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The Department of Defense (DoD) Drug Demand Reduction Program (DDRP) has a requirement for FDA and Quality Management Documented 6-acetylmorphine Immunoassay Reagent Kits for use with the currently in... The Department of Defense (DoD) Drug Demand Reduction Program (DDRP) has a requirement for FDA and Quality Management Documented 6-acetylmorphine Immunoassay Reagent Kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting 6-acetylmorphine in human urine samples. Proposals shall comply with the Statement of Work (SOW). The reagent kits are required for a period of performance (PoP) of five (5) years. The estimated number of tests shall accommodate up to 500,000 tests per month. Only 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, will be considered. 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 vendor shall comply with the FDA and Quality Management Documentation, as specified in the SOW. The vendor shall comply with the Reagent Preparation and Calibration Information, as specified in the SOW. 1.1. Scope. The materials shall be for the initial (screen) immunoassay for the detection of 6-acetylmorphine (6AM) in urine when present at a concentration equal to or greater than 10 ng/mL The reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers (hereafter referred to as “analyzer”) in use at the Department of Defense (DOD) Forensic Toxicology Drug Testing Laboratories (FTDTLs), to include the Armed Forces Medical Examiner System (AFMES) Forensic Toxicology Division, without modification of the equipment. The immunoassay procedure is limited to a two reagent assay procedure. A vendor’s reagent proposal which requires a separate pretreatment of each testing 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). Immunoassay kits will be evaluated based on their ability to accurately detect 6AM based on the testing and performance characteristics in conjuncture with all evaluation factors. 1.2. Sensitivity and Specificity. The analyzer shall be calibrated at 10 ng/mL using DOD FTDTL prepared and certified solutions containing 6-AM. The controls will utilize the same compound as the calibrator. The reagent shall minimize cross-reactivity with structurally similar drugs/metabolites in addition to the drugs/metabolites on the current DOD drug testing panel, 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 one time during an 8 hour period. The following drug cutoffs are currently used by DOD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively. 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 working 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 contract, the manufacturer wishes to change or improve its kit, that product modification shall be proposed in writing to the Contracting Officer for approval prior to its incorporation into the kits to be delivered. The contractor's proposal shall include documentation that demonstrates that the manufacturer has complied with all applicable FDA regulations, including those concerning the filing of a new 510k notice if such action and subsequent FDA clearance are warranted by the nature of the modification. 1.4. Packaging. The reagents provided shall be in volumes and packaging that are convenient and applicable to the sample throughput at the FTDTLs and shall not result in the loss or unnecessary disposal of more than 3% of the working volume of reagent. The contractor shall not be required to provide calibrators/controls. The reagents shall be provided with an instruction sheet that complies with all requirements of the FDA and includes data demonstrating specific performance characteristics, such as accuracy, precision, sensitivity, specificity, cross-reactivity, and safety precautions. The instruction sheet(s) shall include procedures and instrument parameters optimized for FTDTL operations as represented in these specifications and cutoffs as utilized by the DOD. The Government shall not develop procedures or optimize the performance of a kit for the contractor. Offeror shall not repackage or relabel an OEM product unless authorized. 1.5. Shelf Life. The minimum shelf life of any unopened component of the assay shall be at least 180 days from the date of delivery to the FTDTL. All storage, shelf life, and expiration dates associated with the reagents shall be in accordance with the OEM terms and conditions. Once kit container seals are broken and the components are opened, the shelf-life shall be at least 14 days. 1.6. The FTDTLs intend to use the immunoassay kits in a manner consistent with the FDA approval. The package insert and information for the analyzer settings must contain the information necessary for the FTDTLs to use the immunoassay kits consistent with the device’s FDA approval. This ensures that the FTDTLs can use the immunoassay kits properly and derive the full benefit of the FDA approval. 2. TESTING and QUALITY CONTROL PROTOCOL. 2.1. The reagents supplied shall be compatible with the calibration requirements and characteristics of the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers. Verification of each calibration, at 10 ng/mL, shall be accomplished with a drug free control and open controls at target concentrations of 50-75% and 150-200% of the calibrator/cutoff. An acceptable verification will have analytical readings as follows: drug free control < 50-75% control < cutoff (calibrator) < 150-200% control. The batch may also contain blind negative and positive controls distributed throughout the batch. 3. PERFORMANCE CHARACTERISTICS. 3.1. The reagent shall be capable of identifying specimens as positive for 6AM when present in human urine at concentrations equal to or greater than 10 ng/mL as determined by the current immunoassay and gas chromatography-mass spectrometry (GC-MS) or liquid chromatography- tandem mass spectrometry (LC-MS/MS) procedures utilized in the FTDTLs (and AFMES). 3.2. The reagent shall be capable of identifying specimens as negative for 6AM when present in human urine at concentrations below 10 ng/mL as determined by the current immunoassay and GC-MS or LC-MS/MS procedures utilized in the FTDTLs (and AFMES). 