automated immunoassay analyzers

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1 38 CAP TODAY JUNE 2017 Part 1 of 21 Abbott Diagnostics Abbott Diagnostics Abbott Diagnostics 100 Abbott Park Rd., CP Abbott Park Rd., CP Abbott Park Rd., CP1-4 Abbott Park, IL Abbott Park, IL Abbott Park, IL Name of instrument/first year sold/where designed ARCHITECT i1000sr/2008/u.s. ARCHITECT i2000sr/2002, i4000sr/2007/u.s. ARCHITECT ci4100 (2009), ci8200 (2003), ci16200 (2007)/U.S. Country where manufactured/where reagents manufactured Singapore/U.S., Europe Singapore/U.S., Europe Singapore (IA), Japan (chemistry)/u.s., Europe Number of units in clinical use in U.S./Outside U.S. Operational type/model type/sample handling system continuous random access/floor standing/robotic sample handler allows batch, random access, continuous access, and reagent loading and unloading batch, random access, continuous random access/ floor standing/track and LAS Dimensions in inches (H W D)/Instrument footprint in sq. feet / /20.7 (i2000sr) /43.2 Tests not available in U.S. but available in other countries Tests in development Tests not available on other manufacturers Fully automated microplate system Number of each analyte performed in separate disposable unit Methods supported/separation methods chemiluminescence/magnetic particle Chemiflex (enhanced chemiluminescence) with 5 flexible protocols/magnetic microparticle batch, random access, continuous random access/floor standing/robotic sample handler uses multidimensional sample handling photometric, potentiometric, and Chemiflex (enhanced chemiluminescence)/ Number of different measured assays onboard simultaneously , based on analyzer Number of different assays programmed, calibrated at once assays available Number of user-definable (open) channels none none 220 (on chemistry modules only) Number of different analytes for which system accommodates reagent 25/100 25/100 tests and 500 tests per kit 93/61 1,700 Shortest/Median onboard reagent stability/refrigerated onboard 14 days (vitamin D)/30 days tracked in hours/yes 14 days (vitamin D)/30 days tracked in hours/yes CC: 5 days/28 days/yes; IA: 14 days (vitamin D)/30 days tracked in hours/yes Reagents barcoded/information in barcode yes/assay number, reagent serial number, lot number, tests per kit, expiration, onboard stability time, others yes/assay No., reagent serial No., lot No., tests per kit, exp. date, onboard stability time, master calibration curve yes/assay name, reagent number, lot number, tests per kit, expiration date, others Same capabilities when 3rd-party reagents used/susceptibility to carryover no/<0.1 ppm no/<0.1 ppm yes (chemistry)/<0.1 ppm Walkaway capacity in minutes/specimens/tests, assays 180/65/25 300/135/12, /367/>75,000 System is open (homebrew methods can be used)/liquid or dry system no/liquid no/liquid yes (chemistry)/liquid Uses disposable cuvettes/maximum number stored yes/360 yes/1,200 disposable and semipermanent/see individual standalone modules Uses washable cuvettes/replacement frequency no/ no/ yes/as needed, minimum 1-year guarantee Minimum specimen volume required varies based on assay varies based on assay varies based on assay Minimum sample volume aspirated precisely at once/minimum dead volume 10 µl/50 µl 10 µl/50 µl 2 µl (chemistry), 10 µl (IA)/50 µl Supplied with UPS (backup power)/requires floor drain yes/no yes/no yes/yes Requires dedicated water system/water consumption no/ no/ yes/25 L per hour (ci8200); 52 L per hour (ci16200); 15 L per hour (ci4100) Noise generated 58 decibels during normal operation, 62 decibels maximum decibels decibels Has dedicated pediatric sample cup/dead volume no/ no/ no/ Primary tube sampling/tube sizes/pierces caps on primary tubes yes/5-, 7-,10-mL tubes and sample cups/no yes/5-, 7-,10-mL tubes and sample cups/no yes/5-, 7-, 10-mL tubes and sample cups/no Sample barcode reading capability/autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes Barcode placement per CLSI standard Auto2A yes yes yes Clot detection/reflex testing capability yes/yes yes/yes yes/yes Hemolysis detection-quantitation/turbidity detection-quantitation no/no no/no yes/yes Dilution of patient samples onboard/automatic rerun capability yes/yes yes/yes yes/yes Sample volume can be reduced to rerun out-of-linear range high results/ no/no no/no no/no Time between initial result and reaspiration of sample for rerun Autocalibration or autocalibration alert yes yes yes Number of calibrators required for each analyte 2 6, assay dependent 2 6, assay dependent 2 6, assay dependent Calibrants can be stored onboard/average calibration frequency no/calibration required with new lot no/calibration required with new lot IA: no/calibration with new lot; CC: no/28 days Multipoint calib. supported/multiple calibs. stored for same assay yes/yes (up to 4 curves per analyte) yes/yes (up to 4 curves per analyte) yes/yes (up to 4 curves per analyte) How often QC required every 24 hours or per lab-specific procedure every 24 hours or per lab-specific procedure every 24 hours or per lab-specific procedure Automatic shutdown/startup is programmable/startup time no/no/6.5 minutes /no/10 minutes /no/10 minutes Stat time to completion of βhcg test 18 minutes 18 minutes 18 minutes Time delay from ordering stat test to aspiration of sample Throughput per hour for three analytes on each specimen, in number of up to 33 samples/100 tests per hour up to 67 samples/200 tests per hour up to 267/800 (c4000); 400/1200 (c8000); 600/1800 (c16000); 33/100 (i1000sr); 67/200 (i2000sr) Data-management capability/instrument vendor supplies LIS interface onboard/no onboard/no onboard/no LIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendors Bidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query) Interface available (or will be) to auto specimen handling system yes yes no yes/yes/yes yes/yes/yes yes/yes/yes Can order (via modem) malfunctioning part(s) without operator yes yes, AbbottLink yes, AbbottLink On-site response time of service engineer Mean time between failures/to repair failures Average time to complete maintenance by lab personnel Onboard maintenance records/maintenance training demo module yes/yes yes/yes yes/yes List price/targeted bed size or daily