N0018926RB011 - Drug Demand Reduction Program, Fentanyl/Norfentanyl Immunoassay Reagent Kits

ESSENTIAL CHARACTERISTICS FENTANYL/NORFENTANYL IMMUNOASSAY REAGENT KITS The Department of War (DoW) Drug Demand Reduction Program (DDRP) has a requirement for Food & Drug Administration (FDA) and Quality Management Documented Fentanyl/Norfentanyl Immunoassay Reagent Kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting fentanyl/norfentanyl in human urine samples. Proposals shall comply with the Statement of Work (SOW). The reagent kits are required for an ordering period of five (5) years. The estimated number of tests shall accommodate up to 500,000 tests per month. Only offerors that are an Original Equipment Manufacturer (OEM) of reagents, or an 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, will be considered for an award. All storage, shelf-life, and expiration dates associated with the reagents shall be in accordance with the OEM terms and conditions, as specified in the SOW. The OEM’s reagent product shall not be repackaged by the Offeror unless authorized, as specified in the SOW. The Offeror shall comply with the FDA and ISO or Quality Assurance documentation, as specified in the SOW. The Offeror and the proposed reagent kit shall comply with the entire SOW. The Offeror shall comply with the Reagent Preparation and Calibration Information, as specified in the SOW. STATEMENT OF WORK 1. GENERAL REQUIREMENTS FOR AN IMMUNOASSAY TEST REAGENT FOR THE DETECTION OF FENTANYL IN URINE. NOTE: The Offeror shall be an Original Equipment Manufacturer (OEM) of reagents, or an 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. Offeror shall not repackage or relabel an OEM’s reagent product unless authorized. 1.1. Scope. The materials shall be for the initial (screen) immunoassay for the detection of fentanyl in urine when present 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 (hereafter referred to as “analyzer”) purchased from Siemens Healthcare Diagnostics in use at the Department of War (DoW) Forensic Toxicology Drug Testing Laboratories (FTDTLs) to include the Armed Forces Medical Examiner System (AFMES) Forensic Toxicology Division. The immunoassay is limited to a two (2) reagent assay procedure. A vendor’s reagent proposal which requires a separate pre-treatment of each specimen prior to testing on the analyzer will not be 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 contractor’s 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). 1.2. Sensitivity and Specificity. The analyzer will be calibrated at 1 ng/mL using DoW FTDTL-prepared and - certified solutions containing fentanyl. All controls, DoW FTDTL-prepared and -certified, shall utilize the same -- 1 of 6 -- compound as the calibrator. The reagent shall minimize cross-reactivity with structurally similar drugs/metabolites in addition to all drugs and metabolites on the current DoW drug testing panel as listed below (excluding the compound of interest). The reagent shall demonstrate calibration stability, as evaluated by frequency of control failures, and shall require calibration no more than once per 8-hour testing period. The following drug cutoffs are currently used by DoW for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively: Drug Class Drugs/Metabolites (IA target in bold) Initial Screen (ng/mL) Confirmation (ng/mL) Marijuana 11-nor-delta-9-THC-carboxylic acid& 11-nor-delta-8- THC-carboxylic acid 50 15 Cocaine Benzoylecgonine 150 100 Opioids Morphine 300 2000 100 100 4000 Codeine 2000 Hydrocodone 100 Hydromorphone 100 Heroin 6-Acetylmorphine 10 10 Opioids Oxycodone & Oxymorphone 100 100 Amphetamines d-Amphetamine & d-Methamphetamine 500 100 Designer Amphetamines Methylenedioxymethamphetamine & Methylenedioxyamphetamine 500 500 Benzo- diazepines Nordiazepam, Oxazepam, Temazepam, Lorazepam, Alpha-hydroxyalprazolam 200 100 Synthetic Cannabinoids 4MBUT, 4MBTN, 5FADB, 5MPCA, ADBTN, ABFUB, M4PIN, MFUBN 10 1 Fentanyl Fentanyl & Norfentanyl 1 1 Lysergic Acid Diethylamide Lysergic Acid Diethylamide & 2-oxo-3-hydroxy-LSD 0.5 0.2 1.3. Compliance with Food & Drug Administration (FDA) Requirements. 1.3.1 Immunoassay kits are considered medical devices and shall have clearance from the FDA to be marketed. The registration and listing process specified by the FDA shall be followed and the manufacturer shall adhere to good manufacturing processes in the manufacture of the devices. Any mandatory recalls of the kits provided under the resulting contract and any other problems that require notification to the FDA shall be resolved as required by the FDA regulations current at the time. The contractor shall notify the Contracting Officer of any recall or FDA notification within two business days of the event. 1.3.2. Except as provided herein, the reagents supplied throughout the term of this contract shall be identical to the reagents offered by the contractor and accepted by the Government at the time of the contract award. If, during the course of this…