t hthe launch of these additional A r-chitect analyzers," says Schwartz,"laboratories will be able to achieves t a n d a rdization across entire hos-pital systems with respect to re s u l t s ,operations, and effectiveness." A b-bott already offers the A rc h i t e c tci8200 integrated platform, whichcombines the i2000SR immunoas-say analyzer and c8000 chemistryanalyzer to process up to 200 im-munoassay tests and up to 1,200clinical chemistry tests per hour. TheA rchitect line features robotic sam-ple handling, which, Schwartz says,"integrates immunoassay and clin-ical chemistry testing without com-p romising throughput or assay per-formance for optimized pro d u c t i v-i t y," as well as the SmartWash wash-ing system "for true immunoassayand chemistry testing on one plat-form due to the reduction in carry-o v e r. " CAP TODAY's survey of chem- istry analyzers for mid- and high-volume laboratories includes pro d-ucts from the aforementioned man-u f a c t u rers and from Aw a re n e s sTe c h n o l o g y, Clinical Data, and Ran-dox Laboratories. Vendors suppliedthe information listed. Readers in-t e rested in a particular analyzershould confirm it has the statedf e a t u res and capabilities.
Anne Ford is a writer in Chicago. Circle No. 74 on reader service card
FILE—& PROOF— July Page 1 8
0706_19-26_ChemSvy.qxd 6/30/06 3:19 PM Page 19 C A P TODAY / 1 9
Chemistry analyzers (for mid/high volume laboratories)
Part 1 of 18
100 Abbott Park Rd.
100 Abbott Park Road
Abbott Park, IL 60064
Abbott Park, IL 60064
See related comments, page 14
800-323-9100 w w w . a b b o t t . c o m
800-323-9100 w w w . a b b o t t . c o m
Name of instrument/First year sold in U.S.
Abbott Architect c8000/2003
List price/Total No. sold in 2005
$ 2 2 5 , 0 0 0 / —
$ 3 4 5 , 0 0 0 / —
No. units in clinical use in U.S./Outside U.S.
2 1 0 / 1 , 2 7 0
Country where designed/Manufactured/Where reagents mftd.
U.S., Japan/U.S., Japan/U.S.
Operational type/Reagent type
continuous random access/open reagent system
continuous random access/open reagent system
Sample handling system/Model type
multi-dimensional retest sample handler, carousel/floor standing
rack, carousel/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
48 x 79 x 49/ 26 sq ft
42.7 x 74.4 x 44.1/22.7 sq ft
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
amikacin, quinidine, UIBC, vancomycin, ammonia, ferritin, anti-
amikacin, quinidine, UIBC, vancomycin, ferritin, anti-streptolysin-O,
streptolysin-O, α-1-antitrypsin, α-1-glycoprotein, Lp(a), myoglobin,
α-1-antitrypsin, α-1-glycoprotein, Lp(a), myoglobin, IgE, CRP Vario,
IgE, CRP Vario, β-2-microglobulin, ultra HDL, D-LDL, ecstacy (SQ),
β-2-microglobulin, ultra HDL, D-LDL, ecstacy (SQ), amphet/meth
amphet/meth (SQ), barbiturate (SQ), benzodiazepine (SQ), cannabi-
(SQ), barbiturate (SQ), benzodiazepine (SQ), cannabinoid (SQ),
noid (SQ), cocaine (SQ), ethanol (SQ), methadone (SQ), opiates (SQ),
cocaine (SQ), ethanol (SQ), methadone (SQ), opiates (SQ), cerulo-
Tests cleared but not clinically released
copper, P amylase, CK-MB, enzymatic creatinine
copper, P amylase, CK-MB, enzymatic creatinine
Tests not available in U.S. but submitted for 510(k) clearance
tobramycin, gentamicin, lithium
tobramycin, gentamicin, lithium
Tests not available in U.S. but available in other countries
copper, D-dimer, fructosamine, HBDH, kappa & lambda light chains,
copper, D-dimer, fructosamine, HBDH, kappa & lambda light chains,
Tests in development
acetaminophen, salicylate, tricyclics, barbs-serum, benzo-serum,
acetaminophen, salicylate, tricyclics, barbs-serum, benzo-serum,
PCP (SQ), propoxyphene (SQ)
PCP (SQ), propoxyphene (SQ)
User-defined methods implemented for what analytes
lithium, gentamicin, acetaminophen, salicylate, tobramycin,
lithium, gentamicin, acetaminophen, salicylate, tobramycin,
primidone, tricyclics, LSD, D-dimer
primidone, tricyclics, LSD, D-dimer
Methods supported/immunoassay methods
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
7 days/28 days/yes (2–8°C)
7 days/28 days/yes
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
yes/minimum 1-yr guarantee
yes/minimum 1-yr guarantee
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/50 µL
yes/50 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2 of 5
yes, on sample transport, shortly before sample is aspirated (2 of 5
interl., Codabar, codes 39 & 128)/autodiscrimination
interl., Codabar, codes 39 & 128)/autodiscrimination
Reagent bar-code reading capability
yes, 2-D bar codes
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
8 hr/30 days/14 days/7–14 days
8 hr/30 days/14 days/7–14 days
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
2.5 min, 200 specimens, 800 tests
10 min, 200+ specimens
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
9.6 min, 160 specimens, 1,120 tests
10 min, 200+ specimens
• Album., bili. direct & total, AST, ALT, ALP
9.6 min, 133 specimens, 800 tests
10 min, 200+ specimens
Typical time delay from ordering stat test to aspir. of sample
<20 sec
<15 sec
How often QC required/Onboard SW capability to review QC
shortest interval: 8 hr; longest: 24 hr/yes
shortest interval: 8 hr (ISE); longest: 24 hr/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
yes (addt'l cost, SW mftr: Abbott)
no/yes (addt'l cost)
Interfaces up and running in active user sites with
Cerner, Mysis, Fletcher Flora, Data Innovations, Soft, CPSI,
all major vendors
Meditech, Siemens, Triple G, CIS, others
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
Modem servicing available/Can diagnose own malfunctions/
n o / n o / n o
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: <15 min; weekly: <4 5 min; monthly: 15 min
daily: 5 min; weekly: 1 0 min; monthly: 30 min
Onboard maintenance records/Maint. training demo module
yes (includes audit trail of who replaced parts)/yes
Training provided with purchase/Advanced oper. training avail.
5 days on site, 5 days at vendor offices/yes
5 days on site, 5 days at vendor offices/no
Annual service contract cost (24 h/7 d)
unique multi-dimensional retest sample handler provides excep-
workstation consolidation; high throughput; large capacity;
tional sample management and ensures stat TAT remains constant
reliable; flexible system, extended assay linearity, open channel
regardless of routine workload; large reagent and sample capacity;
test capability, integrated chip technology for ISE (minimum 45,000
liquid ready-to-use reagents; maximizes ease of use with patented
tests per ICT module), auto repeat and auto dilution capability, low
ICT chip; easy-to-use, intuitive software with state-of-the-art
sample volume (2–35 µL)
online operation manuals and troubleshooting
Tabulation does not represent an endorsement by the College of American Pathologists Survey editor: Raymond Aller, MD 0706_19-26_ChemSvy.qxd 6/30/06 3:19 PM Page 22 2 2 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 2 of 18
100 Abbott Park Rd.
100 Abbott Park Rd.
Abbott Park, IL 60064
Abbott Park, IL 60064
See related comments, page 14
Name of instrument/First year sold in U.S.
Abbott Architect ci8200/2003
Abbott Architect c16000/2007
List price/Total No. sold in 2005
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
U.S., Japan/U.S., Japan/U.S.
U.S., Japan/U.S., Japan/U.S.