3.3. The reagent performance, as evaluated through the performance of controls, shall be stable over the course of the day and shall not require re-calibration within an eight hour period. 3.4. The reagent shall display precision and accuracy both within and between batches for concentrations ranging between 50-200% of the calibrator concentration. 3.5. The reagent shall produce non-overlapping ranges for samples analyzed at 0%, 50%, 100%, 150%, and 200% of the calibrator concentration. 3.6. The reagent shall have minimal cross reactivity with analytes other than 6-AM. 4. QUALITY ASSURANCE PROGRAM OF THE MANUFACTURING PROCESS SHALL POSSESS CURRENT ISO-9000 SERIES CERTIFICATION, CURRENT ISO 13485 SERIES OR INCLUDE DOCUMENTATION OF THE FOLLOWING ELEMENTS: 4.1. Chemicals and Reagents 4.1.1. Quality and Authenticity. All materials used in the preparation of reagents shall be verified as to authenticity and purity. Methods may include, but are not limited to, the determination of melting points, GC-MS, Nuclear Magnetic Resonance, and spectrophotometric measurements. 4.1.2. Stability. The kit and each kit component shall be shown to be stable and at the correct concentration over the period of use. Components that are homogeneous solutions shall not deteriorate throughout the period of use of the kit (from date of preparation to date of expiration). 4.2. Manufacturer’s Equipment 4.2.1. Preventative maintenance. Routine preventive maintenance procedures, periodic calibration, and any unscheduled maintenance shall be fully documented and in accordance with recommendations of the manufacturer of the equipment. 4.2.2. Calibration and operational checks. All instruments that are used to check a physical parameter of a solution or material shall be calibrated and have documentation available to demonstrate that all required operational checks have been completed. This includes pH meters, spectrometers, micropipettes, etc. 4.2.3. Temperature Checks. Water baths, refrigerators, freezers, and other equipment that is intended to maintain a given temperature shall be periodically validated for accuracy and routinely verified for correct settings. 4.2.4. Glassware and other reusable supplies. Appropriate procedures for cleaning and inspecting glassware and other reusable materials shall be established and compliance documented. 4.3. Antibody 4.3.1. Authenticity. The prepared antibody shall be verified to be authentic and its purity established. 4.3.2. Stability. The antibody shall be documented to be stable to the expiration date and the immunoassay shall meet all contract specifications to the end of expiration date (a minimum of 180 days from date of delivery to FTDTL/AFMES). 4.3.3. Specificity. Antibody specificity shall be verified for each lot and the specificity re-evaluated at routine intervals to ensure uniformity and quality of preparations. The reagent shall provide performance characteristics in terms of sensitivity and specificity for detection of 6AM in urine. Chemical compounds that may reasonably be found in urine resulting from prescription or non-prescription drug use shall be tested to characterize antibody specificity. Specificity testing may include biochemical materials produced normally in the human body. 4.4. Immunoassays 4.4.1. Technical Performance. Performance of each lot of reagent shall be verified. The verification shall establish, as a minimum, the appropriate response to the target molecules and that all other parameters as specified in the contract are met. The performance parameters involved in the testing procedures shall be verified and documented to be consistent throughout the shelf life of the kit. 4.4.2. Manufacturer’s production manual. Procedures and criteria required to validate all components (and materials) employed during the manufacture of the reagents in the test kits and the operation of the completed kit over the entire period of shelf-life of the kit shall be described in detail. All steps of each quality control procedure shall be described thoroughly. 4.4.3. Records. The production and quality control records generated by each procedure performed above shall be maintained in a systematic fashion to permit the verification of the completion of all production parameters and shall be available for inspection during the term of the contract. 4.4.4. Corrective action. When a specified quality control parameter is found to be out of limits, the action taken to ensure correction for existing kits (i.e., notification) shall be documented and action taken to ensure that the deficiency does not reoccur. All records shall be retained. The Contracting Officer shall be notified within 2 working days of any deficiencies in existing kits and of all corrective actions for consideration, i.e., delivery of replacement kits at no cost to the Government. The FDA shall be notified according to its regulations. 4.4.5. Lot numbers. Lot numbers shall be used to identify reagents to allow tracking of all immunoassay components. The procedures used to assign unique lot numbers for each solution or reagent shall be described. A single lot number for a kit shall suffice if all materials used in that lot number can be tracked to identify the materials and procedures used in the preparation of that kit. 5. PACKAGING AND MARKING. 5.1. Thermal Protection for Biologic Reagents. The contractor shall ship biologic reagent items used in the reagent kits in insulated thermal containers to ensure protection of the reagents against thermal (heat and cold) damage which would affect reagent performance contained in the Statement of Work of this contract. 5.2. Marking of Shipments (Commercially-Packaged Items). Marking shall be in accordance with ASTM D 3951 15, "Standard Practice for Commercial Packaging." 5.2.1. Additional markings include: Contract Number & Government Delivery Order Number. 5.3. Deteriorative Material Marking. The contractor shall include as part of the marking, the following information: (a) Expiration date; (b) Required storage conditions for each kit component; and (c) Type I or Type II shelf life date as specified in MIL-STD-129 for each unit of material, issue, package, intermediate container and exterior shipping container.