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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 assay shall be FDA approved for HIV-1 Genotype Resistance testing for the protease/RT gene regions. |
| 2 |
| The assay for the HIV-1 Integrase gene shall be Research Use Only (RUO) and manufactured as a full test kit under GMP.. |
| 3 |
| The assays shall be designed for fractionation of sequencing reactions by capillary electrophoresis on the Abbott Applied Biosystems 3130 xl or 3500 xl Genetic Analyzer. |
| 4 |
| The assays shall be capable of providing HIV-1 Genotype Test results on specimens having a HIV-1 Viral Load at or greater than 2,000 RNA copies/mL. |
| 5 |
| The assays shall provide amplified DNA product (RT-PCR) that is visible on an agarose gel and be of sufficient quantity for use in sequencing reactions. |
| 6 |
| Any software upgrades shall be part of the FDA cleared assay for HIV-1 Genotype Resistance Testing of the protease and reverse transcriptase gene regions. |
| 7 |
| The software to the assay shall be capable of providing HIV-1 Resistance Reports for all approvedprotease, NNRTIs, NRTIs and Integrase drugs. These reports shall provide information on mutationsand level of resistance to the HIV-1 drug; i.e. no resistance (sensitive), possible resistance (low orintermediate resistance), resistant (not sensitive). |
| 8 |
| The contractor shall sequester same lot numbers for the supplies delivered. |
(End)
Department of the Army Medical Command