volume Training provided with purchase/advanced operator training yes/yes yes/yes yes/yes streamlined workload management; continuous access to reagents, samples, and supplies; 65-sample load capacity; 13 universal bays, 7 customizable priority bays; refrigerated reagent carousel with test-kit sizes; reagents stable onboard up to 30 days; priority tests; 18-minute turnaround time on stat assays Chemiflex technology delivers excellent sensitivities and extended linearities; RSH allows priority and routine samples to be processed simultaneously without compromising stats; refer to operations manual for operational precautions, limitations, and hazards; class 1 laser product integration of CC and IA without compromising stat turnaround time, results, or throughput because of patented SmartWash technology, which minimizes carryover to <0.1 ppm; reagent capacity of 93 assays, with sample load up to 367; refer to operations manual for operational precautions, limitations, and hazards

2 JUNE 2017 CAP TODAY 39 Part 2 of 21 Alere Alere Alere Beata Blyskal beata.blyskal@alere.com Beata Blyskal beata.blyskal@alere.com Beata Blyskal beata.blyskal@alere.com 2 Research Way, Princeton, NJ Research Way, Princeton, NJ Research Way, Princeton, NJ Name of instrument/first year sold/where designed Agility/2012/U.S. DS2/2007/U.S. DSX/2004/U.S. Country where manufactured/where reagents manufactured U.S./worldwide U.S./worldwide U.S./worldwide Number of units in clinical use in U.S./Outside U.S. 50/50 800/1,500 1,200/1,800 Operational type/model type/sample handling system batch/benchtop/rack batch/benchtop/rack batch/benchtop/rack Dimensions in inches (H W D)/Instrument footprint in sq. feet / / /7 open system, tests provided by various manufacturers open system, tests provided by various manufacturers open system, tests provided by various manufacturers Tests not available in U.S. but available in other countries Tests in development Tests not available on other manufacturers Fully automated microplate system yes yes yes Number of each analyte performed in separate disposable unit 1 per well 1 per well 1 per well Number of wells in microplate 96 (minimum: 1 strip; maximum: 12 full plates) 96 (minimum: 1; maximum: 96) 96 (minimum: 1; maximum: 96) Methods supported/separation methods enzyme immunoassay/coated microplate wells enzyme immunoassay/coated microwell enzyme immunoassay/coated microwell Number of different measured assays onboard simultaneously 16 assay dependent (24 control positions) assay dependent (33 control positions) Number of different assays programmed, calibrated at once 12 assay dependent (24 control positions) assay dependent (33 control positions) Number of user-definable (open) channels unlimited unlimited unlimited Number of different analytes for which system accommodates reagent 16/96 assay dependent (18 reagent positions)/96 assay dependent (24 reagent positions)/96 Shortest/Median onboard reagent stability/refrigerated onboard / /no / /no / /no Reagent container placed directly on system for use yes yes, 2 ml control vials (other reagents are pour off) yes, 2 ml control vials (other reagents are pour off) Reagents barcoded/information in barcode yes/lot information no/ no/ Same capabilities when 3rd-party reagents used/susceptibility to carryover yes/none, uses disposable tips yes/none, uses disposable tips yes/none, uses disposable tips Walkaway capacity in minutes/specimens/tests, assays assay dependent/200+ continuous load/12+ continuous load assay dependent/100/assay dependent assay dependent/98/assay dependent System is open (homebrew methods can be used)/liquid or dry system yes/liquid yes/liquid yes/liquid Uses disposable cuvettes/maximum number stored no/ no/ no/ Uses washable cuvettes/replacement frequency no/ no/ no/ Minimum specimen volume required 10 µl 10 µl 10 µl Minimum sample volume aspirated precisely at once/minimum dead volume 10 µl/150 µl 10 µl/50 µl 5 µl/50 µl Supplied with UPS (backup power)/requires floor drain yes/no yes/no yes/no Requires dedicated water system/water consumption no/ no/ no/ Noise generated Has dedicated pediatric sample cup/dead volume no/ no/ no/ Primary tube sampling/tube sizes/pierces caps on primary tubes yes/10 17 mm diameter, mm depth/no yes/10 16 mm diameter, mm depth/no yes/10 16 mm diameter, mm depth/no Sample barcode reading capability/autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes Barcode placement per CLSI standard Auto2A Measures number of tests remaining/short sample detection yes/yes no/yes no/yes Clot detection/reflex testing capability yes/no yes/no yes/no Hemolysis detection-quantitation/turbidity detection-quantitation no/no no/no no/no Dilution of patient samples onboard/automatic rerun capability yes/no yes/no yes/no Sample volume can be reduced to rerun out-of-linear range high results/ no/no no/no no/no Time between initial result and reaspiration of sample for rerun Autocalibration or autocalibration alert no no no Number of calibrators required for each analyte assay dependent assay dependent assay dependent Calibrants can be stored onboard/average calibration frequency no/per plate no/within each run no/within each run Multipoint calib. supported/multiple calibs. stored for same assay no/no no/no no/no How often QC required per plate with every assay with every assay Onboard real-time QC/Support multiple QC lot Nos. per analyte no/no no/yes no/yes Automatic shutdown/startup is programmable/startup time yes/yes/15 minutes yes/yes/5 minutes yes/yes/5 minutes Stat time to completion of βhcg test Time delay from ordering stat test to aspiration of sample Throughput per hour for three analytes on each specimen, in number of assay dependent/ assay dependent/ assay dependent/ Data-management capability/instrument vendor supplies LIS interface onboard/yes (additional cost) onboard/yes (additional cost) onboard/yes (additional cost) LIS interfaces up and running in active user sites yes (Cerner, Sunquest, Soft, Orchard, etc.) yes (Cerner, Sunquest, Soft, Orchard, etc.) yes (Cerner, Sunquest, Soft, Orchard, etc.) Bidirectional interface capability yes (broadcast download and host query) yes (host query) yes (host query) Interface available (or will be) to auto specimen handling system