Attachment_1_Statement_of_Work.pdf

Statement of Work

IN SUPPORT OF

Luminex Reagent Kits

FOR USAFSAM/PHE

WRIGHT-PATTERSON AFB, OH

Objective/Scope:

The United States Air Force School of Aerospace Medicine Epidemiology Laboratory (USAFSAM /PHE) is seeking an Indefinite Delivery Indefinite Quantity (IDIQ) contract to procure 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.

Background:

Reagents listed in #1 are the specific reagents that are required to function IAW federal FDA regulations on the Luminex Magpix instrument to produce required respiratory patient testing for

USAFSAM/PHE

Minimum Requirements:

The contractor will provide the following:

1. The vendor will provide these reagents:

Reagent/Kit Name Material Number Annual

Quantity Description

RPP NXTAG (IVD-US) 96 Tests

I051C0447 116 Kit

MAGPIX Calibration Kit, 25 Uses, IVD

MPXIVD-CAL-K25

13 Kit

MAGPIX Drive Fluid 4PK, IE, IVD

MPXDF-4PK-1

15 Kit

MAGPIX Performance Verification Kit, 25 Uses, IVD

MPXIVD-PVER-K25

12 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.