Operational type/Reagent type
continuous random access/self-contained multi-use cartridges, open
continuous random access/open reagent system
Sample handling system/Model type
multi-dimensional retest sample handler/floor standing
multidimensional robotic sample handler and carousel/floor-standing
Dimensions in inches (H x W x D)/Instrument footprint
48 x 127 x 49/42 sq ft
48 x 79 x 49/26 sq ft
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
amikacin, quinidine, UIBC, vancomycin, ammonia, ferritin, anti-
amikacin, quinidine, UIBC, vancomycin, ammonia, ferritin, anti-
streptolysin-O, α-1-antitrypsin, α-1-glycoprotein, Lp(a), myoglobin,
streptolysin-O, α-1-antitrypsin, α-1-glycoprotein, Lp(a), myoglobin,
IgE, CRP Vario, β-2-microglobulin, ultra HDL, D-LDL, ecstacy (SQ),
IgE, CRP Vario, β-2-microglobulin, ultra HDL, D-LDL, ecstacy (SQ),
amphet/meth (SQ), barbiturate (SQ), benzodiazepine (SQ), cannabi-
amphet/meth (SQ), barbiturate (SQ), benzodiazepine (SQ), cannabi-
noid (SQ), cocaine (SQ), ethanol (SQ), methadone (SQ), opiates (SQ),
noid (SQ), cocaine (SQ), ethanol (SQ), methadone (SQ), opiates (SQ),
Tests cleared but not clinically released
copper, P amylase, CK-MB, enzymatic creatinine
copper, P amylase, CK-MB, enzymatic creatinine
Tests not available in U.S. but submitted for 510(k) clearance
tobramycin, gentamicin, lithium
tobramycin, gentamicin, lithium
Tests not available in U.S. but available in other countries
copper, D-dimer, fructosamine, HBDH, kappa & lambda light chains,
copper, D-dimer, fructosamine, HBDH, kappa & lambda light chains,
Tests in development
acetaminophen, salicylate, tricyclics, barbs-serum, benzo-serum, PCP
acetaminophen, salicylate, tricyclics, barbs-serum, benzo-serum, PCP
(SQ), propoxyphene (SQ)
(SQ), propoxyphene (SQ)
User-defined methods implemented for what analytes
lithium, gentamicin, acetaminophen, salicylate, tobramycin,
lithium, gentamicin, acetaminophen, salicylate, tobramycin,
primidone, tricyclics, LSD, D-dimer
primidone, tricyclics, LSD, D-dimer
Methods supported/immunoassay methods
photometry, potentiometry (ISE), turbidimetric/n/a
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
90/chem 370, immunoassay 100–500
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
144 hr/30 days/yes (2–8°C)
144 hr/28 days/yes (2–8°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
yes, chemistry/minimum 1-yr guarantee
yes/minimum 1-yr guarantee
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
yes/30.5 L
yes/56 µL
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/50 µL
yes/50 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2 of 5
yes, on sample transport, shortly before sample is aspirated (2 of 5
interl., Codabar, codes 39 & 128)/autodiscrimination
interl., Codabar, codes 39 & 128)/yes
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
yes/yes (for chemistry)
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
yes, for chemistry only/yes
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
8 hr/30 days/14 days/7–14 days
8 hr/30 days/14 days/7–13 days
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
2.5 min, 200 specimens, 800 tests
2.5 min, 200 samples
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
9.6 min, 160 specimens, 1,120 tests
9.6 min, 200 samples
• Album., bili. direct & total, AST, ALT, ALP
9.6 min, 133 specimens, 800 tests
9.6 min, 300 samples
Typical time delay from ordering stat test to aspir. of sample
<20 sec
How often QC required/Onboard SW capability to review QC
shortest interval: 8 hr; longest: 24 hr/yes
shortest interval: 8 hr; longest: 24 hr
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
yes (addt'l cost, SW mftr: Abbott)
optional add-on (addt'l—price varies; SW mftr: Abbott)
Interfaces up and running in active user sites with
Cerner, Mysis, Fletcher Flora, Data Innovations, Soft, CPSI, Meditech,
Cerner, Mysis, Fletcher Flora, Data Innovations, Soft, CPSI, Medit ech,
Siemens, Triple G, CIS, others
Siemens, Citation, CHCS, Antec, Orchard, others
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: 23 min; weekly: <45 min; monthly: 15 min
daily: 15 min; weekly: <45 min; monthly: 15 min
Onboard maintenance records/Maint. training demo module
yes (includes audit trail of who rplaced parts)/yes
Training provided with purchase/Advanced oper. training avail.
5 days on site, 5 days at vendor offices/yes
5 days on site, 5 days at vendor office/yes
Annual service contract cost (24 h/7 d)
integration of CC and IA without compromising stat TAT, results, or
<0.1 ppm carryover claim (SmartWash); workstation consolidation; true
throughput because of patented SmartWash technology, which minimizes
integration with immunoassay module; Integrated Chip Technology (ICT);
carryover to <0.1 ppm; large reagent capacity of 93 assays, with sample
FlexRate (extend linearities for enzymatic assays); in-line pressure
load up to 365; efficiency provided via multiple patented technologies
monitoring that detects clots, bubbles, foam, and insufficient sample
volume; reliability; low-sample volume requirements (2–35 µL); automatic
repeat/dilution/reflex protocols; universal sample racks
Tabulation does not represent an endorsement by the College of American Pathologists 0706_19-26_ChemSvy.qxd 6/30/06 3:19 PM Page 24 2 4 / CAP T O D A Y
Chemistry analyzers (for mid/high volume labs)
Part 3 of 18
Abbott Diagnostics
Mike Wright m i c h a e l . w r i g h t @ a b b o t t . c o m
H I G H 100 Abbott Park Rd.
Abbott Park, IL 60064
See related comments, page 14
Name of instrument/First year sold in U.S.
Abbott Architect ci16200/2007
List price/Total No. sold in 2005
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
U.S., Japan/U.S., Japan/U.S.
Operational type/Reagent type
continuous random access/open reagent system
Sample handling system/Model type
multi-dimensional robotic sample handler and carousel/floor-standing
Dimensions in inches (H x W x D)/Instrument footprint
48 x 127 x 49/42 sq. ft
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
IA: DHEA-S, BNP, CA 19-9, anti-HCV, anti-HBs; clinica l chem.: amikacin, quindine, UIBC,
vancomycin, ammonia, ferritin, ASO, α-1-antistrypsin, α-1-glycoprotein, Lp(a),
myoglobin, IgE, CRP Vario, β-2-microglobulin, ultra HDL, D-LDL, ecstasy (SQ),
amphat/meth (SQ), barbs (SQ), benzo (SQ), cannabinoid (SQ), cocaine (SQ), ethanol (SQ),
methadone (SQ), opiates (SQ), ceruloplasmin, cholinesterase
Tests cleared but not clinically released
anti-Tg, AFP, ferrit in, insulin, copper
Tests not available in U.S. but submitted for 510(k) clearance
anti-TPO, SHBG, P. amylase, CK-MB, enzymatic creatinine, tobramycin, gentamicin,
l i t h i u m
Tests not available in U.S. but available in other countries
AFP, anti-HBc, anti-HBc IgM, anti-HBe, anti-HBs, anti-HCV, anti-Tg, anti-TPO, B12,
ferritin, folate, HAVab-IgG, HAVab-IgM, HbsAg, HbsAg confirm, HIV Ag/Ab combo,
insulin, SCC, SHBG, syphilis TP, testosterone, pepsinogen I/II, CMV IgG avidity, cortisol,
PTH; clin chem.: copper, D-dimer, fructosamine, HBDH, kappa/lambda light chains,
digitoxin, gentamicin
Tests in development
MPO, anti-Tg, PTH, TG, SHBG, testosterone, cyclosporine,FK778, sirolimus, tacrolimus,
anti-HBe, core, core-M, HAVAB-G, HAVAB-M, HbeAg , HbsAg, confirm, HIV Ag/AB combo,
rubella IgG, AFP, others
User-defined methods implemented for what analytes
salicylate, tobramycin, primidone, tricyclics, LSD, D-dimer
Methods supported/immunoassay methods
photometry, potentiometry (ISE), turbidmetric chemiluminescence with flexible
protocols (ChemiFlex)
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
93/370 chemistry; 100–500 immunoassay
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
144 hr/30 days/yes (2–8°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
yes/minimum 1-yr guarantee
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/50 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2 of 5 interl, codabar,
codes 39 & 128)/yes
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
yes/yes (for chemistry)
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
8 hr/30 days/14 days/ 7–13 days
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
2.5 min, 200 samples
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
9.6 min, 200 samples
• Album., bili. direct & total, AST, ALT, ALP
9.6 min, 300 samples
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
shortest interval: 8 hr; longest: 24 hr/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
optional add-on (addt'l price varies; SW mftr: Abbott)
Interfaces up and running in active user sites with
Cerner, Mysis, Fletcher Flora, Data Innovations, Soft, CPSI, Meditech, Siemens, Citation,
CHCS, Antec, Orchard, others
Bidirectional interface capability
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: 23 min; weekly: <4 5 min; monthly: 15 min
Onboard maintenance records/Maint. training demo module
yes (includes audit trail of who replaced parts)/yes
Training provided with purchase/Advanced oper. training avail.
5 days on site, 5 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
uniquely multi-dimensional sample handler; <0.1 ppm carryover claim (SmartWash);
large request and sample capacity; IA/CC testing integrated without compromise of stat
TAT; ChemiFlex and FlexRate technologies deliver assay extended linearities and
enhance sensitivities, others
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 27 C A P TODAY / 2 7
Chemistry analyzers (for mid/high volume laboratories)
Part 4 of 18
Awareness Technology Inc.
Bayer Healthcare, Diagnostics Division
P . O . Box 1679
511 Benedict Ave.
Palm City, FL 34991
Tarrytown, NY 10591
See related comments, page 14
772-283-6540 w w w . a w a r e t e c h . c o m
914-333-6130 l a b n e w s . c o m
Name of instrument/First year sold in U.S.