no no no yes/yes/yes no/yes/yes no/yes/yes On-site response time of service engineer 24 hours (contract dependent) 24 hours (contract dependent) 24 hours (contract dependent) Mean time between failures/to repair failures Average time to complete maintenance by lab personnel daily: <15 minutes; weekly: <30 minutes; monthly: <1 hour daily: 5 minutes; weekly: 20 minutes; monthly: 20 minutes daily: 10 minutes; weekly: 20 minutes; monthly: 20 minutes Onboard maintenance records/maintenance training demo module no/no no/no no/no List price/targeted bed size or daily volume /various /various /various Training provided with purchase/advanced operator training yes/ yes/ yes/ SmartKit, direct-load reagents can be loaded at any time, in any order, thus reducing preanalytic time by more than 60% of traditional ELISA automation systems; the 2-D barcode on each SmartKit is detected, loaded, and tracked in real time, continuously; open platform capacity allows for a very flexible test menu to automate Alere s ~100 ELISA assays along with any other ELISA manufacturer and eliminates carryover possibility with disposable tips combined with the Alere ELISA product line and the ability to automate enteric assays and front-end dilute Athena Multi-Lyte assays, the DS2 provides an efficient, open, fully automated solution for customers looking for laboratory automation open DSX platform enables customers to run many ELISAbased assays; modular design allows users to customize system to unique needs; work list load wizard for easy setup; shows graphically where to place reagents, samples, and plates at beginning of each run; complete daily maintenance in less than 5 minutes, including removal of consumables and rinsing washer

3 40 CAP TODAY JUNE 2017 Part 3 of 21 Arlington Scientific Awareness Technology Awareness Technology Mike LaDow mladow@arlingtonscientific.com Jamie Ristaino info@awaretech.com Jamie Ristaino info@awaretech.com 1840 N. Technology Drive, Springville, UT SW Martin Highway, Palm City, FL SW Martin Highway, Palm City, FL Name of instrument/first year sold/where designed ASI Infinity/1998/U.S. ChemWell Fusion/2014/U.S. ChemWell 2910/1998/U.S. Country where manufactured/where reagents manufactured U.S./U.S. U.S./ U.S./ Number of units in clinical use in U.S./Outside U.S. 80/4,350 0/ /4,350+ Operational type/model type/sample handling system batch/benchtop/rack batch/benchtop/rack batch/benchtop/rack Dimensions in inches (H W D)/Instrument footprint in sq. feet / / /4 unlimited (open system) unlimited (open system) unlimited (open system) Tests not available in U.S. but available in other countries unlimited (open system) unlimited (open system) unlimited (open system) Tests in development Tests not available on other manufacturers Fully automated microplate system yes yes yes Number of each analyte performed in separate disposable unit 12 up to 12 up to 12 Number of wells in microplate minimum strip: 8; maximum full plate: 96 minimum strip: 8; maximum full plate: 96 minimum strip: 8; maximum full plate: 96 Methods supported/separation methods enzyme immunoassay/coated microwell enzyme immunoassay (ELISA) and CLIA/coated microwell enzyme immunoassay/coated microwell plate, strips Number of different measured assays onboard simultaneously 12 up to 12 up to 12 Number of different assays programmed, calibrated at once unlimited unlimited unlimited Number of user-definable (open) channels unlimited unlimited unlimited Number of different analytes for which system accommodates reagent 27/assay dependent 27/assay dependent 27/assay dependent Shortest/Median onboard reagent stability/refrigerated onboard assay dependent/assay dependent/no assay dependent/assay dependent/yes (10 C below ambient) assay dependent/assay dependent/yes (10 C below ambient) Reagents barcoded/information in barcode no/ no/ no/ Same capabilities when 3rd-party reagents used/susceptibility to carryover no/zero no/zero no/zero Walkaway capacity in minutes/specimens/tests, assays assay dependent/96/12 assay dependent/96/12 assay dependent/96/12 System is open (homebrew methods can be used)/liquid or dry system yes/liquid yes/liquid yes/liquid Uses disposable cuvettes/maximum number stored yes/96 yes/96 yes/96 Uses washable cuvettes/replacement frequency yes/assay dependent yes/assay dependent yes/assay dependent Minimum specimen volume required 2 µl 2 µl 2 µl Minimum sample volume aspirated precisely at once/minimum dead volume 2 µl/ 2 µl/ 2 µl/ Supplied with UPS (backup power)/requires floor drain no/no no/no no/no Requires dedicated water system/water consumption no/30 ml no/ no/ Noise generated 15 decibels Has dedicated pediatric sample cup/dead volume no/ no/ no/ Primary tube sampling/tube sizes/pierces caps on primary tubes yes/ mm/no yes/ mm/no yes/ mm/no Sample barcode reading capability/autodiscrimination no/yes no/ no/ Barcode placement per CLSI standard Auto2A Measures number of tests remaining/short sample detection no/no no/no no/no Clot detection/reflex testing capability no/yes no/yes no/yes Hemolysis detection-quantitation/turbidity detection-quantitation no/no no/no no/no Dilution of patient samples onboard/automatic rerun capability yes/no yes/no yes/no Sample volume can be reduced to rerun out-of-linear range high results/ yes/yes yes/yes yes/yes Time between initial result and reaspiration of sample for rerun assay dependent assay dependent assay dependent Autocalibration or autocalibration alert no no no Number of calibrators required for each analyte assay dependent assay dependent assay dependent Calibrants can be stored onboard/average calibration frequency yes/assay dependent yes/assay dependent yes/assay dependent How often QC required shortest interval: each run; longest: daily shortest interval: each run; longest: daily shortest interval: each run; longest: daily Automatic shutdown/startup is programmable/startup time yes/yes/2 minutes yes/yes/2 minutes yes/yes/2 minutes Stat time to completion of βhcg test assay dependent assay dependent assay dependent Time delay from ordering stat test to aspiration of sample 30 seconds 30 seconds 30 seconds Throughput per hour for three analytes on each specimen, in number of assay dependent/96 (2 hours) assay dependent/ assay dependent/ Data-management capability/instrument vendor supplies LIS interface onboard/yes (included) onboard/yes (included) onboard/yes (included) LIS interfaces up and running in active user sites yes LIS interface operates simultaneously with running assays no no no Bidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query) Interface available (or will be) to auto specimen handling system no no no yes/yes/yes yes/yes/yes yes/yes/yes On-site response time of service engineer within 48 hours within 48 hours within 48 hours Mean time between failures/to repair failures 12 months/4 days Average time to complete maintenance by lab personnel daily: <10 minutes; weekly: <10 minutes; monthly: <10 minutes daily: <10 minutes; weekly: <10 minutes; monthly: <10 minutes daily: <10 minutes; weekly: <10 minutes; monthly: <10 minutes Onboard maintenance records/maintenance training demo module no/ no/no no/no List price/targeted bed size or daily volume $25,000/20 and above $29,000/up to 500 tests per day $25,000/up to 500 tests per day Annual service contract cost (24 hours/7 days) $4,000 $4,500 $4,000 Training provided with purchase/advanced operator training 2 days on site, 2 days at vendor offices/yes 3 days on site/no 3 days on site/no low cost; small footprint; open system dual use as random-access ELISA and CLIA analyzer, capable of performing ELISA and CLIA on the same microwell plate using 8-well microwell strips dual use as random-access biochemistry analyzer when not in EIA mode; optional reagent cooling module

4 JUNE 2017 CAP TODAY 41 Part 4 of 21 Beckman Coulter Beckman Coulter Beckman Coulter Sharon Stieg slstieg@beckman.com Sharon Stieg slstieg@beckman.com Sharon Stieg slstieg@beckman.com 250 S. Kraemer Blvd., Brea, CA S. Kraemer Blvd., Brea, CA S. Kraemer Blvd., Brea, CA Name of instrument/first year sold/where designed Access 2 Immunoassay System/2001/U.S. UniCel DxI 600 Access Immunoassay System/2007/U.S. UniCel DxI 800 Access Immunoassay System/2003/U.S. Country where manufactured/where reagents manufactured U.S./U.S., France, Ireland U.S./U.S., France, Ireland U.S./U.S., France, Ireland Number of units in clinical use in U.S./Outside U.S. Operational type/model type/sample handling system continuous random access/benchtop/rack continuous random access/floor standing/rack, direct track sampling continuous random access/floor standing/rack, direct track sampling Dimensions in inches (H W D)/Instrument footprint in sq. feet / / /17.6 cortisol, EPO, ferritin, folate, intrinsic factor Ab, stfr, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hfsh, hlh, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhcg, unconjugated estriol, fast htsh, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, p2psa, BR-GI-OV monitors, troponin I, vitamin D, and many others cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, stfr, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hfsh, hlh, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhcg, unconjugated estriol, fast htsh, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, stfr, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hfsh, hlh, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhcg, unconjugated estriol, fast htsh, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others Tests not available in U.S. but submitted for clearance AMH AMH Tests not available in U.S. but available in other countries HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM Tests in development AMH Tests not available on other manufacturers Fully automated microplate system no no no Number of each analyte performed in separate disposable unit Methods supported/separation methods chemiluminescence/magnetic particle chemiluminescence/magnetic particle chemiluminescence/magnetic particle Number of different measured assays onboard simultaneously Number of different assays programmed, calibrated at once Number of user-definable (open) channels 0 0 Number of different analytes for which system accommodates reagent 24/100 tests per kit; 50 tests per cartridge 50/100 and 300 tests per kit; 50 tests per cartridge 50/100 and 300 tests per kit; 50 tests per cartridge Shortest/Median onboard reagent stability/refrigerated onboard 14 days/28 days/yes (3 10 C) 14 days/28 days/yes (3 10 C) 14 days/28 days/yes (3 10 C) Reagents barcoded/information in barcode yes/specific cartridge ID, expiration date, lot number, unique reagent pack ID number yes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration Same capabilities when 3rd-party reagents used/susceptibility to carryover no/<10 ppm yes/<10 ppm yes/<10 ppm Walkaway capacity in minutes/specimens/tests, assays up to 180 based on consumable capacity/60/assay dependent based on consumable capacity/60/assay dependent based on consumable capacity/120/ assay dependent System is open (homebrew methods can be used)/liquid or dry system no/liquid no/liquid no/liquid yes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration Uses disposable cuvettes/maximum number stored yes/294 yes/1,000 yes/>1,000 Uses washable cuvettes/replacement frequency no/ no/ no/ Minimum specimen volume required specimen container dependent specimen container dependent specimen container dependent Minimum sample volume aspirated precisely at once/minimum dead volume 5 µl/100 µl 5 µl/80 µl 5 µl/160 µl Supplied with UPS (backup power)/requires floor drain no/no no/no no/no Requires dedicated water system/water consumption no/ no/ no/ Noise generated <70 decibels <65 decibels <60 decibels Has dedicated pediatric sample cup/dead volume yes/100 µl yes/100 µl yes/100 µl Primary tube sampling/tube sizes/pierces caps on primary tubes yes/12 75, and 100, and 100/no yes/12 75, and 100, 16 75, 85, and 100 mm/no yes/12 75, and 100, 16 75, 85, and 100 mm/no Sample barcode reading capability/autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes Barcode placement per CLSI standard Auto2A yes yes yes Onboard test auto inventory (determines volume in container) no no no Clot detection/reflex testing capability yes/yes (Access 2 only) yes/yes yes/yes Hemolysis detection-quantitation/turbidity detection-quantitation no/no no/no no/no Dilution of patient samples onboard/automatic rerun capability no/no yes/yes yes/yes Sample volume