SOW_Luminex.pdf

Statement of Work

Luminex Reagent Kits

FOR USAFSAM/PHE

WRIGHT-PATTERSON AFB, OH

The United States Air Force School of Aerospace Medicine Epidemiology Laboratory Service Division (USAFSAM/PHE) located at Wright-Patterson AFB (WPAFB) requires reagent kits to perform testing for molecular samples to include flu testing. 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.

Delivery Requirement: 2 Weeks After Issue of CALL

Delivery Address:

USAFSAM/PHE

2510 Fifth Street, Area B Facility 20840 Wright-Patterson AFB, OH 45433-7913

Technical Requirements:

1. The vendor shall provide these reagents:

Reagent/Kit Name Material Number

RPP NXTAG (IVD-US) 96 Tests

I051C0447

MAGPIX Calibration Kit, 25 Uses, IVD

MPXIVD-CAL-

K25

MAGPIX Drive Fluid 4PK, IE, IVD

MPXDF-4PK-1

MAGPIX Performance Verification Kit, 25 Uses, IVD

MPXIVD-PVER-

K25

2. Vendor shall provide reagents that are FDA approved to function on the Luminex Magpix instrument, owned by USAFSAM/PHE, and comply with all FDA regulations.

3. Vendor shall supply reagents that have a minimum of 6 months of remaining shelf life upon time of delivery.

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

5. The vendor shall 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 shall provide temperature shipping information upon request.