List price/Total No. sold in U.S. in 2005
$ 2 5 , 0 0 0 / —
$ 1 8 9 , 0 0 0 / —
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
Operational type/Reagent type
continuous random access/open ragent system
random access/open reagent system
Sample handling system/Model type
rack of 96 samples/benchtop
Dimensions in inches (H x W x D)/Instrument footprint
19 x 36 x 22 in/7 sq ft
33.5 x 48 x 44 in/1.04 square meters
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
TIBC, ammonia, HbA1C, microalbumin, ASO, ApoA, ApoB, wrCRP,
haptoglobin, IgA, IgG, IgM, carbamazepine, gentamicin, lithiu m,
phenobarb, tobramycin, vancomycin, acetaminophen, ethanol,
salicylate, DAUs, lactate
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
18 EIA kits manuf. by BioCheck have been submitted
Tests not available in U.S. but available in other countries
open system
open system
Tests in development
User-defined methods implemented for what analytes
all colorimetric biochemistry & EIA that read between 340–700 nm
open system architecture, CK-MB, myoglobin, fructosamine, β- 2
microglobulin, D-dimer, caffeine, TCA, Lp(a)
Methods supported/immunoassay methods
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
40 colorimetric, 3 ISE
No. of different assays programmed, calibrated at once
u n l i m i t e d
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
reagent dependent/yes (15°C below ambient) optional
7 days/45 days/yes
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
not limited/96/not limited
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
yes/4 mos
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
no/<1 L
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/50 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, by handheld scanner as tubes are loaded onto instrument (2 or
5 interl., UPC, Codabar, codes 39 & 128)/autodiscrimination
depends on handheld scanner models
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
y e s / y e s / n o
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
user defined for all
daily/30 days/30 days/14 days
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
• Album., bili. direct & total, AST, ALT, ALP
5.5 min, 28 specimens
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
per laboratory protocol/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
onboard/yes (included in price)
Interfaces up and running in active user sites with
not known
Soft, Misys, Cerner, Meditec h, Multidata, Seacoast, Triple G, CCA,
Comp Service & Suppt Q, Fletcher Flora, HDS, PSA Consultants,
Siemens, others
Bidirectional interface capability
yes (broadcast download)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
supplied by reagent manufacturer
Interface avail. (or will be) to automated specimen handling system
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
48 hr/yes
varies by location, generally <4 hr/yes
Mean time between failures/To repair failures
depends on user and varies/depends on problem and varies
Average time to complete maintenance by lab personnel
daily: <5 min; weekly: a bout 15 min; monthly: about 30 min or less
Onboard maintenance records/Maint. training demo module
Training provided with purchase/Advanced oper. training avail.
2 days on site, 3 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
price; one instrument for EIA & biochemistry; completely open and
clot detection; serum indices; 1,200 tests per hour; auto reruns,
user programmable; special discounts for biochemistry only;
dilutions, repeats, reflex testing; open-system for 3rd party assays;
calculates indices; very flexible formatting of reports
part of family of chemistry systems (ADVIA 2400 & ADVIA 1650) and
uses same reagents; short sample detection; liquid level sensing,
refrigerated compartment for calibrators/QC; integration to
C e n t r a l i n k
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 28 2 8 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 5 of 18
Bayer HealthCare, Diagnostics Division
Bayer HealthCare, Diagnostics Division
511 Benedict Ave.
511 Benedict Ave.
Tarrytown, NY 10591
Tarrytown, NY 10591
See related comments, page 14
Name of instrument/First year sold in U.S.
List price/Total No. sold in U.S. in 2005
$ 2 7 9 , 0 0 0 / —
$ 3 0 5 , 0 0 0 / —
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
Operational type/Reagent type
random access/open reagent system
random access/open reagent system
Sample handling system/Model type
carousel rack handler option, automation option/floor standing
carousel, rack handler option, automation optionl/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
45 x 59 x 34/14 sq ft
1,157 x 1,711 x 934 mm/—
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
Tests in development
User-defined methods implemented for what analytes
open system architecture, CK-MB, myoglobin, fructosamine,
open system architecture, CK-MB, myoglobin, fructosamine,
caffeine, TCA, Lp(a), β-2-microglobulin, D-dimer
caffeine, TCA, Lp(a), β-2-microglobulin, D-dimer
Methods supported/immunoassay methods
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
46 colorimetric, 3 ISE
46 colormetric, 3 ISE
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
7 days/45 days/yes
7 days/45 days/yes
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
yes/4 months
yes/every 4 months
Minimum sample volume aspirated precisely at one time
2 µL of diluted specimen
2 µL of diluted specimen
Supplied with UPS (backup power)/Requires floor drain
yes/yes (or sink)
Requires dedicated water system/Water consumption per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/50 µL
yes/ 50 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
daily/30 days/30 days/14 days
daily/30 days/30 days/14 days
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
• Album., bili. direct & total, AST, ALT, ALP
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
per laboratory protocol/yes
per laboratory protocol/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
Interfaces up and running in active user sites with
Soft, Misys, Cerner, Medit ech, Multidata, Seacoast, Triple G, CCA,
Dawning, Paradox LIS, PerSé, Data Innovations, Misys, Soft, Cerner,
Comp Service & Suppt Q, Fletcher Flora, HDS, PSA Consultants,
C i t a t i o n
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
via software
Interface avail. (or will be) to automated specimen handling system
yes (all systems)
yes (with ADVIA WorkCell as of October 2003)
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
varies by location, generally <4 hr/yes
varies by location, generally <4 hr/yes
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
automated daily maintenance
automated daily maintenance
Onboard maintenance records/Maint. training demo module
Training provided with purchase/Advanced oper. training avail.
Annual service contract cost (24 h/7 d)
system will aspirate every three seconds and retain aliquot
system provides true workstation consolidation with more than 80
onboard; original sample is available to leave system; all testing
available chemistry and special chemistry methods and applica-
performed with aliquot of sample remaining on ADVIA 1650; all
tions; also offers user-defined methods that equate to cost-
reruns/repeats/ dilutions automatically performed without operator
effective consolidation; offers unrivaled walkaway capability with
intervention; microvolume technology allows up to 840 tests from a
an onboard capacity of >450 specimens with the Universal Rack
70-mL test wedge of reagent; reflex testing available; 98 percent
Handler option; 32,000 photometric tests and 90,000 ISE tests;
sample saver technology allows automatic repeats, dilutions and
reflex testing without operator intervention of having to return to
the original specimen
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 30 3 0 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 6 of 18
Beckman Coulter Inc.
Beckman Coulter Inc.
200 South Kraemer Blvd.
P . O . Box 8000
200 South Kraemer Blvd., P.O. Box 8000
Brea, CA 92822-8000
Brea, CA 92822-8000
See related comments, page 14
Name of instrument/First year sold in U.S.
S y n c h r o n CX9 Pro/2001
UniCel DxC 600/2004
List price/Total No. sold in U.S. in 2005
No. units in clinical use in U.S./Outside U.S.
> 1 , 0 0 0 / > 6 0 0
> 2 5 0 / > 1 0 0
Country where designed/Manufactured/Where reagents mftd.
U.S./U.S./U.S. & Ireland
U.S./U.S./U.S. & Ireland
Operational type/Reagent type
continuous random access/open reagent system
continuous random access/open reagent system
Sample handling system/Model type
sectors, centrifugable/floor standing
racks, centrifugable/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
69 x 74 x 30 in/15.4 sq ft
62 x 62 x 41 in/17.7 sq ft
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
Tests in development
sirolimus, tacrolimus, tricyclics, semiquantitative drugs of abuse
sirolimus, tacrolimus, tricyclics, semi-quantitative drugs of abuse
User-defined methods implemented for what analytes
UIBC, cyclosporine, homocysteine
UIBC, cyclosporine, homocysteine
Methods supported/immunoassay methods
photometry, potentiometry, turbidimetric/bidentate turbidimetric, direct
photometry, potentiometry, near-infrared bidentate turbidimetric/
turbidimetric, particle enhanced turbidimetric, enzyme immunoassay
particle enhanced turbidimetric, enzyme immunoassay, near infrared
particle immunoassay
No. of direct ion selective electrode channels
5 (indirect)
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
3 3 / 2 5 – 2 , 5 0 0
65/about 3,500 modular; about 600 cartridge
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
168 hr/30 days/yes (2–8°C)
168 hr/30 days/yes (2–8°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
yes/permanent–2-yr warranty (80 stored on instrument)
yes/2-yr warranty, semi-permanent
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/40 µL
yes/40 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2 of 5
yes, on sample transport, shortly before sample is aspirated (2 of 5
interl., Codabar, codes 39 & 128)/autodiscrimination
interl., Codabar, codes 39 & 128)/autodiscrimination
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
24 hr/up to 90 days/up to 60 days/14 days
1 day/up to 90 days/up to 60 days/14 days
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
52 sec, 75 specimens
6:15 from standby, 96 specimens
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
52 sec, 75 specimens
6:15 from standby, 96 specimens
• Album., bili. direct & total, AST, ALT, ALP
10 min, 32 specimens
13:07 from standby, 57 specimens
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
24 hr/yes
24 hr/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
onboard & optional add-on (SW mftr: Beckman Coulter)/yes (addt'l
onboard & optional add-on (SW mftr: Beckman Coulter)/yes (addt'l
Interfaces up and running in active user sites with
Cerner, Misys, Meditech, Citation, MedLab, CHC, Siemens,
Cerner, Misys, Meditech, Citation, MedLab, CHC, Siemens,
McKesson, Labquest, CCA, VA-Mumps, all LISs
McKesson, Labquest, CCA, VA-Mumps
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
yes (Power Processor)
yes (Beckman Coulter automation)
Modem servicing available/Can diagnose own malfunctions/
y e s / n o / n o
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
metro: same day, rural: same or next day/yes
metro: same day, rural: same or next day/yes
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: 5 min; weekly: 15 min; monthly: 25 min
daily: none; weekly: 7 min (tech time); monthly: 11 min (tech time)
Onboard maintenance records/Maint. training demo module
yes (includes audit trail of who replaced parts)/yes
Training provided with purchase/Advanced oper. training avail.
5 days at vendor offices/yes
5 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
serum indices; centrifugable sectors; clot detection; design
closed-tube sampling; serum indices/polychromatic correction;
optimized for automation; continuous random access for samples,
clot detection and correction; centrifugable racks, no-wait
controls, reagents, and results; no-maintenance glucose oxygen
autoloader; calibration data provided on disk; Peltier ring with
sensor; no-wait autoloader; polychromatic correction; thermal ring
semi-permanent glass cuvettes; pulsed Xenon lamp; intuitive
and semipermanent glass cuvettes; pulsed xenon lamp; advanced
operator software; DL2000: stat notification, review by exception,
workflow and results mgmt.; liquid, rea dy-to-use reagents,
reflex testing, add-on test notification
calibrators, controls; DL2000 Workflow and Results Manager
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 32 3 2 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 7 of 18
Beckman Coulter Inc.