can be reduced to rerun out-of-linear range high results/ no/no no/no no/no Time between initial result and reaspiration of sample for rerun 36 seconds 36 seconds 36 seconds Autocalibration or autocalibration alert no yes yes Number of calibrators required for each analyte assay dependent assay dependent assay dependent Calibrants can be stored onboard/average calibration frequency no/28 days no/28 days no/28 days How often QC required 24 hours 24 hours 24 hours Automatic shutdown/startup is programmable/startup time no/no/remains in ready mode no/no/remains in ready mode no/no/remains in ready mode Stat time to completion of βhcg test 15 minutes 15 minutes 15 minutes Time delay from ordering stat test to aspiration of sample 36 seconds 18 seconds 18 seconds Throughput per hour for three analytes on each specimen, in number of 33/100 (36 seconds) /200 (18 seconds) 133/ 400 (9 18 seconds) Data-management capability/instrument vendor supplies LIS interface onboard/yes onboard/yes onboard/yes LIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendors Bidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query) Interface available (or will be) to auto specimen handling system no yes, Beckman Coulter automation systems yes, Beckman Coulter automation systems no/no/no yes/yes/yes yes/yes/yes On-site response time of service engineer Mean time between failures/to repair failures Average time to complete maintenance by lab personnel daily: 15 minutes; weekly: 30 minutes daily: <10 minutes daily: <10 minutes Onboard maintenance records/maintenance training demo module yes/online help with maintenance instructions yes/online help with maintenance instructions yes/online help with maintenance instructions List price/targeted bed size or daily volume $149,800/all volumes and hospital sizes $199,500/ beds or tests per day $325,000/300+ beds or >400 tests per day Training provided with purchase/advanced operator training yes/yes yes/yes yes/yes ability to network up to four Access 2 systems using one LIS interface with remote diagnostics; fully automated userdefined reflex testing; continuous random-access benchtop analyzer uses chemiluminescent technology; allows operators to load consumables on the fly, without interacting with the system high-throughput immunoassay analyzer; uses chemiluminescent technology; allows operators to load consumables on the fly, without interacting with the system; offers ProService remote diagnostic service capability

5 42 CAP TODAY JUNE 2017 Part 5 of 21 Beckman Coulter Beckman Coulter Beckman Coulter Sharon Stieg slstieg@beckman.com Sharon Stieg slstieg@beckman.com Sharon Stieg slstieg@beckman.com 250 S. Kraemer Blvd., Brea, CA S. Kraemer Blvd., Brea, CA S. Kraemer Blvd., Brea, CA Name of instrument/first year sold/where designed UniCel DxC 600i Synchron Access Clinical System/2006/U.S. UniCel DxC 660i Synchron Access Clinical System/2009/U.S. UniCel DxC 680i Synchron Access Clinical System/2009/U.S. Country where manufactured/where reagents manufactured U.S./U.S., France, Ireland U.S./U.S., France, Ireland U.S./U.S., France, Ireland Number of units in clinical use in U.S./Outside U.S. >40/>20 5/13 Operational type/model type/sample handling system continuous random access/floor standing/rack-closed tube continuous random access/floor standing/ rack-closed tube continuous random access/floor standing/ rack-closed tube Dimensions in inches (H W D)/Instrument footprint in sq. feet / / /51 cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, stfr, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hfsh, hlh, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhcg, unconjugated estriol, fast htsh, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others cortisol, EPO, ferritin, folate, intrinsic factor Ab, stfr, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hfsh, hlh, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhcg, unconjugated estriol, fast htsh, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, stfr, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hfsh, hlh, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhcg, unconjugated estriol, fast htsh, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others Tests not available in U.S. but available in other countries CMV IgG, CMV IgM, rubella IgM HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM Tests in development AMH AMH AMH Tests not available on other manufacturers Fully automated microplate system no no no Number of each analyte performed in separate disposable unit Methods supported/separation methods chemiluminescence, enzyme immunoassay/magnetic particle chemiluminescence, enzyme immunoassay/magnetic particle chemiluminescence, enzyme immunoassay/magnetic particle Number of different measured assays onboard simultaneously Number of different assays programmed, calibrated at once Number of user-definable (open) channels Number of different analytes for which system accommodates reagent 89/100 tests per kit (immunoassay); 300 tests per container (general chemistry) 115/100 tests per kit (immunoassay); 300 tests per container (general chemistry) 115/100 tests per kit (immunoassay); 300 tests per container (general chemistry) Shortest/Median onboard reagent stability/refrigerated onboard 14 days/28 days/yes (3 10 C) 14 days/28 days/yes (3 10 C) 14 days/28 days/yes (2 10 C) Reagents barcoded/information in barcode yes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration yes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration Same capabilities when 3rd-party reagents used/susceptibility to carryover yes/<10 ppm yes/<10 ppm yes/<10 ppm Walkaway capacity in minutes/specimens/tests, assays 60/76/assay dependent 60/76/assay dependent 60/76/assay dependent System is open (homebrew methods can be used)/liquid or dry system no/liquid no/liquid no/liquid Uses disposable cuvettes/maximum number stored yes/125 yes/125 yes/125 Uses washable cuvettes/replacement frequency yes/ yes/ yes/ Minimum specimen volume required container dependent container dependent container dependent Minimum sample volume aspirated precisely at once/minimum dead volume 3 µl/20 µl (general chemistry) 3 µl/80 µl 3 µl/80 µl Supplied with UPS (backup power)/requires floor drain