Automated ID Serology Analyzer

Automated ID Serology Analyzer

SALIENT CHARACTERISTICS

General instrument characteristics include being able to run enzyme immunoassay (EIA) for infectious disease serology testing.  Specifically, the instrument MUST be able to run the QuantiFERON TB Gold-Plus assay for detection of M. tuberculosis immune responses.

Characteristics:

1. Automated sample ID scanning and reagent ID scanning.
2. Bar-coded data entry capabilities.
3. Bi-directional interface for host connection to connect to LIS.
4. Ability to receive approval for Authority to Operate (ATO) on Defense Health Agency (DHA) network within 1-year from start of contract and meet cyber security/network requirements.
5. FDA-approved assays for:
   1. QuantiFERON TB Gold Plus
   2. Measles IgG
   3. Mumps IgG
   4. Rubella IgG
   5. VZV IgG
   6. Calprotecting Ag
   7. H. Pylori Ag
6. Additional infectious disease serology assays may be added in the future to include:
   1. Rubella IgM
   2. CMV IgG/IgM
   3. Toxoplasma IgG/IgM
   4. HSV 1/2 IgG
7. Preference will be given to platforms that have FDA-approved assays for the additional analytes specified.
8. If a combined panel (e.g. MMRV, etc.) format is the only test format, must be able to do cost per reportable.
9. System cannot require remote diagnostics for troubleshooting or required software updates.
10. Random access or the ability run multiple assays at the same time with the ability to process at least 15,000 specimens annually.
11. Ready-to-use reagents, bar-coded cassettes.
12. Must be able to provide system installation and set-up.
13. Computer system (CPU, Monitor, Keyboard, Printer,) with Custom Assay Protocol Files for Qiagen QuantiFERON TB Gold PLUS available, UPS for all instruments for the life of the instruments. Assay protocol files and results analysis/interpretation for other serology EIA/CLIA assays available through manufacturer or vendor for listed assays.
14. Must be able to provide complete system validation (or assist facility with validation, as needed).
15. Vendor will provide sufficient kits, at no cost to the Government, for verification of each assay as described in the verification plan signed by the Medical Director, Department of Pathology, Madigan Army Medical Center.
16. Vendor will provide initial “operator level” on-site training at no additional cost to the government for 4 technicians.
17. Operate within the existing environmental conditions of 15-35 °C and 15-75% relative humidity.
18. Must be able to run FDA-approved assays listed at a minimum, either supplied by vendor or by operating as open source system able to accommodate regents and tests from other manufacturers. 
19. Pipette tip locking and monitoring technology, including anti-droplet control (ADC) for reliable sample transfer. Disposable tips preferred. If system uses fixed tips, manufacturer must have completed a robust carry-over study or assist facility with design and completion of study.
20. If available, external controls and/or calibrators for each assay should be included as part testing from the same manufacturer. Preference will be given to test assays that include external controls to meet requirements of Clinical Laboratory Improvements Acts of 1988.
21. The systems must improve overall productivity in the Serology Lab, reducing the need for repeat testing thus reducing reagent waste.
22. The system should not require monitoring/user intervention during a run and should be 100% “walk-away” system once the run is started.
23. Must require less than 1 h tech time for any pre-analytical processing steps or instrument/reagent preparation.
24. Provide reliable technical support within 1 hr remotely during normal business hours and on-ground field service within 48 hours of system issues that cannot be resolved remotely.
25. Any calculations for results interpretation for QuantiFERON TB Gold PLUS and other serological assays indicated are automatic (i.e. no manual manipulation of data or additional system hardware requirements) with direct reporting of results to LIS.