Beckman Coulter Inc.
200 South Kraemer Blvd.
P . O . Box 8000
P . O . Box 8000
Brea, CA 92822-8000
Brea, CA 92822-8000
See related comments, page 14
Name of instrument/First year sold in U.S.
Unicel DxC 600i/2006
List price/Total No. sold in U.S. in 2005
No. units in clinical use in U.S./Outside U.S.
> 8 0 0 / > 3 0 0
Country where designed/Manufactured/Where reagents mftd.
U.S./U.S./U.S. & Ireland
Operational type/Reagent type
continuous random access/open reagent system
continuous random access/open reagent system
Sample handling system/Model type
racks, centrifugable/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
62 x 126.5 x 48/42.16
LX20 60 x 70 x 41/19.9 sq ft; LX4201 60 x 140 x 41/39.8 sq ft
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
intrinsic factor Ab
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
DHEA-S, TPO Ab, iPTH
Tests not available in U.S. but available in other countries
IL-6, TPO Ab, EPO, iPTH
Tests in development
EPO, ANA Screen, ds D NA Ab, β-2-glycoprotein 1 Ab, CMV IgG, CMV
sirolimus, tacrolimus, tricyclics, semiquantitative drugs of abuse
IgM, rubella IgM, Inhibin A, PIGF (pre-eclampsia), SVEGFRI (pre-
eclampsia) BPH-A, [-2]proPSA, soluble transferrin receptor
User-defined methods implemented for what analytes
UIBC, cyclosporine, homocysteine
UIBC, cyclosporine, homocysteine
Methods supported/immunoassay methods
photometry, potentiometry (ISE), turbidimetric, enzyme
photometry, potentiometry, near infrared/bidentate turbidimetric, direct
turbidimetric, particle enhanced turbidimetric, enzyme immunoassay
No. of direct ion selective electrode channels
5 (indirect)
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
89/about 300 cartridge (chem), 50 per pack (immuno)
4 1 / 1 0 , 6 5 0
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
168 hr/28 days/yes (2–10°C)
168 hr/30 days/yes (2–8°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
yes/2-yr warranty (chem)
yes/semi-permanent—2-yr warranty (250 stored on instrument)
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/40 µL (samples directly from pediatric bullet)
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2 of 5
yes, on sample transport, shortly before sample is aspirated (2 of 5
interl, Codabar, codes 39 & 128)/yes
interl., Codabar, codes 39 & 128)/autodiscrimination
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
1 day/90 days/up to 60 days/14 days
24 hr/up to 90 days/up to 60 days/14 days
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
8:15 from standby, 96 specimens
38 sec, 90 specimens
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
8:15 from standby, 96 specimens
38 sec, 90 specimens
• Album., bili. direct & total, AST, ALT, ALP
15:07 from standby, 57 specimens
8 min, 90 specimens
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
24 hr/—
24 hr/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
onboard & optional add-on (sw mftr: Beckman Coulter)
onboard & optional add-on (Beckman Coulter DL2000)/yes (addt'l
c o s t )
Interfaces up and running in active user sites with
Cerner, Misys, Meditech, Citation, MedLab, CHC, Siemens,
Cerner, Misys, Meditech, Citation, MedLab, CHC, Siemens,
McKesson, Labquest, CCA, VA-Mum ps
McKesson, Labquest, CCA, VA-Mum ps, all LISs
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
yes (Power Processor, total lab automation)
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
metro: same day; rural: same day or next
metro: same day, rural: same or next day/yes
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: <15 min, weekly: 3 6 min; monthly: 11 min
daily: none; weekly: 5 min; monthly: 25 min
Onboard maintenance records/Maint. training demo module
yes (includes audit trail of who replaced parts)/no
Training provided with purchase/Advanced oper. training avail.
10 days at vendor offices/yes
5 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
closed-tube aliquot and closed-tube sampling reduce manual
serum indices; centrifugable racks; clot detection; no-wait
processes and improve safety; parallel processing of chemistry and
autoloader/linear racks; multiple wavelength blanking; smart
immunoassay helps eliminate bottle necks; one of the broadest
modules, fiber optics; advanced workflow and data management;
menus available on a single workstation; consolidation of chem-
thermal ring and semipermanent glass cuvettes; pulsed xenon
istry and immunoassay without compromise
lamp; electronic stat notification; review by exception; reflex
testing; add-on test, DL2000 Workflow and Results Manager
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 34 3 4 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 8 of 18
Beckman Coulter Inc.
Beckman Coulter Inc.
200 South Kraemer Blvd.
P . O . Box 8000
200 South Kraemer Blvd.
Brea, CA 92822-8000
P.O. Box 8000
Brea, CA 92822
See related comments, page 14
Name of instrument/First year sold in U.S.
S y n c h r o n LX20 Pro/2001
List price/Total No. sold in U.S. in 2005
$ 3 4 3 , 0 0 0 / —
No. units in clinical use in U.S./Outside U.S.
> 8 0 0 / > 3 0 0
> 4 0 0 / > 2 5 0
Country where designed/Manufactured/Where reagents mftd.
U.S./U.S./U.S. & Ireland
Operational type/Reagent type
continuous random access/open reagent system
continuous random access/open reagent system
Sample handling system/Model type
racks, centrifugable/floor standing
racks, centrifugable/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
60 x 70 x 41/19.9 sq ft
60 x 134.5 x 48/44.8 sq ft
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
Tests in development
sirolimus, tacrolimus, tricyclics, semiquantitative drugs of abuse
intact PTH, EPO, IL-6, dsDNA, TNF-α, soluble transferrin receptor,
β-2-gylcoprotein 1 Ab
User-defined methods implemented for what analytes
UIBC, cyclosporine, homocysteine
UIBC, homocysteine, cyclosporine
Methods supported/immunoassay methods
photometry, potentiometry, near infrared-bidentate turbidimetric,
photometry, potentiometry (ISE), near infrared-bidentate turbidi-
direct turbidimetric, particle enhanced turbidimetric/enzyme
metric, direct turbidimetric, particle enhanced turbidimetric/en-
immunoassay, near infrared particle immunoassay
zyme immunoassay, chemiluminescence
No. of direct ion selective electrode channels
5 (indirect)
5 (indirect)
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
4 1 / 1 0 , 6 5 0
6 5 / 1 1 , 8 5 0
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
168 hr/30 days/yes (2–8°C)
168 hr/28 days/yes (2–10°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
yes/semi-permanent—2-yr warranty (250 stored on instrument)
yes/2-yr (chemistry) warranty, semi-permanent
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/40 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2 of 5
yes, on sample transport, shortly before sample is aspirated (2 of 5
interl., Codabar, codes 39 & 128)/autodiscrimination
interl., Codabar, codes 39 & 128)/autodiscrimination
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
yes (chemistry)/yes (chemistry)
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
yes (chemistry)/yes (chemistry)
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
1 day/up to 90 days/up to 60 days/14 days
24 hr/up to 90 days/up to 60 days/14 days
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
38 sec, 90 specimens
38 sec, 90 specimens
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
38 sec, 90 specimens
38 sec, 90 specimens
• Album., bili. direct & total, AST, ALT, ALP
8 min, 90 specimens
8 min, 90 specimens
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
24 hr/yes
24 hr/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
onboard & optional add-on (Beckman Coulter DL2000)/
onboard & optional add-on (Beckman Coulter)/
yes (addt'l cost)
yes (addt'l cost)
Interfaces up and running in active user sites with
Cerner, Misys, Meditech, Citation, MedLab, CHC, Siemens,
McKesson, Labquest, CCA, VA-Mum ps, all LISs
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
yes (Power Processor, total lab automation)
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
metro: same day, rural: same or next day/yes
metro: same day, rural: same or next day/yes
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: none; weekly: 5 min; monthly: 25 min
daily: 15 min; weekly: 33.5 min; monthly: 25 min
Onboard maintenance records/Maint. training demo module
Training provided with purchase/Advanced oper. training avail.
5 days at vendor offices/yes
10 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
serum indices; centrifugable racks; clot detection; no-wait
workstation consolidation without compromise through single
autoloader/linear racks; multiple wavelength blanking; smart
point of sample entry for both chemistry and immunoassay testing;
modules, fiber optics; advanced workflow & data management;
closed- tube sampling; one of fastest stats for chemistry samples;
thermal ring and semipermanent glass cuvettes; pulsed xenon
dual scheduling and parallel processing of chemistry and im-
lamp; electronic stat notification; review by exception; reflex
munoassay samples for optimum throughput; menu equivalence to
testing; add-on test; closed-tube sampling, near infrared detection
Synchron and Access product lines
(for high-sensitivity CRP), DL2000 Workflow and Results Manager
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 35 C A P TODAY / 3 5
Chemistry analyzers (for mid/high volume laboratories)
Part 9 of 18
Beckman Coulter Inc.
Carolina Liquid Chemistries
Patricia A. Shugart [email protected]
200 South Kraemer Blvd.
510 W. Central Ave.
P.O. Box 8000
Brea, CA 92823
Brea, CA 92822
See related comments, page 14
Name of instrument/First year sold in U.S.