yes/yes yes/yes yes/yes Requires dedicated water system/water consumption yes/16 L per hour yes/up to 16 L per hour yes/up to 16 L per hour yes/specific cartridge ID, No. of available tests, expiration date, lot No., calibration expiration, within lot calibration Noise generated Has dedicated pediatric sample cup/dead volume yes/ yes/ yes/ Primary tube sampling/tube sizes/pierces caps on primary tubes yes/13 75 and 100, and 92, mm/yes yes/13 75 and 100, and 75, mm/yes yes/13 75 and 100, and 92, mm/yes Sample barcode reading capability/autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes Barcode placement per CLSI standard Auto2A yes yes yes Clot detection/reflex testing capability yes/yes yes/yes yes/yes Hemolysis detection-quantitation/turbidity detection-quantitation yes/yes (general chemistry) yes/yes (general chemistry) yes/yes (general chemistry) Dilution of patient samples onboard/automatic rerun capability yes/yes yes/yes yes/yes Sample volume can be reduced to rerun out-of-linear range high results/ yes/yes yes/yes yes/yes Time between initial result and reaspiration of sample for rerun chemistry dependent chemistry dependent chemistry dependent Autocalibration or autocalibration alert Number of calibrators required for each analyte assay dependent assay dependent assay dependent Calibrants can be stored onboard/average calibration frequency no/28 days no/28 days no/28 days How often QC required 24 hours 24 hours 24 hours Automatic shutdown/startup is programmable/startup time no/no/remains in ready mode no/no/remains in ready mode no/no/remains in ready mode Stat time to completion of βhcg test 15 minutes 15 minutes 15 minutes Time delay from ordering stat test to aspiration of sample 1 minute (general chemistry) 1 minute (general chemistry) 1 minute (general chemistry) Throughput per hour for three analytes on each specimen, in number of 90/720 (40 seconds) (general chemistry) 90/720 (40 seconds) (general chemistry) 90/720 (40 seconds) (general chemistry) Data-management capability/instrument vendor supplies LIS interface optional add-on/yes (additional cost) LIS interfaces up and running in active user sites all major LIS vendors Bidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query) Interface available (or will be) to auto specimen handling system yes, Beckman Coulter automation systems yes, Beckman Coulter automation systems yes, Beckman Coulter automation systems yes/yes/validate for the DxC 600i yes/yes/yes yes/yes/validate for the DxC 680i On-site response time of service engineer Mean time between failures/to repair failures Average time to complete maintenance by lab personnel Onboard maintenance records/maintenance training demo module yes/online help with maintenance instructions yes/online help with maintenance instructions yes/online help with maintenance instructions List price/targeted bed size or daily volume $325,000/moderate volume, <300 samples per day $575,000/high volume, samples per day $610,000/high volume, samples per day Annual service contract cost (24 hours/7 days) per negotiated contract per negotiated contract per negotiated contract Training provided with purchase/advanced operator training yes/yes yes/yes yes/yes performs parallel processing of immunoassay and chemistry tests on one system; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability performs parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and closedtube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability performs parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and closedtube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

6 JUNE 2017 CAP TODAY 43 Part 6 of 21 Beckman Coulter Beckman Coulter biomérieux Inc. Sharon Stieg slstieg@beckman.com Sharon Stieg slstieg@beckman.com Customer Service Team customerdelight@biomerieux.com 250 S. Kraemer Blvd., Brea, CA S. Kraemer Bvld., Brea, CA Rodolphe St., Durham, NC Name of instrument/first year sold/where designed UniCel DxC 860i Synchron Access Clinical System/2009/U.S. UniCel DxC 880i Synchron Access Clinical System/2008/U.S. VIDAS 3/2013/Italy Country where manufactured/where reagents manufactured U.S./U.S., France, Ireland U.S./U.S., France, Ireland Italy/France Number of units in clinical use in U.S./Outside U.S. >10/>25 >40/>150 Operational type/model type/sample handling system continuous random access/floor standing/rack-closed tube continuous random access/floor standing/rack-closed tube random access, continuous random access/benchtop/rack Dimensions in inches (H W D)/Instrument footprint in sq. feet / / /5.2 cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, stfr, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hfsh, hlh, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhcg, unconjugated estriol, fast htsh, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, stfr, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hfsh, hlh, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhcg, unconjugated estriol, fast htsh, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others procalcitonin (PCT), D-dimer exclusion, Lyme IgG, Lyme IgM, C. difficile GDH, C. difficile toxin A&B, measles IgG, mumps IgG, rubella IgG, varicella IgG, HCG, H. pylori, toxo IgG, toxo IgM Tests not available in U.S. but available in other countries HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM ferritin; NT-proBNP; CK-MB; high sensitive troponin I; troponin I Ultra; X protein C, von Willebrand factor (allergen-specific IgG for research only); LH, FSH, estradiol II, progesterone, prolactin, testosterone, cortisol S; Staller test, Stallertroph, Stallergy; TSH, FT4, T3, T4, TSH3G, anti-tpo, anti-tg, FT3; toxo; TSPA; AFP, CEA-(S), FPSA, CA 15-3, CA 19-9, CA 125-II; CMV, EBV, HIV, HBs Ag, anti-hbs, anti-hbc total, HBc IgM, HBe-anti-HBe, HAV IgM, anti-hav total, anti-hcv, rotavirus; C. difficile, H. pylori IgG, vitamin D, total IgE, others Tests in development AMH AMH Tests not available on other manufacturers Lyme IgG, Lyme IgM Fully automated microplate system no no no Number of each analyte performed in separate disposable unit 1 test per strip Methods supported/separation methods chemiluminescence, enzyme immunoassay/magnetic particle chemiluminescence, enzyme immunoassay/magnetic