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The required kits, reagents, and consumables are necessary to provide HIV-1 Viral RNA testing services to Military Treatment Facilities (MTFs) to monitor the HIV Viral Load (VL) in plasma specimens received from HIV-1 infected Service members and beneficiaries, HIV VL values are used by clinicians to establish HIV-1 drug treatment regimens for the Department of Army and DoD as part of standard-of-care for HIV-1 infected Soldiers and their beneficiaries. In addition, the HIV Diagnostics and Reference Laboratory (HDRL) performs HCV Viral Load testing upon request and to assist in Diagnosis as HIV infected individuals can also be co-infected with HCV. The tests that will be performed are FDA cleared for performance on the Roche COBAS AmpliPrep/COBAS TaqMan 48 platform system. The HIV-1 VL test is the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0. The HCV VL test is the Roche COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0.
Essential requirements are:
a. The Roche COBAS AmpliPrep instrument (robotic nucleic acid extraction) and the Roche COBAS TaqMan 48 analyzers are either owned by the laboratory or included in the reagent/rental/service agreement as noted above. Test Kits, reagents and consumables must be qualified for performance on this system and have FDA clearance.
b. The HIV-1 and HCV Viral Load tests must utilize a dual probe/ primer target design that provides for redundancy against current and potential future polymorphisms that can interfere with amplification of the target region in the assay.
c. The COBAS AmpliPrep/COBAS TaqMan 48 Analyzer System is a closed platform where reagents, samples and reaction tubes are capped and are not open to the environment. A closed system is preferred to one that is open.
d. The lower limit of detection and quantification must be 20 HIV-1 RNA copies/ml with a maximum at 10 million copies/ml. The lower limit of detection/ quantification for the HCV Viral Load test must be 15 IU/mL with a maximum of 100 million IU/ml.
The Roche COBAS Ampliprep/ COBAS TaqMan test kits, reagents and consumables are the only reagents and supplies that can be used on the COBAS AmpliPrep/COBAS TaqMan 48 Analyzer System. Roche Diagnostics Corporation is the only company that can sell and provide the kits, reagents, consumable and instruments. The reagent, rental and service agreement is critical for HDRL to perform HIV-1 VL testing to provide information critical to physicians for use in monitoring antiretroviral therapy treatment of HIV-1/HCV infected Service members and beneficiaries.
The North American Industry Classification System (NAICS) for this requirement is 334516 and FSC 6630.
Proposed solicitation number: W81XWH-17-T-0221.
This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. This Special Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written
responses are received by the date listed below, which reflects at least fifteen (15) days after the publication of this notice, the solicitation will be issued as sole source.
All questions and responses concerning this notice shall be emailed to Ayi Ayayi at
[email protected].
Interested concerns must identify their capability in writing to the email address listed above no later than 10:00 AM ET, 12 MAY 2017.