UniCel DxC 800/2005
List price/Total No. sold in U.S. in 2005
No. units in clinical use in U.S./Outside U.S.
> 1 5 0 / > 2 0 0
Country where designed/Manufactured/Where reagents mftd.
U.S./U.S./U.S. & Ireland
Operational type/Reagent type
continuous random access/open reagent system
continuous random access/self-contained single-use
cartridges-packages-slides
Sample handling system/Model type
racks, centrifugable/floor standing
rack, ring/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
62 x 70 x 41/19.9 sq ft
50 x 47.2 x 34.5/—
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
80 different assays—contact company for listing
Tests in development
sirolimus, tacrolimus, tricyclics, semi-quantitative drugs of abuse
80 different assays—contact company for listing
User-defined methods implemented for what analytes
UIBC, cyclosporine, homocysteine
Methods supported/immunoassay methods
photometry, potentiometry (ISE), near-infrared bidentate turbidimetric,
direct turbidimetric, particle enhanced turbidimetric/enzyme
immunoassay, near infrared particle immunoassay
No. of direct ion selective electrode channels
3 (Na, K+, and Cl-)
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
70/approx. 3,500 (modular); 600 cartridge
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
168 hr/30 days/yes (2–8°C)
720 hr/30 days/yes (6-10°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
yes/2-yr warranty, semi-permanent
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/40 µL (samples directly from bullet)
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2 of 5
yes, on sample transport, shortly before sample is aspirated (2
interl., Codabar, codes 39 & 128)/autodiscrimination
of 5 interl., Codabar, codes 39 & 128)/yes
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
1 day/up to 90 days/up to 60 days/14 days
24 hr/2 weeks/—/—
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
2:23 (from standby), 91 specimens
10 min, 1,200
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
2:22 (from standby), 91 specimens
10 min, 1,200
• Album., bili. direct & total, AST, ALT, ALP
12:32 (from standby), 76 specimens
10 min, 1,200
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
24 hr/yes
shortest interval: 8 hr; longest: 24 hr/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
onboard & optional add-on (Beckman Coulter)/yes (addt'l cost)
onboard/yes (addt'l cost; SW mftr: A&T)
Interfaces up and running in active user sites with
Cerner, Misys, Meditech, Citation, Medlab, CHC, Siemens,
McKesson, Labquest, CCA, VA-Mumps
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
yes, Beckman Coulter automation
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
metro: same day, rural: same or next day/yes
24 hr/yes
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: none; weekly: 10 min (tech time); monthly: 18 min (tech time)
daily: 10 min; weekly: 10 min; monthly: 10 min
Onboard maintenance records/Maint. training demo module
yes (includes audit trail of who replaced parts/yes
Training provided with purchase/Advanced oper. training avail.
5 days at vendor offices/yes
5 days on site, 4 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
closed-tube sampling; serum indices/polychromatic correction;
onboard automatic rerun using internal sample dilution cup;
clot detection & correction; centrifugable racks; no-wait
ready to connect with any laboratory automation system; small
autoloader; calibration data provided on disk; Peltier ring with
semi-permanent glass cuvettes; pulsed Xenon lamp; intuitive
operator software; one of the fastest stat TAT; DL2000: stat
notification, review by excep tion, reflex testing, add-on test
n o t i f i c a t i o n
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 36 3 6 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 10 of 18
2 Thurber Blvd.
2 Thurber Blvd.
Smithfield, RI 02917
Smithfield, RI 02917
See related comments, page 14
Name of instrument/First year sold in U.S.
Vitalab Selectra XL/2004
List price/Total No. sold in U.S. in 2005
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
Operational type/Reagent type
random access/multi-use bottles
random access/self-contained multi-use cartridges, packages, slides
Sample handling system/Model type
Dimensions in inches (H x W x D)/Instrument footprint
45 x 46 x 30/12 sq ft
24 x 22 x 39/—
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
Tests in development
User-defined methods implemented for what analytes
Methods supported/immunoassay methods
photometry, potentiometry (ISE)/—
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
72 hr/7 days/yes (12°C below ambient)
40 hr/10 days/yes (12–15°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
yes/every 10,000 reactions
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/20 µL
yes/50 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, as sample is being aspirated (2 of 5 interl., UPC, Codabar,
yes, as sample is being aspirated
codes 39 & 128)
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
4 hr/1–14 days/—/—
4 hr/7 days/n/a/n/a
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
8 min, —
2 min 20 sec, 240
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
10 min, —
7 min 30 sec, 47
• Album., bili. direct & total, AST, ALT, ALP
10 min, —
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
shortest interval: 4 hr; longest: once a day/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
optional add on/yes
no/yes (addt'l cost)
Interfaces up and running in active user sites with
Antek, Labdaq, Fletcher-Flora, Labpak
Bidirectional interface capability
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
within 24 hr/yes
24 hr/yes
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: 10 min; weekly: 20 min; monthly: 60 min
daily: 5 min; weekly: 15 min; monthly: 30 min
Onboard maintenance records/Maint. training demo module
Training provided with purchase/Advanced oper. training avail.
3 days on site/yes
5 days on site
Annual service contract cost (24 h/7 d)
4 parameter dry ISE with CO ; reusable reaction cuvette rotor;
4 parameter dry ISE with CO ; 570 tests per hour benchtop;
onboard wash system
onboard touch screen LCD monitor
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 38 3 8 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 11 of 18
Dade Behring Inc.
Dade Behring Inc.
1717 Deerfield Rd.
1717 Deerfield Rd.
Deerfield, IL 60015
Deerfield, IL 60015
See related comments, page 14
Name of instrument/First year sold in U.S.
Dimension RxL Max Integrated Chemistry System/2003
Dimension Vista 1500/2006
List price/Total No. sold in U.S. in 2005
No. units in clinical use in U.S./Outside U.S.
RxL: 2,500/—; RxL Max: >600/—
Country where designed/Manufactured/Where reagents mftd.
U.S./U.S./U.S. and Germany
Operational type/Reagent type
batch, random access, continuous random access/self-
batch, random access, continuous random access/self-
Sample handling system/Model type
segmented sample wheel/floor standing
sample rack and aloquot plate system/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
44 x 62.5 x 30.5/13.2 sq ft
55 x 84 x 43/26 sq ft
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
Tests cleared but not clinically released
CSA extended range
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
Tests in development
MPA, sirolimus, tacrolimus, ecstasy
User-defined methods implemented for what analytes
propoxyphene, methaqualone, serum tricyclic antidepressant,
serum barbiturate, serum benzodiazepine
Methods supported/immunoassay methods
photometry, potentiometry, Integrated Multisensor Technology
photometry, potentiometry (ISE), advanced LOCI chemilumines-
(IMT)/heterogenous EIA using HM, EMIT latex particle turbidi-
cence technology, nephelometry, EMIT PETINIA PETIA ACMIA LOCI,
metric, latex turbidimetric
No. of direct ion selective electrode channels
3 (indirect) ECO2 photometric
No. of different measured assays onboard simultaneously
44/88 with optional inventory management system
up to 100 methods simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
—/up to 100 methods simultaneously
No. of different analytes for which system accommodates
44–88/max. 360
100/20-1,200 tests, flex
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
72 hr/30 days/yes (2–8°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
can be hours
System is liquid or dry
liquid, reconstitutes onboard
Uses disposable cuvettes/Max. No. stored
yes/>1,500 washed, disposable cuvettes and 1,000 LOCI vessels
Uses washable cuvettes/Replacement frequency
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
yes/3.2 L
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
no/20 µL
Primary tube sampling/Pierces caps on primary tubes
yes, 5, 7, 10 mL/no
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2
yes, on sample transport, shortly before sample is aspirated (2
of 5 interl., Codabar, codes 39 & 128)/autodiscrimination
of 5 interl., Codabar, codes 39 & 128)/yes
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
yes (with 7.4 software)
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
every 2 hr-autocalibrate/—/60–90 days/30 days
automatic every 4 hr/30-90 days/30 days/30 days
no/no (2 min tech time, 5 min instrument time)
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
50 sec, 288 tests
2 min, 166
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
4.5 min, 500 tests
4–7 min, 166
• Album., bili. direct & total, AST, ALT, ALP
10–11 min, 500 tests
<15 min, 200
Typical time delay from ordering stat test to aspir. of sample
<2 min
How often QC required/Onboard SW capability to review QC
24 hr/yes
shortest: 24 hr; longest: user defined/yes, via EasyLink
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
yes, via EasyLink
Data mgmt. capability/Instrument vendor supplies LIS interface
optional add-on (DBNet, Dade Behring)/yes (addt'l cost)
onboard (Dade Behring)/—
Interfaces up and running in active user sites with
all major LIS vendors
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
yes, Dade Behring StreamLab, SpecTrak
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
2–8 hr/yes
2–8 hr/yes
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: 5 min; weekly: 10 min; monthly: 15 min
daily: none; weekly: none; monthly: 10–20 min
Onboard maintenance records/Maint. training demo module
Training provided with purchase/Advanced oper. training avail.
5 days on site, 4 days at vendor offices/yes
5 days on site, 5 days at vendor office/yes (online training available)
Annual service contract cost (24 h/7 d)
integrates heterogenous immunoassays onboard with other
ultra-integration using 4 detection systems with new LOCI and
chemistries; allows single platform for over 95 percent of most
nephelometry; automatic QC and calibration with refrigerated
requested tests; eliminates sample splitting between general
onboard materials; proactive service system
tests and immunoassays
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 40 4 0 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 12 of 18
Olympus America Inc.
