0711_CAPTODAY_ChemistryAnalyzersGuide

美国 CAP的仪器信息介绍

56/ CAP TODAY

July 2011

Chemistry analyzers for mid- and high-volume laboratories Part 1 of 11 MID MID Abbott Diagnostics Pamela Sunderman pamela.sunderman@abbott.com 100 Abbott Park Rd., Abbott Park, IL 60064 847-937-4689 doc.xuehai.net HIGH Abbott Diagnostics Pamela Sunderman pamela.sunderman@abbott.com 100 Abbott Park Rd., Abbott Park, IL 60064 847-937-4689 doc.xuehai.net

Abbott Diagnostics Pamela Sunderman pamela.sunderman@abbott.com 100 Abbott Park Rd., Abbott Park, IL 60064 847-937-4689 doc.xuehai.net ARCHITECT c16000 and ci16200/2007 c16000:$325,000/98; ci16200:$475,000/3 20 (c16000) 474 (i2000SR)/360 (c16000) 5658 (i2000SR) U.S., Japan/U.S., Japan/U.S., Ireland, Germany continuous random access/open reagent system 3-dimensional robotic sample handler and carousel/floor standing c16000: 48× 79× 49/26; ci16200: 48× 127× 49/42 138 (86 clinical chemistry and 52 immunoassay) HIV AgAb combo— vitamin D and vitamin B12 AFP, proGRP, NGAL, anti-HAV IgG, anti-HBc, anti-HBs, HBsAg, HBsAg confirmatory, MPO, SCC, testosterone, CMV IgG, CMV IgG avidity,CMV IgM, rubella IgG, rubella IgM, toxo IgG, toxo IgG avidity, toxo IgM, others— Tg, AFP, anti-HAV IgG, anti-HBc, vitamin D, NGAL, carbamazepine, gentamicin, methotrexate, vitamin B12 photometry, potentiometry (ISE), turbidmetric/ chemiluminescence with flexible protocols (CHEMIFEX) 3 c16000: 68; ci16200: 93 c16000: 220; ci16200: 320 220/220 c16000: 65/50–1,700 (chemistry); ci16200: 93/50–1,700 (chemistry), 100–500 (immunoassay) 7 days/28 days/yes (2°–8°C) yes yes yes c16000:—/215/69,000+; ci16200: varies/365/81,000–93,000 no (chemistry) and yes (immunoassay)/1,200 yes/minimum 1-year guarantee 2µL yes/yes yes/59 L normal operation:≤48 peak; 70 for maximum 10 seconds yes/50µL yes/no yes, on sample transport, shortly before sample is aspirated (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes, 2-D bar codes yes yes yes/yes/yes yes/yes yes yes (for chemistry) yes yes/yes 24 hours/30 days/7 days/14 days no/no 2.6 minutes ISE, 5.9 minutes with CO2; 200 specimens, 800 tests 8.3 minutes, 200 specimens, 1,400 tests 9.8 minutes, 200 specimens, 1,200 tests<20 seconds shortest interval: 8 hours; longest: 24 hours/yes yes/yes yes optional add-on (additional price varies; SW manufacturer: Abbott)/optional, at additional cost Cerner, Misys, Fletcher Flora, Data Innovations, Soft, CPSI, Meditech, Siemens, Citation, CHCS, Antek, Orchard, others yes (broadcast download and host query)— package insert yes yes/yes/yes per negotiated contract 14 weeks (c16000), 11 weeks (i2000SR)/varies daily: 15 minutes; weekly:<45 minutes; monthly: 15 minutes yes/yes 5 days on site, 5 days at vendor offices high-speed integration of CC and IA without compromising stat turnaround time, results, or throughput due to robotic sample handler design and SmartWash technology, which minimizes carryover to<0.1 ppm; large reagent capacity of 93 assays, with sample

load up to 365; CHEMIFEX and FlexRate technologies provide assay extended linearities and enhanced sensitivities

Name of instrument/First year sold in U.S. List price/Total No. sold in 2010 Number of units in clinical use in U.S./Outside U.S. Where designed/Manufactured/Where reagents manufactured Operational type/Reagent type Sample handling system/Model type Dimensions in inches (H× W× D)/Footprint in square feet Number of tests for which analyzer has FDA-cleared applications Tests released for clinical use in last 12 months Tests cleared but not released for clinical use Tests not available in U.S. but submitted for 510(k) clearance Tests not available in U.S. but available in other countries

