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| Instrument name/First year sold | ACL TOP 350/300 CTS/2012 |
| Number of units installed in U.S./Outside U.S. | 4,000+/8,000+ (all ACL models combined) |
| Number of contracts signed between 1/1/18 and 11/15/18 | — |
| Country where analyzer designed/Manufactured | U.S./U.S. |
| Operational type | continuous random access |
| Reagent type | open reagent system |
| Operates on whole blood or spun plasma | spun plasma |
| Sample handling system | racks, continuous loading of primary tubes |
| Model type | benchtop |
| Dimensions (H × W × D)/Weight/Instrument footprint | 29 × 32 × 33 in./200 lbs./8 sq. ft. |
| FDA-cleared clotting-based tests | PT, APTT, fibrinogen, TT, factors, FVIII (with VWF) |
| FDA-cleared chromogenic tests | anti-Xa, AT |
| FDA-cleared immunologic tests | Domain 1, D-Dimer, D-Dimer HS, heparin-induced thrombocytopenia |
| Other FDA-cleared tests | — |
| User-defined tests in clinical use | — |
| Tests submitted for 510(k) clearance | — |
| Tests in development but not yet submitted | VWF (RCo), direct oral anticoagulants (dabigatran, rivaroxaban, apixaban) |
| Methodologies supported | LED optical detection: clotting, chromogenic, and immunologic |
| Operator must load sep. reagent pack per specimen/Test run | no/no |
| Number of different measured assays onboard simultaneously | 500 |
| Number of different assays programmed and calib. at one time | 500 |
| Number of user-definable (open) channels | 250 |
| Of those defined, number active simultaneously | 30 |
| Factor assays require manual manipulation or dilutions | no |
| Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard | 24/varies/yes |
| Multiple reagent configurations supported | yes |
| Reagents, consumables loaded without interrupting testing | yes |
| Same capabilities when third-party reagent used | yes |
| Maximum time same lot number of reagents can be used | 18 months |
| Walkaway capacity: Number of specimens/Number of tests | 40/800 |
| Minimum sample volume aspirated precisely at one time | 4 µL |
| Standard specimen volume required to run PT or PTT/ Factor VIII activity | 50 µL/— |
| Disposables used/Price of each | cuvettes/varies |
| Supports direct-from-track sampling | no |
| Primary tube sampling supported/Pierces caps on primary tubes | yes/yes |
| Sample/Reagent barcode reading capability | yes/yes |
| Onboard test automatic inventory | yes |
| Measures No. of tests remaining/Short sample detection | yes/yes |
| Clot detection as preanalytical variable in plasma sample | optional |
| Auto. detects adequate reagents for aspiration and analysis | yes |
| Hemolysis/Turbidity detection-quantitation | optional/optional |
| Dilution of patient samples onboard | yes |
| Automatic rerun capability/Auto reflex testing capability | yes/yes |
| Lag time during which hypercoagulable sample not detected | no |
| Read time extended for prolonged clotting times | yes |
| User can set different-than-standard: | |
| • Reagent volumes/Sample volumes | yes/yes |
| • No. and sources of reagent | yes |
| • Incubation times/Reading times | yes/yes |
| Autocalib. or autocalib. alert/Multipoint calib. supported | yes/yes |
| Auto shutdown/Auto startup programmable | not needed/not needed |
| Stat time to complete all analytes/Throughput per hour for: | |
| • PT alone | <3 minutes/110 specimens |
| • PT, PTT | <6 minutes/55 specimens |
| • Fibrinogen | <6 minutes/60 specimens |
| • Factor VIII activity assay | <11 minutes/38 specimens |
| Time delay from ordering stat to aspiration of sample | 0 seconds |
| Automatic transfer of QC results to LIS | yes |
| Data-management capability | yes |
| Interface supplied by instrument vendor | no |
| Interfaces in active user sites for: | most major vendors |
| Bidirectional interface capability | yes (broadcast download and host query) |
| Results transferred to LIS as soon as test time complete | yes |
| LOINC codes transmitted with all results | no |
| How labs get LOINC codes for reagent kits | — |
| Electronic interface available (or will be) to automated (or robotic) specimen handling system | no |
| Modem servicing | in development |
| Time required for maintenance by lab personnel | daily: <10 minutes; weekly: 10 minutes; monthly: none |
| Onboard maintenance records | yes |
| Training provided with purchase | 4 days at vendor offices |
| Approximate number of training hours needed per tech | 24–40 |
| List price | — |
| Annual service contract cost (24/7)/Warranty with purchase | —/1 year |
| Distinguishing features (supplied by company) | complete standardization solution; on-demand HIT testing; detects underfilled samples; 671-nm LED detection minimizes interferences from HIL, samples with HIL levels exceeding assay threshold are flagged; complete HemosIL assay menu, including D-Dimer HS with VTE exclusion; HemosIL plasma sets for validation of INR test system; HemosIL liquid anti-Xa with universal calibration curve for UFH and LMWH |
| Note: a dash in lieu of an answer means company did not answer question or question is not applicable | |
| All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. |
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