Olympus America Inc.
3500 Corporate Parkway
3500 Corporate Parkway
Center Valley, PA 18034
Center Valley, PA 18034
See related comments, page 14
Name of instrument/First year sold in U.S.
List price/Total No. sold in U.S. in 2005
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
Japan/Japan/U.S. & Ireland
Japan/Japan/U.S. & Ireland
Operational type/Reagent type
random access, discrete, continuous random access/open
random access, discrete, continuous random access/open
Sample handling system/Model type
rack & stat carousel/floor standing
rack & stat carousel/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
47.6 x 57.1 x 29.9/62.7 sq ft
50 x 74 x 32/68 sq ft
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
Tests in development
User-defined methods implemented for what analytes
fructosamine, ammonia, oxycodone
fructosamine, ammonia, oxycodone
Methods supported/immunoassay methods
photometry, potentiometry, calculated tests/homogeneous
photometry, potentiometry, calculated tests/homogeneous
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
48 x 2/100–1,333
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
120 hr/30 days/yes (4–12˚C)
120 hr/30 days/yes (4–12°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
varies/up to 102/varies
varies/up to 172/varies
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
no (optional)/yes (no w/ optional water pump)
no (optional)/yes (no w/ optional water pump)
Requires dedicated water system/Water consumption per hour
yes/26 L per hr peak consumption
yes/40 L per hr peak consumption
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2
yes, on sample transport, shortly before sample is aspirated (2
of 5 interl., Codabar, codes 39 & 128)/autodiscrimination
of 5 interl., Codabar, codes 39 & 128)/autodiscrimination
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
1 day/30 days/14 days/14–20 days
1 day/30 days/14 days/14–20 days
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
<5 min, 200 specimens
<4 min, 200 specimens
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
<5 min, 80 specimens
<5 min, 160 specimens
• Album., bili. direct & total, AST, ALT, ALP
<9 min, 67 specimens
9 min, 133 specimens
Typical time delay from ordering stat test to aspir. of sample
<2 min
How often QC required/Onboard SW capability to review QC
per CLIA & laboratory's decision/yes
per CLIA & laboratory's decision/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
Interfaces up and running in active user sites with
all common interfaces including Cerner, Antrim, CCA,
all common interfaces including Cerner, Antrim, CCA,
Chemware, Dawning Technol., ADAC, Dynamic Healthcare,
Chemware, Dawning Technol., ADAC, Dynamic Healthcare,
Antek, Siemens, McKesson (Data Innov.), CPSI, Meditech, Misys,
Antek, Siemens, McKesson (Data Innov.), CPSI, Meditech, Misys,
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
Mean time between failures/To repair failures
average 2 calls per yr/<24 hr
average 2 calls per yr/<24 hr
Average time to complete maintenance by lab personnel
daily: 3 min; weekly: 7 min; monthly: 45 min
daily: 3 min; weekly: 27 min; monthly: 45 min
Onboard maintenance records/Maint. training demo module
yes (includes audit trail of who replaced parts)/yes
yes (includes audit trail of who replaced parts)/yes
Training provided with purchase/Advanced oper. training avail.
3–5 days on site, 5 days at vendor offices/yes
3–5 days on site, 5 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
Olympus SUPPORTVISION, an Internet-based, real-time
Olympus SUPPORTVISION, an Internet-based, real-time
monitoring system for proactive services; standardization with
monitoring system for proactive services; standardization with
family of chemistry immuno systems, the AU400, AU400e,
its family of chemistry immuno systems, the AU400, AU400e,
AU600, AU640, AU640e, AU2700, and AU5400; broad test menu
AU600, AU640, AU640e, AU2700, and AU5400; broad test menu
of 125 methods delivers standardized results for improved
of 125 methods delivers standardized results for improved
patient management and streamlined operation
patient management and streamlined operation
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 42 4 2 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 13 of 18
Olympus America Inc.
Olympus America Inc.
3500 Corporate Parkway
3500 Corporate Parkway
Center Valley, PA 18034
Center Valley, PA 18034
See related comments, page 14
Name of instrument/First year sold in U.S.
AU5421 with dual ISE/2001
List price/Total No. sold in U.S. in 2005
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
Japan/Japan/U.S. & Ireland
Japan/Japan/U.S. & Ireland
Operational type/Reagent type
random access, discrete, continuous random access/open
random access, discrete, continuous random access/open
Sample handling system/Model type
rack & stat carousel/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
50 x 79 x 45/92 sq ft
50 x 148 x 45/46.25 sq ft
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
Tests in development
User-defined methods implemented for what analytes
fructosamine, ammonia, oxycodone
fructosamine, ammonia, oxycodone
Methods supported/immunoassay methods
photometry, potentiometry, calculated tests/homogeneous
photometry, potentiometry, calculated tests/homogeneous
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
48 x 2/100–4,000
48 x 4/100–4,000
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
120 hr/30 days/yes (4–12°C)
120 hr/30 days/yes (4–12°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
varies/up to 322/varies
varies/up to 300/varies
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
yes/65 L per hr peak consumption
yes/120 L
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2
yes, on sample transport, shortly before sample is aspirated (2
of 5 interl., Codabar, codes 39 & 128)/autodiscrimination
of 5 interl.)/autodiscrimination
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
1 day/30 days/14 days/14–20 days
1 day/30 days/14 days/14–20 days
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
<4 min, 267 specimens
—, max 600
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
<4 min, 267 specimens
—, max 600
• Album., bili. direct & total, AST, ALT, ALP
9 min, 267 specimens
—, max 533
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
per CLIA & laboratory's decision/yes
per CLIA & laboratory's decision/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
Interfaces up and running in active user sites with
all common interfaces including Cerner, Antrim, CCA, Chemware,
all common interfaces including Cerner, Antrim, CCA, Chemware,
Dawning Technol., ADAC, Dynamic Healthcare, Antek, Siemens,
Dawning Technol., ADAC, Dynamic Healthcare, Antek, Siemens,
McKesson (Data Innov.), CPSI, Meditech, Misys, Citation, SCC
McKesson (Data Innov.), CPSI, Meditech, Misys, Citation, SCC
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: 5 min; weekly: 30 min; monthly: 45 min
daily: 5 min; weekly: 30 min; monthly: 45 min
Onboard maintenance records/Maint. training demo module
yes (includes audit trail of who replaced parts)/yes
yes (includes audit trail of who replaced parts)/yes
Training provided with purchase/Advanced oper. training avail.
3–5 days on site, 5 days at vendor offices/yes
5 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
Olympus SUPPORTVISION, an Internet-based, real-time
Olympus SUPPORTVISION, an Internet-based, real-time
monitoring system for proactive services; standardization with
monitoring system for proactive services; standardization with
its family of chemistry immuno systems—the AU400, AU400e,
its family of chemistry immuno systems—the AU400, AU400e,
AU600, AU640, AU640e, AU2700, and AU5400; broad test menu
AU600, AU640, AU640e, AU2700, and AU5400; broad test menu
of 125 methods delivers standardized results for improved
of 125 methods delivers standardized results for improved
patient management and streamlined operation
patient management and streamlined operation
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 44 4 4 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 14 of 18
Olympus America Inc.
3500 Corporate Parkway
Center Valley, PA 18034
1001 U.S. Highway 202
Raritan, NJ 08869
See related comments, page 14
Name of instrument/First year sold in U.S.
AU5431 with dual ISE/2001
List price/Total No. sold in U.S. in 2005
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
Japan/Japan/U.S. & Ireland
Operational type/Reagent type
random access, discrete, continuous random access/open
batch, random access, discrete, continuous random
access/self-contained single-use cartridges, packages, slides
Sample handling system/Model type
Dimensions in inches (H x W x D)/Instrument footprint
50 x 200 x 45/62.5 sq ft
47 x 45.5 x 28/8.8 sq ft
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
Tests in development
User-defined methods implemented for what analytes
fructosamine, ammonia, oxycodone
Methods supported/immunoassay methods
photometry, potentiometry, calculated tests/homogeneous
potentiometry, colorimetric, rate, immuno-rate/—
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
48 x 6/100–4,000
up to 60/18, 50, 60
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
120 hr/30 days/yes (4–12°C)
48 hr/14 days/no
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
varies/up to 300/varies
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
available (not included)/no
Requires dedicated water system/Water consumption per hour
yes/180 L
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
no special sample cup required/35 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2
yes, on sample transport, shortly before sample is aspirated (2
of 5 interl., Codabar, codes 39 & 128)/autodiscrimination
of 5 interl., Codabar, codes 39 & 128)/autodiscrimination
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
not needed/not needed
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
1 day/30 days/14 days/14–20 days
reagent lot changes
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
—, max 600
6 min, 240
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
—, max 600
6 min 24 sec, 287
• Album., bili. direct & total, AST, ALT, ALP
—, max 800
6 min 40 sec, 261
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
per CLIA & laboratory's decision/yes
24 hr/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
Interfaces up and running in active user sites with
all common interfaces including Cerner, Antrim, CCA, Chemware,
Dawning Technol., ADAC, Dynamic Healthcare, Antek, Siemens,
McKesson (Data Innov.), CPSI, Meditech, Misys, Citation, SCC
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: 5 min; weekly: 30 min; monthly: 45 min
daily: 2 min; weekly: 5 min; monthly: 15 min
Onboard maintenance records/Maint. training demo module
yes (includes audit trail of who replaced parts)/yes
Training provided with purchase/Advanced oper. training avail.
