Company | . | wdt_ID | Name of instrument | Contact | Model type | Dimensions (H × W × D)/Weight/Instrument footprint | No. of units in clinical use in U.S./Outside U.S. (countries) | Composition of installs: Hospital lab/Reference lab/Other | Targeted daily, monthly, annual test volume | Operational type | Country where analyzer designed/Manufactured | Company manufactures instrument | FDA-approved clotting-based tests | FDA-approved chromogenic tests | FDA-approved immunologic tests | Other FDA-approved tests | User-defined tests in clinical use | Tests in development or awaiting FDA 510(k) clearance | Methodologies supported | Number of different measured assays onboard simultaneously | Number of different assays programmed and calib. at one time | No. of user-definable (open) channels/No. active simultaneously | Factor assays require manual manipulation or dilutions | Test throughput per hour/Assay run time | Design of sample-handling system | Operates on whole blood or spun plasma | Reagent type | Reagent barcode-reading capability | No. of reagent containers held onboard/Reagents ready to use | Reagent lot tracking/Reagent inventory/Reagents refrigerated | onboard | Reagents, consumables loaded without interrupting testing | Instrument uses proprietary or third-party reagents | Maximum time same lot number of reagents can be used | Walkaway capability/Walkaway duration | Min.–max. specimen volume that can be aspirated at one time | Min. sample volume required for PT/PTT/Factor VIII activity | Types of disposables used | Primary tube sampling supported/Pierces caps on primary tubes | Accommodates most standard tube sizes/Nonstandard sizes | Sample barcode-reading capability/Autodiscrimination | Auto tracks product volume/Measures number of tests remaining | Short sample detection | Clot detection as preanalytical variable in plasma sample | Auto detects adequate reagents for aspiration or analysis | Detection or quantitation for hemolysis, turbidity, icterus, lipemia | Dilutes patient samples onboard | Automatic rerun capability/Auto reflex testing capability | Lag time during which hypercoagulable sample not detected | User can adjust reagent volumes/Sample volumes | User can adjust No. of reagents/Sources of reagents | User can adjust incubation times/Reading times | Read time extended for prolonged clotting times | Autocalibration/Calibrants stored onboard | Multipoint calibration supported/Recommended frequency | Stat time to complete all analytes/Throughput per hour for: | • PT alone | • PT, PTT | • Fibrinogen | • Factor VIII activity assay | • D-dimer | Time delay from ordering stat to aspiration of sample | How labs get LOINC codes for results | Onboard real-time QC/Onboard software capability to review QC | Information that can be barcode-scanned on instrument | Compatible with laboratory automation systems | Data-management capability/LIS or EHR systems interfaced | Interface supplied by instrument vendor | Results transferred to LIS as soon as test time complete | Bidirectional interface capability | Remote servicing provided/UPS backup power supply | Instrument connections to transfer information | Interface standards supported | Information transferred to data-management software | Avg. time for basic user training | Approximate scheduled maintenance time | Maintenance records kept onboard | Warranty with purchase/Annual service contract cost (24/7) | Distinguishing features (supplied by company) | Additional Features |
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Bio/Data Corp. | 1 | Platelet Aggregation Profiler PAP-8E | Bio/Data Corp. Mary Brown customer.service@biodatacorp.com Horsham, PA 215-441-4000 or 800-257-3282 www.biodatacorp.com |