particle fluorescence, enzyme immunoassay, enzyme immunoassay coated, solid phase receptacle pipetting device/ Number of different measured assays onboard simultaneously Number of different assays programmed, calibrated at once total menu Number of user-definable (open) channels Number of different analytes for which system accommodates reagent 120/100 tests per kit (immunoassay); 300 tests per container 120/100 tests per kit (immunoassay); 300 tests per container unit-dose format 30 or 60/30 or 60 (general chemistry) (general chemistry) Shortest/Median onboard reagent stability/refrigerated onboard 14 days/28 days/yes (2 10 C) 14 days/28 days/yes (2 10 C) / /no Reagents barcoded/information in barcode yes/specific cartridge ID, number of available tests, expiration yes/specific cartridge ID, number of available tests, expiration yes/assay name, lot number, calibration, expiration date, lot number, calibration expiration, within lot calibration date, lot number, calibration expiration, within lot calibration Same capabilities when 3rd-party reagents used/susceptibility to carryover yes/<10 ppm yes/<10 ppm no/zero Walkaway capacity in minutes/specimens/tests, assays 60/112/assay dependent 60/112/assay dependent assay dependent/27/12 System is open (homebrew methods can be used)/liquid or dry system no/liquid no/liquid no/liquid Uses disposable cuvettes/maximum number stored yes/125 no/125 no/32 dilution cups onboard Uses washable cuvettes/replacement frequency yes/ yes/ no/ Minimum specimen volume required container dependent container dependent μl, dependent on assay Minimum sample volume aspirated precisely at once/minimum dead volume 3 µl/80 µl 3 µl/20 µl (general chemistry) 100 μl, dependent on assay/100 μl, dependent on assay Supplied with UPS (backup power)/requires floor drain yes/yes yes/ yes/no Requires dedicated water system/water consumption yes/up to 16 L per hour yes/up to 16 L per hour no/ Noise generated Has dedicated pediatric sample cup/dead volume yes/ yes/ yes/ Primary tube sampling/tube sizes/pierces caps on primary tubes yes/13 75 and 100, and 92, mm/yes yes/13 75 and 100, and 92, mm/yes yes/16 x 100 mm, 13 x 100 mm, 13 x 75 mm, 12 x 75 mm, Nalgen cups size: 13, 5 x 38, 1 mm/no Sample barcode reading capability/autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes Barcode placement per CLSI standard Auto2A yes yes yes Onboard test auto inventory (determines volume in container) yes yes no Measures number of tests remaining/short sample detection yes/yes yes/yes no/yes Clot detection/reflex testing capability yes/yes yes/yes yes/yes Hemolysis detection-quantitation/turbidity detection-quantitation yes/yes yes/yes (general chemistry) yes/yes Dilution of patient samples onboard/automatic rerun capability yes/yes yes/ yes/no Sample volume can be reduced to rerun out-of-linear range high results/ yes/yes yes/yes no/no Time between initial result and reaspiration of sample for rerun chemistry dependent chemistry dependent Autocalibration or autocalibration alert yes Number of calibrators required for each analyte assay dependent assay dependent assay dependent Calibrants can be stored onboard/average calibration frequency no/28 days no/28 days yes/14 or 28 days How often QC required 24 hours 24 hours as per local policy Automatic shutdown/startup is programmable/startup time no/no/remains in ready mode no/no/remains in ready mode yes/yes/5 minutes Stat time to completion of βhcg test 15 minutes 15 minutes 30 minutes Time delay from ordering stat test to aspiration of sample 1 minute (general chemistry) 1 minute (general chemistry) no delay Throughput per hour for three analytes on each specimen, in number of 90/720 (40 seconds) (general chemistry) 90/720 (40 seconds) (general chemistry) 12/36 (20 minutes) Data-management capability/instrument vendor supplies LIS interface onboard/yes (additional cost) LIS interfaces up and running in active user sites Misys, Medtech, McKesson, Advanced Lab Systems, Citation, Cerner, Dawning, Geneysis, Compulab, others Bidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query) Interface available (or will be) to auto specimen handling system yes, Beckman Coulter automation systems yes, Beckman Coulter automation systems no yes/yes/yes yes/yes/yes no/yes/yes On-site response time of service engineer within 24 hours Mean time between failures/to repair failures 385 days/ Average time to complete maintenance by lab personnel weekly: minutes Onboard maintenance records/maintenance training demo module yes/online help with maintenance instructions yes/online help with maintenance instructions yes/no List price/targeted bed size or daily volume $615,000/high to very high volume, 500 1,500 samples per day $650,000/high to very high volume, 750 2,250 samples per day Annual service contract cost (24 hours/7 days) per negotiated contract Training provided with purchase/advanced operator training yes/yes parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and closedtube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability performs parallel processing of immunoassay and chemistry tests; ClozCap technology eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability routine batch testing as well as emergency stat testing, single-dose assay format readily adaptable to batch or single test runs; full traceability with preanalytic automation with barcoding throughout, bi-directional connectivity and remote support; ELISA methodology; dual-function combination solid phase and pipetting device results in no fluid contact with instrument or sample carryover

