B08-RFI_Attachment2.doc
DOC document 75 KB Posted
- Attached to
- HIV Testing Supplies
- Solicitation number
- W81XWH-19-Q-0108
- Issued by
-
Department of the Army Medical Command
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Attachment 2
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| File | Type | Posted |
|---|---|---|
| Product_List.pdf | ||
| B08-RFI_Attachment1.doc | DOC document |
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Attachment 2 The requirements listed in the table below shall be accommodated by the responder offering the synthesis and delivery of kits and reagents for HIV-1 genotype resistance testing. Please indicate Y (Yes) or N (No) if your product meets each requirement in the requirements list below, and use the comments column to further justify how your product meets the requirement.
| REQUIREMENTS/ SPECIFICATIONS |
| Meets Requirement? (Y/N) |
| Comments |
| 1 |
| The platform shall be FDA approved for HIV-1 and HCV RNANucleic Acid Amplified Test (NAAT) QualitativeAssay. |
| 2 |
| HIV-1 and HCV Viral Load test kits and reagents shall have FDA clearance for use on the DTS (Direct Tube Sampling). The system shall provide a means to mitigate risks of contamination. |
| 3 |
| RNA NAAT testing assay shall be able to detect the presence of HIV-1 up to 7 to 10 days earlier than the screening 4th generation immunoassays and 26 days before antibodies develop. |
| 4 |
| HCV reagents shall be specific and sensitive detection across HCV genotypes 1 to 6. |
(End)
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