Benchtop | 21.5–25.5 × 19.5 × 21.7 in./40 lbs./4 sq. ft. | >500/>300 (Canada, EEC, Middle East, Asia, Far East, North Africa) | 80%/15%/5% (unspecified) | — | batch, random access | U.S./U.S. | yes (also sold by möLab, Sentinel Diagnostics, Werfen, Alpha Labs, Sysmex, Analis) | — | — | ristocetin cofactor activity, HIT/HIPA, RIPA; others | platelet activation, spontaneous platelet aggregation, sticky platelets, washed platelet aggregation, others | — | — | turbidimetric, immunologic (agglutination, Ab-Ag tests) | 255 | 255 | 8-Aug | yes (manual manipulation and dilutions) | 540 (up to 60 samples in throughput)/up to 8 hours | manual | spun plasma | open reagent system (liquid, lyophilized [reconstituted manually]) | yes, for all tests | —/requires operator prehandling | yes/no/no | yes (reagents and consumables) | user’s option | 2 years | yes/8 specimens or 8 tests | — | — | test cuvettes, micro stir bars, pipette tips, sample tubes and caps | no/no | no/no | —/yes | no/no | no | no | no | detection for hemolysis, turbidity, icterus, lipemia | no | no/no | no | yes/yes | yes/yes | yes/yes | — | yes/no | yes/annually | — | — | — | — | — | — | email query | no/yes | reagent lot No. | no | onboard/none | no | no | no | no/no | — | — | — | 1.5 days (at customer site) | weekly: 15 minutes; monthly: 30 minutes | no | yes/$2,050 | 2-year instrument warranty; 3-year in-lab PC service; up to 9 reported test results per channel; hybrid annual calibration service | ||||
Chrono-log Corp. | 2 | Optical Aggregation Systems Models 490 4+, 490 4+4 | Chrono-log Corp. Sal Pema sal@chronolog.com Havertown, PA 610-853-1130 or 800-247-6665 www.chronolog.com |
Benchtop | per each 4-channel module: 8.5 × 14 × 15 in./19.3 lbs./1.5 sq. ft. | — | — | — | discrete | U.S./U.S. | yes (also sold via distribution partners) | — | — | platelet agglutination with ristocetin | LTA platelet aggregation, ristocetin cofactor assay | LTA platelet aggregation, ristocetin cofactor assay | — | turbidimetric for measuring platelet aggregation in PRP and ristocetin cofactor assay | 4–8 | 4–8 | 4–8/4–8 | yes (manual dilutions) | 6 (24–48 tests in throughput)/5 min. minimum | manual | spun plasma | self-contained multiuse vials; open reagent system (liquid, lyophilized [reconstituted manually]) | no | —/requires operator prehandling | no/no/no | yes (consumables) | proprietary reagents | 18 months–3 years | yes/5 min. or 4–8 specimens or 4–8 tests | 250–500 µL | — | cuvettes, stir bars, pipette tips | no/no | no/no | no/no | no/no | no | no | no | no | no | yes/no | no | yes/yes | yes/yes | yes/yes | yes (selectable on menus) | yes/no | yes/annually | — | — | — | — | — | — | email query | yes/no | barcode scanning not offered | no | onboard/none | no | no | no | no/no | — | — | — | — | preventive maintenance and calibration by clinical engineering recommended annually | yes | yes/— (cost dependent on contract) | continuously monitors and regulates temperature and stirring; optical calibration can be performed by laboratory personnel using no-cost water samples; customized color-coding options | ||||
Chrono-log Corp. | 3 | Whole Blood Optical Lumi-Aggregation System 700-2, 700-4 | Chrono-log Corp. Sal Pema sal@chronolog.com Havertown, PA 610-853-1130 or 800-247-6665 www.chronolog.com |
Benchtop | per each 2-channel module: 8.5 × 14 × 18 in./40 lbs./1.75 sq. ft. | — | — | — | discrete | U.S./U.S. | yes (also sold via distribution partners) | — | — | platelet agglutination with ristocetin | whole blood impedance platelet aggregation, LTA platelet aggregation, platelet dense granule ATP release, ristocetin cofactor assay | whole blood impedance platelet aggregation, LTA platelet aggregation, platelet dense granule secretion, ristocetin cofactor assay | — | turbidimetric for measuring platelet aggregation in PRP and ristocetin cofactor assay, impedance for measuring platelet aggregation in whole blood | 2–4 | 2–4 | 2–4/2–4 | yes (manual dilutions) | 6 (12–24 tests in throughput)/6 min. minimum | manual | whole blood and spun plasma | self-contained multiuse vials; open reagent