7 44 CAP TODAY JUNE 2017 Part 7 of 21 biomérieux Inc. Bio-Rad Laboratories Clinical Diagnostics Group Bio-Rad Laboratories Clinical Diagnostics Group Customer Service Team customerdelight@biomerieux.com Greg Stewart greg_stewart@bio-rad.com Greg Stewart greg_stewart@bio-rad.com 100 Rodolphe St., Durham, NC Alfred Nobel Drive, Hercules, CA Alfred Nobel Drive, Hercules, CA (800-2BIO-RAD) (800-2BIO-RAD) Name of instrument/first year sold/where designed VIDAS Immunoassay Analyzer/1991/U.S. PR4100 Microplate Reader/2012/Austria PhD Ix System/2012/France Country where manufactured/where reagents manufactured Italy/France Austria/U.S. France/U.S. Number of units in clinical use in U.S./Outside U.S. 2,200/25,000 85/10 62/ Operational type/model type/sample handling system batch, random access/benchtop/ batch/benchtop/ batch/benchtop/reagent rack Dimensions in inches (H W D)/Instrument footprint in sq. feet VIDAS 30: /4.5; MiniVIDAS: / /16 procalcitonin (PCT), D-dimer exclusion, Lyme IgG, Lyme IgM, TSH, HCG, LH, FSH, estradiol 2, progesterone, C. difficile GDH, troponin I, CKMB, C. difficile toxin A&B, mumps IgG, rubella IgG, varicella IgG, H. pylori, toxo competition, toxo IgG, toxo IgM, toxo avidity, CMV IgG, CMV IgM, measles IgG, others HIV, HBsAg, HBs, HAV, HAV IgM, HBc, HBc IgM, HCV, syphilis, measles, mumps, VZV, Lyme, toxoplasma, ANA, SSA, SSB open system, method file consists of autoimmune and infectious disease assays, both EIA and IFA methodologies Tests not available in U.S. but available in other countries HBs Ag, anti-hbs total, anti-hbc total, anti-hbc IgM, anti-hbe, HAV IgG, anti-hav total, HIV duo, myoglobin, others Tests in development vitamin D Tests not available on other manufacturers Lyme IgG, Lyme IgM Fully automated microplate system no no no Number of each analyte performed in separate disposable unit 1 test per strip Number of wells in microplate 96 (minimum: 1; maximum: 8) 96 (minimum: 1; maximum: 96) Methods supported/separation methods fluorescence, enzyme immunoassay, enzyme immunoassay enzyme immunoassay/coated microwell fluorescence, enzyme immunoassay/coated microwell coated, solid phase receptacle pipetting device/ Number of different measured assays onboard simultaneously MiniVIDAS: 12; VIDAS: 30 8 enzyme immunoassay or 4 IFA Number of different assays programmed, calibrated at once total menu 8 enzyme immunoassay or 4 IFA Number of user-definable (open) channels no limit Number of different analytes for which system accommodates reagent unit-dose format 30 or 60/ up to 8 different assays/96 Shortest/Median onboard reagent stability/refrigerated onboard / /no / /no 4 hours/ /no Multiple reagent configurations supported no no yes Reagent container placed directly on system for use yes yes Reagents barcoded/information in barcode yes/assay name, lot number, calibration, expiration no/ Same capabilities when 3rd-party reagents used/susceptibility to carryover no/zero yes/ Walkaway capacity in minutes/specimens/tests, assays assay dependent/12 30/12 30 /192/8 EIA or 4 IFA System is open (homebrew methods can be used)/liquid or dry system no/dry yes/dry yes/liquid Uses disposable cuvettes/maximum number stored no/ no/ no/ Uses washable cuvettes/replacement frequency no/ no/ Minimum specimen volume required μl, dependent on assay 70 μl 150 μl Minimum sample volume aspirated precisely at once/minimum dead volume 100 μl, dependent on assay/ 1 μl/150 μl Supplied with UPS (backup power)/requires floor drain yes/no no/no yes/no Requires dedicated water system/water consumption no/ no/ no/ Noise generated Has dedicated pediatric sample cup/dead volume no/ no/ no/ Primary tube sampling/tube sizes/pierces caps on primary tubes no/ /no no/ / yes/12 13 mm diameter, mm height/no Sample barcode reading capability/autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes Barcode placement per CLSI standard Auto2A no yes Onboard test auto inventory (determines volume in container) no no Measures number of tests remaining/short sample detection no/no no/no Automatic detection of adequate reagent or specimen no yes Clot detection/reflex testing capability no/no no/no Hemolysis detection-quantitation/turbidity detection-quantitation no/no no/no Dilution of patient samples onboard/automatic rerun capability no/no yes/no Sample volume can be reduced to rerun out-of-linear range high results/ no/no no/no Time between initial result and reaspiration of sample for rerun Autocalibration or autocalibration alert yes no Number of calibrators required for each analyte assay dependent Calibrants can be stored onboard/average calibration frequency no/14 or 28 days, assay dependent no/each run Multipoint calib. supported/multiple calibs. stored for same assay no/yes yes/no How often QC required shortest interval: 8 hours; longest: 24 hours each run Onboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes no/no Automatic shutdown/startup is programmable/startup time no/no/always remains ready no/no/<5 minutes Stat time to completion of βhcg test 30 minutes Time delay from ordering stat test to aspiration of sample no delay Throughput per hour for three analytes on each specimen, in number of /VIDAS: 20; MiniVIDAS: 8; VIDAS: 60; MiniVIDAS: 24 assay dependent/ Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes no/no Data-management capability/instrument vendor supplies LIS interface onboard/yes (additional cost) onboard/ LIS interfaces up and running in active user sites Misys, Medtech, McKesson, Advanced Lab Systems, Citation, Cerner, Dawning, Geneysis, Compulab, others LIS interface operates simultaneously with running assays yes yes Bidirectional interface capability yes (broadcast download) yes (broadcast download and host query) Interface available (or will be) to auto specimen handling system no no no/yes/yes no/no/no Can order (via modem) malfunctioning part(s) without operator no no On-site response time of service engineer within 24 hours 24 hours Mean time between failures/to repair failures VIDAS: 860 days; MiniVIDAS: 1,200 days/ Average time to complete maintenance by lab personnel weekly: minutes daily: <5 minutes; weekly: 15 minutes; monthly: 30 minutes Onboard maintenance records/maintenance training demo module yes (includes audit trail)/ no/no List price/targeted bed size or daily volume /all bed sizes Training provided with purchase/advanced operator training 2 days on site/no routine batch testing as well as emergency stat testing; ELISA methodology; dual-function combination solid phase and pipetting device results in no fluid contact with instrument or sample carryover; single-dose assay format readily adaptable to batch or single test runs open platform with assay programming wizard; bidirectional LIS with broadcast download, capable of running IFA and EIA; accurate down to 1 μl, IFA hyperwash for cleaner backgrounds, precise well-to-well timing; networking capabilities for multiple workstations