CTU240007 - PWS - Mini qPCR.docx

NAVAL MEDICAL RESEARCH UNIT SOUTH

PERFORMANCE WORK STATEMENT: PRECIGENOME

1. Introduction: The Naval Medical Research Unit SOUTH, Clinical Trials Unit, engages in research on influenza as well as COVID-19 diseases as major threats to healthcare personnel worldwide. Research conducted by the Clinical Trial Unit requires performing complex sample analysis. PreciGenome is the only manufacturer of Fast-16™ mini portable PCR instrument. The Fast-16™ mini portable PCR machine is a compact, yet high performance real time quantitative PCR system. Fast-16™ is equipped with a multi-channel fluorescence optical system with the throughput of 1-16 samples per run. Fast-16™ is optimally suited for applications where portability, minimal space, fast time-to-result is required.

2. Background: NAMRU SOUTH has been awarded with CDC Influenza Division funding to continue working in an important field or research related to Influenza and COVID-19 diseases as well as related to the measures to prevent and control their transmission specifically in target risk groups like for instance health care workers. There is enough evidence showing that besides health care personnel frequently receive annual influenza vaccination, a substantive proportion of them might have attenuated or no response to additional standard dose influenza vaccines. In contrast, other studies have shown a significantly improved immunogenicity and seroconversion among adults who received Adjuvanted influenza vaccine (AD) when compare with a non-adjuvanted standard dose vaccine (SD). Then, in health care workers that are seasonally exposed to influenza illnesses and repeatedly vaccinated using standard dose vaccines, adjuvanted influenza vaccines might elicit a better immunity than the typically used standard dose vaccines. Therefore, NAMRU SOUTH together with US CDC is conducting this ongoing study cohort to assess the effectiveness of influenzas vaccine in health care workers. As part of this effort, the surveillance activities included are important to support a regular systematic COVID-19 testing with ongoing repeated assessment of exposure and risk factors to know what the other respiratory viruses are that co-circulate during influenza season and could affect this important target population in the context of the current pandemic. NAMRU SOUTH is leading this effort and is in charge of the study implementation and execution in all the study sites.

3. General Requirements: The requested Fast-16™ mini portable PCR machines must be delivered in a timely manner following submission of the contract, and before the end of FY24.

Delivery must be executed by air, due to the delicate nature of the instruments to our DPO address in Washington DC.

4. Performance Requirements: Timely communication must be maintained until all materials are delivered. If the requested materials cannot be delivered in a timely manner, notification of the delay in delivery, the reason for the delay, and an estimated time of delivery must be provided.

5. Deliverables: The Fast-16™ mini portable PCR machines specifically listed and requested must be delivered in a timely manner and in good condition, according to the delivery specifications of each item with respect to shipping temperature.

6. Special Requirements: N/A

7. Task Orders: N/A