system (liquid, lyophilized [reconstituted manually]) | no | —/requires operator prehandling | no/no/no | yes (consumables) | proprietary reagents | 18 months–3 years | yes/6 min. or 2–4 specimens or 2–4 tests | 225–500 µL | — | cuvettes, stir bars, disposable electrodes, pipette tips | no/no | no/no | no/no | no/no | no | no | no | no | no | yes/no | no | yes/yes | yes/yes | yes/yes | yes (selectable on menus) | yes/no | yes/annually | — | — | — | — | — | — | email query | yes/no | barcode scanning not offered | no | onboard/none | no | no | no | no/no | — | — | — | 1.5 days (at customer site) | preventive maintenance and calibration by clinical engineering recommended annually | yes | yes/— (cost dependent on contract) | 3 instruments in 1: whole blood/impedance and PRP/LTA aggregometer plus luminometer to measure platelet ATP release; continuously monitors and regulates temperature and stirring; optical calibration can be performed by laboratory personnel using no-cost water samples | ||||
Diagnostica Stago | 4 | STA Compact Max | Diagnostica Stago Matthew Lyons matthew.lyons@us.stago.com Parsippany, NJ 800-222-2624 www.stago-us.com |
Benchtop | 27.75 × 38.18 × 28.73 in./309 lbs./7 sq. ft. | ~1,850/~4,100 (France, Spain, UK, Germany, Denmark, others) | ~96%/3%/1% (veterinary labs, pharmaceutical companies, academic research/educational labs) | daily: >30 (moderate-volume laboratories); monthly: 900; annual: >5,000 | continuous random access | France/France | yes | PT, APTT, TT, fibrinogen, reptilase, factors, proteins C and S, lupus anticoagulant, DRVVT (screen and confirm) | anti-FXa (UFH and LMWH), antithrombin, protein C, plasminogen, FVIII chromogenic | D-dimer, antithrombin antigen, free protein S, total protein S, vWF antigen (all microlatex) | — | APCR, other clotting, chromogenic, and immunological tests with user-defined applications | STA NeoPTimal protime reagent with ISI ~1.0 | mechanical clot detection, chromogenic, immunologic (microlatex) | 80 | 80 | 80/80 | — | 110 (2 tests in throughput)/4.6–7.3 min. (avg. 4.7 min.) | continuous loading sample drawer with continuous random access | spun plasma | self-contained single-use and multiuse vials; open reagent system (liquid, lyophilized [reconstituted manually]) | yes, for all tests | 45/variable (reagent specific) | yes/yes/yes (15°–19°C) | yes (consumables) | user’s option (same capabilities when third-party reagents used) | 18 months | yes/96 specimens or 12 tests | 5–100 µL | 50 µL/50 µL/50 µL | cuvettes, stir bars, cleaner solution | yes/yes | yes/no | yes (Interleaved 2 of 5, UPC, Codabar)/— | yes/no | yes | no | yes (aspiration and analysis) | — | yes | yes/yes | no | yes/yes | yes/yes | yes/yes | yes (selectable on menus) | yes/yes | yes/6 months | 7 minutes/~60 specimens | email query, LOINC codes available in STA Coag Expert | yes/yes | specimen identifier, reagent lot No., quality control ranges, calibrator values | no | onboard/Cerner, Meditech, Clinisys, SCC, McKesson, Epic | contract dependent | yes | yes (broadcast download and host query) | no/yes | data-management system, which in turn connects to LIS; directly to LIS; directly to lab automation system | ASTM 1394-91, ASTM 1381 | device unique identifier, patient ID, specimen ID, result, QC identifier | 3.5 days (at vendor office) | weekly: | yes | yes/— (cost dependent on contract) | viscosity-based, mechanical clot detection; precalibrated D-dimer and fibrinogen reagents, full complement of lupus anticoagulant testing; STA Coag Expert and Coag.One data managers deliver full autoverification, repeat/reflex testing, auto upload of QC to peer group | |||||||||
Diagnostica Stago | 5 | STA Satellite | Diagnostica Stago Matthew Lyons matthew.lyons@us.stago.com Parsippany, NJ 800-222-2624 www.stago-us.com |
