Attachment_-_Statement_of_Work_Aug_2018.pdf

Statement of Work

IN SUPPORT OF

Luminex Reagent Kits Large Purchase Request

FOR USAFSAM/PHE

WRIGHT-PATTERSON AFB, OH

The United States Air Force School of Aerospace Medicine Epidemiology Laboratory

(USAFSAM /PHE) requires vendor supported reagents/consumables/kits necessary to perform innovative biological testing technologies. These reagents are required for laboratory diagnostic testing support for 224 DoD MTFs and 9.4 million patients/beneficiaries. The laboratory testing is utilized for the diagnosis and patient care for respiratory viruses and bacteria.

USAFSAM/PHE currently owns the Luminex MAGPIX instrument with the capability of testing the reagents the Government requires. For this reason, the reagents are required to function IAW federal FDA regulations and be used on the Luminex MAGPIX instrument to produce required respiratory patient testing. Luminex is the sole manufacturer and distributor of these reagents.

Current Requirements:

The contractor will provide the following:

1. The vendor will provide these reagents:

Reagent/Kit Name Material Number Quantity Description

RPP NXTAG (IVD-US) 96 Tests

I051C0447

Kit

2. Reagents must be FDA approved to function on the Luminex Magpix instrument, owned by

USAFSAM/PHE, and the vendor will comply with all FDA regulations.

3. Reagents must have at least a 6 month expiration date.

4. The vendor will provide technical assistance if reagents do not exhibit at least 95% correlation during lot-to-lot and shipment-to-shipment verifications.

5. The vendor will provide technical assistance and/or replacement of reagents if, due to no fault of the government, reagents fail to function as specified.

6. The vendor shall provide validation support, kits will exhibit at least 95% sensitivity and

95% specificity when validated.

7. The vendor will provide temperature shipping information upon request.