ARCHITECT c4000 and ci4100/2009 c4000:$180,000; ci4100:$275,000/— 170 (c4000) 382 (i1000sr)/417 (c4000), 2459 (i1000sr) U.S., Japan/U.S., Japan/U.S., Ireland, Germany continuous random access/self-contained multi-use cartridges, open reagent system 3-dimensional robotic sample handler/floor standing c4000: 49× 63× 36/21; ci4100: 49× 111× 36/37 138 (86 clinical chemistry and 52 immunoassay) HIV AgAb combo— vitamin D and vitamin B12 AFP, proGRP, SCC, anti-HAV IgG, CMV IgG and IgM, rubella IgG and IgM, toxo IgG and IgM, CMV avidity, toxo avidity, HCV Ag, pepsinogen I and II, NGAL, kappa light chain, lambda light chain, cholinesterase, cystatin C, and others— anti-HAV IgG, NGAL, methotrexate, Tg, AFP photometry, potentiometry, turbidimetric/ chemiluminescence with flexible protocols 3 c4000: 58; ci4100: 83 c4000: 220; ci4100: 320 220/220 c4000: varies/50–1,700; ci4100: varies/ 50–1,700 chemistry, 100 immunoassay 7 days/28 days/yes (2°–8°C) yes yes yes c4000:—/100/62,000+; ci4100:—/180/64,000+ no (chemistry) and yes (immunoassay)/300 yes, chemistry/minimum 1-year guarantee 2µL yes/no yes/15 L normal operation:≤48; peak: 70 for max 10 seconds yes/50µL yes/no yes, on sample transport, shortly before sample is aspirated (2 of 5 interl., Codabar, codes 39 and 128)/yes yes, 2-D bar codes yes yes yes/yes/yes yes/yes yes yes (for chemistry) yes yes, for chemistry only/yes 24 hours/30 days/7 days/14 days no/no 2.6 minutes ISE, 5.9 minutes with TCO2; 200 specimens, 800 tests 8.3 minutes, 80 specimens, 560 tests 9.8 minutes, 67 specimens, 400 tests<20 seconds shortest interval: 8 hours; longest: 24 hours/yes yes/yes yes yes (additional cost, SW manufacturer: Abbott)/ optional, at additional cost Cerner, Misys, Fletcher Flora, Data Innovations, Soft, CPSI, Meditech, Siemens, Triple G, CIS, others yes (broadcast download and host query)— package insert no yes/yes/yes per negotiated contract 23 weeks (c4000), 26 weeks (i1000sr)/varies daily:<15 minutes; weekly:<35 minutes; monthly:<15 minutes yes/yes yes integration of CC and IA without compromising stat turnaround time, results, or throughput; robotic sample handler design with SmartWash technology allows IA and CC testing in any order for overall turnaround time; fea

tures and benefits standardized across Architect instruments for consistent user experience, reduced variation in operator procedures, fewer errors, and consistent results; large reagent, routine, and stat sample load-up capacity for efficient processing of samples for patient results; refer to the operations manual for operational precautions, limitations, and hazards