Benchtop | 27.4 × 21.1 × 25.5 in./72 lbs./4 sq. ft. | ~550/~2,100 (France, Spain, UK, Germany, Denmark, others) | ~98%/0/2% (veterinary labs, academic research) | daily: ~40; monthly: | random access | France/France | yes | PT, APTT, fibrinogen | anti-FXa (UFH and LMWH), antithrombin | D-dimer | — | — | — | mechanical clot detection, chromogenic, immunologic (microlatex) | 80 | 80 | 80/80 | — | 36 (3 tests in throughput for PT, APTT, fibrinogen)/4.6–7.3 min. (avg. 4.7 min.) | continuous sample loading with positive sample identification, removable sample carousel for 20 primary tubes | spun plasma | self-contained single-use and multiuse vials; open reagent system (liquid, lyophilized [reconstituted manually]) | yes, for all tests | 16/variable (reagent specific) | yes/yes/yes (15°–19°C) | yes (consumables) | user’s option (same capabilities when third-party reagents used) | 18 months | yes/20 specimens or 12 tests | 5–100 µL | 50 µL/50 µL/50 µL | cuvettes, stir bars, cleaner solution | yes/no | yes/no | yes (Interleaved 2 of 5, UPC, Codabar)/no | yes/no | yes | no | yes (aspiration and analysis) | — | yes | yes/yes | no | yes/yes | yes/yes | yes/yes | yes (selectable on menus) | yes/yes | yes/6 months | — | 7 minutes/~6 specimens | email query | yes/yes | specimen identifier, reagent lot No., quality control ranges, calibrator values | no | onboard/Cerner, Meditech, Clinisys, SCC, McKesson, Epic | contract dependent | yes | yes (host query) | no/yes | directly to LIS | ASTM 1394-91, ASTM 1381 | device unique identifier, patient ID, specimen ID, result, QC identifier | 2.5 days (at vendor office) | weekly: | no | yes/— (cost dependent on contract) | viscosity-based, mechanical clot detection; precalibrated D-dimer and fibrinogen reagents, 2-mL 24-hour quality control for PT, APTT, fibrinogen; small footprint for low-throughput labs with limited space | ||||||||
Company | Name of instrument | Model type |
Company:
.:
Name of instrument:
Contact:
Model type:
Dimensions (H × W × D)/Weight/Instrument footprint:
No. of units in clinical use in U.S./Outside U.S. (countries):
Composition of installs: Hospital lab/Reference lab/Other:
Targeted daily, monthly, annual test volume:
Operational type:
Country where analyzer designed/Manufactured:
Company manufactures instrument:
FDA-approved clotting-based tests:
FDA-approved chromogenic tests:
FDA-approved immunologic tests:
Other FDA-approved tests:
User-defined tests in clinical use:
Tests in development or awaiting FDA 510(k) clearance:
Methodologies supported:
Number of different measured assays onboard simultaneously:
Number of different assays programmed and calib. at one time:
No. of user-definable (open) channels/No. active simultaneously:
Factor assays require manual manipulation or dilutions:
Test throughput per hour/Assay run time:
Design of sample-handling system:
Operates on whole blood or spun plasma:
Reagent type:
Reagent barcode-reading capability:
No. of reagent containers held onboard/Reagents ready to use:
Reagent lot tracking/Reagent inventory/Reagents refrigerated:
onboard:
Reagents, consumables loaded without interrupting testing:
Instrument uses proprietary or third-party reagents:
Maximum time same lot number of reagents can be used:
Walkaway capability/Walkaway duration:
Min.–max. specimen volume that can be aspirated at one time:
Min. sample volume required for PT/PTT/Factor VIII activity:
Types of disposables used:
Primary tube sampling supported/Pierces caps on primary tubes:
Accommodates most standard tube sizes/Nonstandard sizes:
Sample barcode-reading capability/Autodiscrimination:
Auto tracks product volume/Measures number of tests remaining:
Short sample detection:
Clot detection as preanalytical variable in plasma sample:
Auto detects adequate reagents for aspiration or analysis:
Detection or quantitation for hemolysis, turbidity, icterus, lipemia :
Dilutes patient samples onboard:
Automatic rerun capability/Auto reflex testing capability:
Lag time during which hypercoagulable sample not detected:
User can adjust reagent volumes/Sample volumes:
User can adjust No. of reagents/Sources of reagents:
User can adjust incubation times/Reading times:
Read time extended for prolonged clotting times:
Autocalibration/Calibrants stored onboard:
Multipoint calibration supported/Recommended frequency:
Stat time to complete all analytes/Throughput per hour for::
• PT alone:
• PT, PTT:
• Fibrinogen:
• Factor VIII activity assay:
• D-dimer:
Time delay from ordering stat to aspiration of sample:
How labs get LOINC codes for results:
Onboard real-time QC/Onboard software capability to review QC:
Information that can be barcode-scanned on instrument:
Compatible with laboratory automation systems:
Data-management capability/LIS or EHR systems interfaced:
Interface supplied by instrument vendor:
Results transferred to LIS as soon as test time complete:
Bidirectional interface capability:
Remote servicing provided/UPS backup power supply:
Instrument connections to transfer information:
Interface standards supported:
Information transferred to data-management software:
Avg. time for basic user training:
Approximate scheduled maintenance time:
Maintenance records kept onboard:
Warranty with purchase/Annual service contract cost (24/7):
Distinguishing features (supplied by company):
Coagulation tests and COVID: inside labs, industry
January 2021— COVID-19 and coagulation testing were up for discussion on Nov. 20 when six people joined CAP TODAY publisher Bob McGonnagle to talk about that and laboratory labor, relationships with industry and hospital administration, and the distribution of testing. “We’re working with all the manufacturers to support rapid point-of-care testing to manage hot spots that will pop up once there is a vaccine,” said Orchard Software’s Curt Johnson.
With Johnson and McGonnagle on the call were Oksana Volod, MD, of Cedars-Sinai Medical Center; Neil Harris, MBChB, MD, of the University of Florida; Annie Winkler, MD, MSc, of Instrumentation Laboratory; Nichole Howard, MBA, of Diagnostica Stago; and Jason Lam, MBA, MLS, of Siemens Healthineers. Drs. Volod and Harris are members of the CAP Hemostasis and Thrombosis Committee.
Dr. Volod, the coagulation findings that have come out of early investigations of COVID have been interesting. What is top of mind for you as you think about coagulation and coagulation systems? What’s most important?
Oksana Volod, MD, director, coagulation consultative service, and associate professor of pathology, Cedars-Sinai Medical Center and David Geffen School of Medicine at UCLA: The good quality of the reagents and the assays available and the quick turnaround time, and potentially new assays that I can bring in-house quickly during this COVID period, specifically assays for fibrinolysis. As you said, there are the specifics of COVID coagulopathy, and now they are pointing out that fibrinolysis shutdown is one of the elements of the COVID coagulopathy. However, only the reference laboratories would have this type of testing. So we are validating fibrinolysis assays on our instruments.
Dr. Harris, are you also seeing a rise in demand for this particular assay?
Neil Harris, MBChB, MD, clinical professor and core laboratory medical director, Department of Pathology, Immunology, and Laboratory Medicine, University of Florida: Yes, we’re seeing a rise in demand for D-dimers and also coagulation factors, especially factor VIII. We used to run factor VIIIs mostly during the day, except in emergencies, and now we are running them around the clock.
The other thing I’d like to point out, and it’s something we have discussed at meetings of the CAP Hemostasis and Thrombosis Committee, is that a number of clinicians have said to me they have certain criteria for D-dimers, but in fact there are different units for D-dimers. For COVID management, as with other situations, there hasn’t been a standardization of D-dimer units.