5 days at vendor offices/yes
3 days on site, 5 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
Olympus SUPPORTVISION, an Internet-based, real-time
cost-effective MicroSlide Technology delivers low cost per
monitoring system for proactive services; standardization with
reportable result and high reagent efficiency without the costs,
its family of chemistry immuno systems—the AU400, AU400e,
maintenance, preparation, carryover, and interference associated
AU600, AU640, AU640e, AU2700, and AU5400; broad test menu
with traditional water-based and indirect ISE systems; QC
of 125 methods delivers standardized results for improved
procedures are required just once each day and calibration
patient management and streamlined operation
intervals up to six months with minimal interferences from
hemolysis, lipemia; no plumbing, drains, vents, or deionized water
required; all waste is contained in used test slides that are
disposed of daily
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 46 4 6 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 15 of 18
1001 U.S. Highway 202
1001 U.S. Highway 202
Raritan, NJ 08869
Raritan, NJ 08869
See related comments, page 14
Name of instrument/First year sold in U.S.
VITROS 950, VITROS 950AT/1995
VITROS 250, VITROS 250AT/1993
List price/Total No. sold in U.S. in 2005
950: $196,000; 950 AT: $250,000
250 $105,000; 250 AT $165,000
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
Operational type/Reagent type
batch, random access, discrete, continuous random
batch, random access, discrete, continuous random
Sample handling system/Model type
sample trays/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
55 x 68 x 38/26 sq ft
47 x 45.5 x 28/8.8 sq ft
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
Tests in development
User-defined methods implemented for what analytes
Methods supported/immunoassay methods
potentiometry, colorimetric, rate, immuno-rate/—
potentiometry, colorimetric, rate, immuno-rate/—
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
up to 75/up to 60
up to 60/up to 60
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
48 hr/14 days/no
48 hr/14 days/no
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
available (not included)/no
available (not included)/no
Requires dedicated water system/Water consumption per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
no special sample cup required/35 µL
no special sample cup required/35 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2
yes, on sample transport, shortly before sample is aspirated (2
of 5 interl., Codabar, codes 39 & 128)/autodiscrimination
of 5 interl., Codabar, codes 39 & 128)/autodiscrimination
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
not needed/not needed
not needed/not needed
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
reagent lot changes
reagent lot changes
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
6 min, 600
6 min, 240
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
6 min, 700
7 min, 258
• Album., bili. direct & total, AST, ALT, ALP
7 min, 700
7 min 17 sec, 230
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
24 hr/yes
24 hr/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
Interfaces up and running in active user sites with
all common interfaces
all common interfaces
Bidirectional interface capability
yes (broadcast download)
yes (broadcast download)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
yes (enGen)
yes (enGen)
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
<4 hr/yes
<4 hr/yes
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: 2 min; weekly: 5 min; monthly: 15 min
daily: 2 min; weekly: 5 min; monthly: 15 min
Onboard maintenance records/Maint. training demo module
Training provided with purchase/Advanced oper. training avail.
3 days on site, 5 days at vendor offices/yes
3 days on site, 5 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
cost-effective MicroSlide Technology delivers low cost per
cost-effective MicroSlide Technology delivers low cost per
reportable result and high reagent efficiency without the costs,
reportable result and high reagent efficiency without the costs,
maintenance, preparation, carryover, and interference
maintenance, preparation, carryover, and interference
associated with traditional water-based and indirect ISE sys-
associated with traditional water-based and indirect ISE
tems; QC procedures are required just once each day and
systems; QC procedures are required just once each day and
calibration intervals up to six months with minimal
calibration intervals up to six months with minimal
interferences from hemolysis, lipemia; no plumbing, drains,
interferences from hemolysis, lipemia; no plumbing, drains,
vents, or deionized water required; all waste is contained in
vents, or deionized water required; all waste is contained in
used test slides that are disposed of daily
used test slides that are disposed of daily
Tabulation does not represent an endorsement by the College of American Pathologists 0706_27-48_ChemSvyAwar-Randox.qxd 7/5/06 1:29 PM Page 48 4 8 / CAP T O D A Y
Chemistry analyzers (for mid/high volume laboratories)
Part 16 of 18
Randox Laboratories Ltd
H I G H Mia Ares-Borcky
1001 U.S. Highway 202
4065 Oceanside Blvd., Ste. Q
Raritan, NJ 08869
Oceanside, CA 92056
See related comments, page 14
Name of instrument/First year sold in U.S.
VITROS 5,1 FS Chemistry System/2004
List price/Total No. sold in U.S. in 2005
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
Operational type/Reagent type
random access, discrete, continuous random access/
self-contained single-use cartridges-packages-slides;
user-defined assay capability
Sample handling system/Model type
universal sample tray/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
52.5 x 92.2 x 33.4/21.4 sq ft
23 x 38 x 28/3.1 x 2.3
No. of tests for which analyzer has FDA-cleared applications
62 diff analytes/91 diff cat
Tests clinically released in last 12 months
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
acetic acid, Apo E, Apo CIII, Apo CII, Apo AII, α-1-antitrypsin, α- 1 -
acid glycoprotein, bile acids, butyryl cholinesterase, enzymatic chlo-
ride, glutamate dehydrogenase, glutathione reductase, haptoglobin,
HBDH, leucine arylamidase, L-lactate, L-lactic acid, malic acid, total
antioxidant status, β-hydroxybutyrate, glutathione peroxidase, glyc-
erol, NEFA, superoxide dismutase, zinc
Tests in development
opiates, PCP, cocaine, barbiturate, benzodiazapine, cannabinoid,
User-defined methods implemented for what analytes
acetaminophen, drugs of abuse, salicylate, cyclosporine, alcohol,
glycerol-3-phosphate, oxidase, phospholipids, maltose, T4, T-uptake
Methods supported/immunoassay methods
photometry, potentiometry, immuno-rate, turbidimetric, colori-
photometry, potentiometry (ISE)/immunoturbidimetric, latex
No. of direct ion selective electrode channels
3 (direct)
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
up to 125/up to 100
3 7 / 7 1 – 1 , 0 5 3
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
48 hr/14 days/yes (temp: 10°C)
8 hr/28 days/yes (8–12°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
dry, liquid ready to use
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
available (not included)/no
Requires dedicated water system/Water consumption per hour
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
no special sample cup required/35 µL
yes/20 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated
yes, on sample transport, shortly before sample is aspirated
(2 of 5 interl., Codabar, codes 39 & 128)/autodiscrimination
(2 of 5 interl, UPC, Codabar, codes 39 &128)/yes
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
y e s / y e s / n o
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
reagent lot changes
daily/28 days/7 days/n/a
no/no (instrument maintained in ready mode)
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
5.5 min, 400
2 min (not including TC02—non ISE), 240
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
5.75 min, 625
11 min 55 sec, 560
• Album., bili. direct & total, AST, ALT, ALP
7.5 min, 360
12 min 15 sec, 400
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
once per 24 hr/yes
shortest interval: daily; longest: customer's discretion
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
onboard (optional add-on)/no
o n b o a r d / n o
Interfaces up and running in active user sites with
all major LIS vendors
Bidirectional interface capability
yes (broadcast download & host query)
yes (host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
yes (enGen, plus any open point in space systems)
Modem servicing available/Can diagnose own malfunctions/
n o / y e s / y e s
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
<4 hr/yes
within 24 hr
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
daily: 9 min; weekly: 5 min; monthly: 31 min
daily 5 min; weekly: 15 min; monthly: —
Onboard maintenance records/Maint. training demo module
Training provided with purchase/Advanced oper. training avail.
3 days on site/yes
Annual service contract cost (24 h/7 d)
cost-effective MicroSlide Technology delivers low cost per reportable
bench top analyzer offering more methods than most other
result and high reagent efficiency without the costs, maintenance,
analyzers in its class; multi-speed mixers allowing optimum
preparation, carryover, and interference associated with traditional
mixing for each assay; comprehensive QC software providing
water-based and indirect ISE systems; QC required just once each day
unrivaled confidence in results
and calibration intervals up to lot change with min. interferences from
hemolysis, lipemia; no plumbing, drains, vents, or deionized water
required; all waste is contained in used test slides or disposable
cuvette; eConnectivity interactive management system onboard
Tabulation does not represent an endorsement by the College of American Pathologists 0706_51-58_ChemSvyRoche.qxd 7/5/06 9:50 AM Page 51 C A P TODAY / 5 1
Chemistry analyzers (for mid/high volume laboratories)
Part 17 of 18
Todd Atkinson, Product Manager
Lisa Hunter Ryden, Product Manager
9115 Hague Rd., P.O. Box 50457
9115 Hague Rd.
Indianapolis, IN 46250
Indianapolis, IN 46250
See related comments, page 14
800-428-5074 ext. 14011 us.labsystems.roche.com
Name of instrument/First year sold in U.S.
