The United States Air Force, AFLCMC/Operational Contracting Division, Wright-Patterson AFB, Ohio 45433-5344. This is a Sole Source synopsis published for informational purposes only. This proposed action is for the procurement of ten (10) Helicobacter Pylori Specific Antigen (HSPA) Premier Platinum Plus Kits. The government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1.

This proposed procurement will be a Sole Source under North American Industry Classification System Code (NAICS) 325413. Size standard is 500 employees.

The Meridian Bioscience HPSA Premier Platinum Plus Kits are the only known item that satisfies the critical requirements.
The required specifications for the kits:
All reagents and consumables needed on annual basis

1. Antibody Coated Microwells
2. Positive Control
3. Sample Diluent/Negative Control
4. Premier 20X Wash Buffer I
5. Enzyme Conjugate
6. Premier Substrate I
7. Premier Stop Solution I
8. Transfer Pipettes
9. Microwell Strip Holder
10. Microwell Strip Sealer
11. Wooden Stick Applicators

Reagent and Consumables must contain at a minimum:

• All reagents are all inclusive within each kit purchased. (See list above)
• All reagent kits must be FDA-approved and will exhibit at least 95% sensitivity and 95% specificity.
• Upon request, sufficient reagents shall be provided by the vendor for in-house evaluation of each analyte.
• Following evaluation, each test kit should exhibit at least 95% agreement with the test kits currently in use in the Immunodiagnostics Laboratory.
• The vendor will provide all. The vendor will be the sole manufacturer and distributor of the test kits.
• The vendor shall comply with all FDA regulations, the College of American Pathologist (CAP) checklist dated 4 Jan 2012.

This notice of intent is not a request for competitive quotations. However, all responsible sources may submit a capability statement, proposal, quotation or exception to the intent to purchase on a sole source basis, which shall be considered by the Government if received within two (2) days of this notice. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

The Department of Defense (DoD) has determined the System for Award Management (SAM) to be the single DoD registration for contractors who conduct business or who are interested in conducting business with the DoD. Contractors must be registered in SAM prior to award for solicitations issued after 21 May 1998. You may contact SAM at 1-866-606-8220. SAM website: http://www.sam.gov.

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