Salient Characteristics Draft.pdf
PDF 118 KB Posted
- Attached to
- Molecular Diagnostics Analyzer and Reagents for detection of the Antibodies and Pathogens
- Solicitation number
- W81K0225QA047
- Issued by
-
Department of the Army Medical Command
About this file
The document is a draft Salient Characteristics file specifying technical requirements for a molecular diagnostics analyzer and reagents. The system must perform FDA-approved, qualitative nucleic acid amplification testing for four specific viruses: Herpes simplex virus (HSV 1/2), Congenital cytomegalovirus (CMV), Candida auris (C. auris), and Varicella Zoster Virus (VZV). Key technical requirements include direct specimen amplification without additional extraction, result generation in under 1.5 hours, processing at least 8 samples per run, automated sample ID scanning, bar-coded data entry, and a bi-directional laboratory information system interface.
Additional requirements mandate the system fit on a standard lab benchtop (24x24x24 inches), operate within 15-32°C and <80% relative humidity, provide emergency services within 24-48 hours, offer system installation, staff training, complete system validation, and obtain an Authority to Operate (ATO) on the DHA network within one year. The system must improve overall molecular diagnostics productivity, reduce repeat testing and reagent waste, enable overnight operation, and not require monitoring during runs or remote diagnostics for troubleshooting. The goal is to identify the specified viruses at clinically relevant infection levels with the ability to distinguish between HSV-1 and HSV-2 in a single assay.
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| File | Type | Posted |
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| SOW DRAFT.pdf |
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Text version
SALIENT CHARACTERISTICS
General instrument characteristics include an instrument(s) capable of performing FDA-approved, qualitative nucleic acid amplification testing (NAAT) for Herpes simplex virus (HSV 1/2), Congenital cytomegalovirus (CMV), Candida auris (C. auris), and Varicella Zoster Virus (VZV) with specific functionality and performance-based requirements of the system.
A. Characteristics:
1. FDA-approved, qualitative molecular assays for:
a. HSV-1/2 from cutaneous & mucocutaneous swabs to include anogenital and non-anogenital sites, and CSF
b. VZV from cutaneous & mucocutaneous swabs, and CSF
c. CMV from saliva and urine
d. C. auris from the armpits and groins
2. Must be capable of direct amplification of specimen without an additional extraction step.
3. Generates results in less than 1.5 hours.
4. Must be capable of processing at least 8 samples per run per instrument without reagent waste if less than the full cartridge/disk/cassette is utilized.
5. Must have an extraction and amplification process control.
6. Must supply external positive controls to meet lab QC requirements.
7. Automated sample ID scanning on the system to ensure sample/assay/reagent positive match.
8. Bar-coded data entry capabilities.
9. Must process liquid level detection capability to confirm adequate sample and reagent levels.
10. Bi-directional interface for host connection to connect to Laboratory Information System
(LIS) and system must be capable of automatically sending patient results to the LIS.
11. Ready-to-use reagents, bar-coded cassettes/disks/cartridges.
12. Must have an open channel for additional molecular assays that are LDT or non-FDA approved primers.
13. FDA-approved molecular detection for additional pathogens may be incorporated on this testing platform in the future.
14. Dimensions for individual analyzer must be able to fit on a standard lab benchtop and be no greater than 24 in x 24 in x 24.
15. Contractor must be able to perform emergency services within 24 hours of service call and completed within 48 hours of arrival.
16. Must be able to provide system installation and set-up.
17. Computer system (CPU, Printer) & UPS for all instruments for the life of the instruments will be supplied by the vendor.
18. Must be able to provide complete system validation/verification (or assist facility with validation, as needed).
19. Must be able to provide training for staff how to use and troubleshoot the system.
20. Operate within the existing environmental conditions of 15-32°C and <80% relative humidity.
21. The test(s) specifically identifies HSV-1/2, VZV, CMV and C. auris at clinically relevant infection levels.
22. Assay can distinguish between HSV 1 and HSV 2 in a single assay.
23. The systems must improve overall productivity in the Molecular Diagnostics Section, reducing the need for repeat testing thus reducing reagent waste.
24. The system should not require monitoring/user intervention during a run.
25. System cannot require remote diagnostics for troubleshooting or required software updates.
26. Overnight operation capabilities from start of specimen to finish.
27. Must be able to obtain an ATO to operate on the DHA network within 1 year following start of contract and meet cyber security/network requirements.
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