Cobas Integra 800/2001 (Integra introduced 1995)
Integrated Modular Analytics/2002
List price/Total No. sold in 2005
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
multiple countries/multiple countries/multiple countries
Operational type/Reagent type
random access, discrete, continuous random access/self-
continuous random access/self-contained, multi-use cartridges-
Sample handling system/Model type
sample racks: RD 5-position rack/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
47.3 x 74.8 x 35.4/—
varies with configuration/varies with configuration
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
LDL, CRP WR, UIBC
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
LDH (P➝L), ALP (DGKC), AT3, CHE-D, GLDH, HBDH, lipoprotein(a),
kappa, lambda, apo A, apo B, Lp(a), osteocalcin, P1NP
kappa/lambda light chains
Tests in development
MPA, sirolimus, tacrolimus
ACTH, PAPP-A, vitamin D3, P1NP, anti-CMV IgG, anti-CMV IgM, anti-TSH
receptor, homocysteine, mycophenolic acid, tacrolimus, protease
inhibitors, hepatitis A, hepatitis B, HIV combi, rubella IgG & IgM, toxo IgG
& IgM, IL-6, sCD40 ligand, CA 72-4 (gastric), cyfra 21-1/NSE (lung), NSE
User-defined methods implemented for what analytes
yes, varies
yes, varies
Methods supported/immunoassay methods
photometry, potentiometry, fluorescence polarization/
photometry, potentiometry (ion selective electrode)/electrochemilu-
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
336 hr/84 days/yes (8°C)
72 hr/90 days/yes (2–12˚C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
yes, 1,000 tests
Uses washable cuvettes/Replacement frequency
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
no (direct connection, type I NCCLS)/5–7 L
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/approx. 50–70 µL
yes/50 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes (2 of 5 interl., Codabar, codes 39 & 128)/autodiscrimination
yes, on sample transport, shortly before sample is aspirated (2 of 5
interl., Codabar, codes 39 & 128)/autodiscrimination
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
5 hr/once per lot/140 days/60 days
24 hr/varies from bottle change to lot change/bottle change/—
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
8.6 min, 118 specimens
3.5 min, 300–600 specimens
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
8.6 min, 99 specimens
5.5 min, 160–600 specimens
• Album., bili. direct & total, AST, ALT, ALP
9.8, 118 specimens
10 min, 133–600 specimens
Typical time delay from ordering stat test to aspir. of sample
How often QC required/Onboard SW capability to review QC
typically once per 24 hr/yes
24 hr/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
onboard/yes (addt'l cost)
onboard/no (addt'l cost)
Interfaces up and running in active user sites with
Cerner, CHCS, Citation, Compton, CompuLab, DynaMedix, EDS,
all major LIS vendors
Fletcher Flora, McKesson (ALG, PathLabs, StarLabs), HMS, Intellilabs,
Isys, LabDaq, Labforce, Labfusion, LabSoft, LCI, Meditech, Northern
Soft, Orsys, Seacoast, Siemens, Soft Computer, Misys
Bidirectional interface capability
yes (broadcast download & host query)
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
yes (Roche Pre-Analytical Modular)
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
8 hr or next business day/yes
Mean time between failures/To repair failures
260 days/3.5 hr
Average time to complete maintenance by lab personnel
daily: <1 min; weekly: <5 min; monthly: none
daily: 5 min hands-on; weekly: 30 min; monthly: 15 min
Onboard maintenance records/Maint. training demo module
yes (includes audit trail of who replaced parts)/yes (onscreen
yes (includes audit trail of who replaced parts)/yes
help with diagrams & maintenance wizard)
Training provided with purchase/Advanced oper. training avail.
1 day on site, 5 days at vendor offices/yes
5 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
comprehensive test menu including hemoglobin A1c; reagent cas-
high-throughput clinical chemistry and immunoassay system with
sette requires no operator prep. or special handling (can go straight
single point of entry; single user interface; single host connection,
from refrigerator to system with no warmup time); 97 percent of
providing productivity & efficiency gains; system offers flexibility to
reagents are liquid, ready to use, system automatically reconstitutes
easily expand configuration on site; enhanced intelligent process
if necessary, system forecasts daily reagent requirements based on
management achieves optimized sample routing, seamless integra-
history; operator maintenance automatically scheduled by system,
tion of stat samples into routine workflow, automatic rerun and
based on actual use, not by calendar schedule; 800 has clot detec-
repeat testing selectable by test and real-time reflex testing with
tion, bubble detection, and can accommodate universal five-position
Roche rack for modular systems and Elecsys IA a n a l y z e r s
Tabulation does not represent an endorsement by the College of American Pathologists 0706_51-58_ChemSvyRoche.qxd 7/5/06 9:50 AM Page 55 C A P TODAY / 5 5
Chemistry analyzers (for mid/high volume labs)
Part 18 of 18
Roche Diagnostics
Lisa Hunter Ryden, Product Manager
9115 Hague Rd.
Indianapolis, IN 46250
800-428-5074 ext. 14011
See related comments, page 14
Name of instrument/First year sold in U.S.
List price/Total No. sold in 2005
No. units in clinical use in U.S./Outside U.S.
Country where designed/Manufactured/Where reagents mftd.
multiple countries/multiple countries/multiple countries
Operational type/Reagent type
continuous random access/self-contained multiuse cartridges-packages-slides
Sample handling system/Model type
5-position rack/floor standing
Dimensions in inches (H x W x D)/Instrument footprint
varies per configuration/varies
No. of tests for which analyzer has FDA-cleared applications
Tests clinically released in last 12 months
LDL, CRP WR, UIBC
Tests cleared but not clinically released
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries
Lp(a), kappa, lambda, P/NP, TG
Tests in development
ACTH, PAPP-A, vitamin D3, P1NP, anti-CMV IgG, anti-CMV IgM, anti-TSH receptor,
homocysteine, mycophenolic acid, tacrolimus, protease inhibitors, hepatitis A, hepati-
tis B, HIV combi, rubella IgG & IgM, toxo IgG & IgM, IL-6, sCD40 ligand,
CA 72-4 (gastric), cyfra 21-1/NSE (lung), NSE
User-defined methods implemented for what analytes
yes, varies
Methods supported/immunoassay methods
No. of direct ion selective electrode channels
No. of different measured assays onboard simultaneously
No. of different assays programmed, calibrated at once
No. of user-definable (open) channels/No. active simultaneously
No. of different analytes for which system accommodates
reag. containers onboard at once/Tests per container set
Shortest/median onboard reag. stability/Refrigerated onboard
72 hr/28 days/yes (2–12°C)
Multiple reag. configurations supported
Reag. container placed directly on system for use
Instrument has same capabilities when 3rd-party reag. used
Walkaway capacity in minutes/Specimens/Tests-assays
System is liquid or dry
Uses disposable cuvettes/Max. No. stored
Uses washable cuvettes/Replacement frequency
Minimum sample volume aspirated precisely at one time
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption per hour
yes/varies (50 L/hr/mod)
Noise generated in decibels
Dedicated pediatric sample cup/Dead volume
yes/50 µL
Primary tube sampling/Pierces caps on primary tubes
Sample bar-code reading capability
yes, on sample transport, shortly before sample is aspirated (2 of 5 interl., Codabar,
codes 39 & 128)/autodiscrimination
Reagent bar-code reading capability
Bar code placement per CLSI standard Auto2A
Onboard test auto inventory (determines volume in container)
Measures no. tests remaining/Short sample detection/Clot detection
Automatic detection of adequate reag. for aspir. & analysis
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be reduced/Increased to rerun out-of-linear-
range high/low results
Autocalibration or autocalibration alert
Calibrants stored onboard/Multipoint calibration supported
Typical calib. frequency for ISE/Metabolites/Ther. drugs/Drugs of abuse
24 hr/varies/bottle change/lot change
Stat time to completion of all analytes, throughput per hr. for:
• Sodium, potassium, chloride, TCO2
3.5 min, 300–600 specimens
• Sodium, potassium, chloride, TCO2, glucose, urea, creatinine
5.5 min, 160–600 specimens
• Album., bili. direct & total, AST, ALT, ALP
10.5 min, 133–1,200 specimens
Typical time delay from ordering stat test to aspir. of sample
<1 min
How often QC required/Onboard SW capability to review QC
24 hr/yes
Onboard real-time QC/Support multiple QC lot Nos. per analyte
QC results transferred automatically to LIS
Data mgmt. capability/Instrument vendor supplies LIS interface
Interfaces up and running in active user sites with
all major LIS vendors
Bidirectional interface capability
yes (broadcast download & host query)
Test results transmitted to LIS as soon as chem. time complete
LIS interface operates simultaneously with running assays
Uses LOINC to transmit orders & results
How labs get LOINC codes for reagent kits
Interface avail. (or will be) to automated specimen handling system
yes (Roche Pre-Analytical Modular)
Modem servicing available/Can diagnose own malfunctions/
Determine malfunctioning component
On-site time of svc. engineer/Onboard error codes for troubleshooting
Mean time between failures/To repair failures
260 days/3.5 hr
Average time to complete maintenance by lab personnel
daily: 5 min; weekly: 10 min; monthly: 15 min
Onboard maintenance records/Maint. training demo module
yes (includes audit trail of who replaced parts)/yes
Training provided with purchase/Advanced oper. training avail.
5 days at vendor offices/yes
Annual service contract cost (24 h/7 d)
Roche Hitachi chemistry and automation proven reliability and more than 20
years of experience; capable of consolidating 95 percent of test menu on one
high-throughput Integrated Modular System; system can be connected directly to
preanalytical automation with 12 modules per configuration; flexible, expandable
to lab's changing needs; up to four modules per system
Tabulation does not represent an endorsement by the College of American Pathologists

11-18 4.pdf

Source: http://www.captodayonline.com/Archives/surveys/0706ChemSvy.pdf