Fentanyl Immunoassay Reagent Test Kits (FDA Approved)

The Naval Medical Readiness Logistics Command intends to issue a full and open solicitation for the purchase of U.S. Food and Drug Administration (FDA) approved fentanyl immunoassay (IA) drug testing reagent kits for detection in human urine samples in support of the Department of Defense (DoD) Drug Demand Reduction Program (DDRP). General Requirements. The kits will be used as the initial (screen) IA for the detection of fentanyl in urine when present (and FDA approved) at a concentration equal to or greater than 1 ng/mL. Without modification of the instrumentation, the reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry analyzers (purchased from Siemens Healthcare Diagnostics). The Government analyzer will be calibrated at 1 ng/mL using DoD prepared and certified solutions containing fentanyl. The IA is limited to a two (2) reagent assay procedure. Reagents which require a separate pre-treatment of each specimen prior to testing on the analyzer are

not considered acceptable. The reagent shall be compatible with the optimal throughput of the analyzer systems and shall not interfere with the optimum performance of the other immunoassay procedures performed on these instruments. The reagent shall not impose additional maintenance, servicing, or calibration requirements for the optimum performance of the proposed reagent on the analyzer. Immunoassay kits shall have clearance from the FDA in order to meet the requirements of DoDI 1010.16 Rev. (June 15, 2020).Interested offerors shall be the Original Equipment Manufacturer (OEM) of reagents, authorized dealer, authorized distributor or authorized reseller for the proposed reagents such that OEM parameters, quality controls and services are provided and maintained by the OEM. All storage, shelf life, and expiration dates associated with the reagents shall be in accordance with the OEM terms and conditions. Repackaging or relabeling of an OEM’s reagents product is prohibited unless otherwise authorized by the OEM.The Product Code is 6550, the North American Industrial Classification System (NAICS) Code is 325413. The small business size standard is 1,250 employees.The solicitation will result in a single award IDIQ contract to provide fentanyl testing reagents for various (6) toxicology laboratories on an as needed basis; quantities needed will be placed via individual delivery orders, shipment to the requesting facility will be identified in each delivery order. DDRP estimates ordering the number of kits, as needed, to perform up to 500,000 tests monthly (inclusive of all 6 laboratories). The guaranteed minimum order under the resulting IDIQ is 100 kits.The proposed contract action has an anticipated ordering/performance period from 01 Nov 2023 through 31 Oct 2026.