ARCHITECT c8000 and ci8200/2003 c8000:$200,000/15; ci8200:$375,000/25 390 (c8000), 474 (i2000sr)/2201 (c8000), 5658 (i2000sr) U.S., Japan/U.S., Japan/U.S., Ireland, Germany continuous random access/self-contained multi-use cartridges, open reagent system 3-dimensional robotic sample handler/floor standing c8000: 48× 79× 49/26; ci8200: 48× 127× 49/42 138 (86 clinical chemistry and 52 immunoassay) HIV AgAb combo— vitamin D and vitamin B12 AFP, proGRP, SCC, anti-HAV IgG, CMV IgG and IgM, rubella IgG and IgM, toxo IgG and IgM, CMV avidity, toxo avidity, HCV Ag, pepsinogen I and II, NGAL, kappa light chain, lambda light chain, cholinesterase, cystatin C, and others— anti-HAV IgG, NGAL, methotrexate, Tg, AFP photometry, potentiometry, turbidimetric/ chemiluminescence with flexible protocols 3 c8000: 68; ci8200: 93 c8000: 220; ci8200: 320 220/220 c8000: 65/50–1,700; ci8200: 90/50–1,170 (chemistry), 100–500 (immunoassay) 7 days/28 days/yes (2°–8°C) yes yes yes c8000:—/215/69,000+; ci8200: varies/365/81,000– 93,000 no (chemistry) and yes (immunoassay)/1,200 yes, chemistry/minimum 1-year guarantee 2µL yes/no yes/30.5 L normal operation:≤48; peak: 70 for maximum 10 seconds yes/50µL yes/no yes, on sample transport, shortly before sample is aspirated (2 of 5 interl., Codabar, codes 39 and 128)/yes yes, 2-D bar codes yes yes yes/yes/yes yes/yes yes yes (for chemistry) yes yes, for chemistry only/yes 24 hours/30 days/7 days/14 days no/no 2.6 minutes ISE, 5.9 minutes with TCO2; 200 specimens, 800 tests 8.3 minutes, 160 specimens, 1,120 tests 9.8 minutes, 133 specimens, 800 tests<20 seconds shortest interval: 8 hours; longest: 24 hours/yes yes/yes yes yes (additional cost, SW manufacturer: Abbott)/ optional, at additional cost Cerner, Misys, Fletcher Flora, Data Innovations, Soft, CPSI, Meditech, Siemens, Triple G, CIS, others yes (broadcast download and host query)— package insert yes yes/yes/yes per negotiated contract 17 weeks (c8000), 11 weeks (i2000sr)/varies daily: 15 minutes; weekly:<45 minutes; monthly: 15 minutes yes/yes yes integration of CC and IA without compromising stat turnaround time, results, or throughput because of the design of the robotic sample handler and SmartWash technology, which minimizes carryover to<0.1 ppm; large reagent capacity of 93 assays, with sample load up to 365; efficiency provided via multiple patented technologies; refer to the operations manual for operational precautions, limitations, and hazards

Research-use-only assays Tests in development Methodologies supported/Immunoassay methodologies Number of direct ion

-selective electrode channels Number of different measured assays onboard simultaneously Number of different assays programmed and calibrated at once Number of user-definable (open) channels/Number active simultaneously Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set Shortest/Median onboard reagent stability/Refrigerated onboard Multiple reagent configurations supported Reagent container placed directly on system for use Instrument has same capabilities when third-party reagents used Walkaway capacity in minutes/Specimens/Tests or assays Uses disposable cuvettes/Maximum number 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 Noise generated in decibels Dedicated pediatric sample cup/Dead volume Primary tube sampling/Pierces caps on primary tubes Sample bar-code reading capability/Autodiscrimination Reagent bar-code reading capability Bar code placement per CLSI standard Auto2A Onboard test auto inventory (determines volume in container) Measures number of tests remaining/Short sample detection/Clot detection Hemolysis/Turbidity detection-quantitation 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/Therapeutic drugs/Drugs of abuse Automatic shutdown programmable/Startup programmable Stat time to completion of all analytes and throughput per hour for: Sodium, potassium, chloride, TCO2 Sodium, potassium, chloride, TCO2, glucose, urea, creatinine Album., direct and total bilirubin, AST, ALT, ALP Typical time delay from ordering stat test to aspiration of sample How often QC required/Onboard SW capability to review QC Onboard real-time QC/Support multiple QC lot numbers per analyte System can automatically transfer QC results to LIS Data management capability/Instrument vendor supplies LIS interface Interfaces to what LISs up and running in active user sites Bidirectional interface capability Uses LOINC to transmit orders and results across interface How labs get LOINC codes for reagent kits Interface available (or will be) to automated specimen-handling system Modem servicing available/System can diagnose own malfunctions/ System can determine malfunctioning component On-site time of service engineer Mean time between failures/Mean time to repair failures Average time to complete maintenance by lab personnel Onboard maintenance records/Maintenance training demo module Training provided with instrument purchase Distinguishing features (provided by vendor)

Note: a dash in lieu of an answer means company did not answer question or question is not applicable

Tabulation does not represent an endorsement by the College of Americ

an Pathologists.

Survey editor: Raymond Aller, MD

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