65 -- D-METHAMPHETAMINE AND DESIGNER AMPHETAMINE REAGENT (MDMA & MDA)

Notice Date

August 8, 2001

Contracting Office

Naval Medical Logistics Command, Code 02, 1681 Nelson Street, Ft. Detrick, MD 21702-9203

ZIP Code

21702-9203

Solicitation Number

N62645-01-R-0008

Response Due

August 31, 2001

Point of Contact

Ralph Payne 301-619-3026

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. The Request for Proposal number is N62645-01-R-0008. Provisions and clauses in effect through Federal Acquisition Circular 97-27 are incorporated. NAICS 325413/SIC 2835. Naval Medical Logistics Command has the following requirement for immunoassay reagent for d-Methamphetamines and Designer Amphetamines (MDMA and MDA) for use in the DoD Military Drug Testing Laboratories. The resulting contract will be a requirements type contract with a base year (CLIN 0001) and four option years (CLINS 0002-0005). The estimated number of tests per year is 3.6 million. SOW. C.1. REQUIREMENTS FOR IMMUNOASSAY TEST REAGENT FOR d-METHAMPHETAMINE and DESIGNER AMPHETAMINES. C.1.1. The materials shall be for the immunoassay of d-methamphetamine and designer amphetamines (MDMA and MDA) in urine and is to provide immunologic reagent for initial (screen) testing. The reagent must provide equivalent or better performance characteristics of sensitivity and specificity for detection of the methamphetamine, and better performance characteristics of sensitivity and specificity for detection of MDMA in urine as the current immunoassay procedure employed in the military laboratories. The reagent must possess broad cross-reactivity to methamphetamine analogues in order to maximize sensitivity to designer amphetamines when present at a concentration greater than 500 ng/mL of urine. Cross reactivity with d-amphetamine is desirable for the detection of d-amphetamine abuse. The reagent must be compatible for use with the Roche Chemical Analyzer Systems (DDP, DPP, DP/PP) and must be applicable without modification of the equipment. The reagent must be compatible with the optimal throughput of the Roche Chemical Analyzer Systems (DDP, DPP, DP/PP) and must not interfere with the optimum performance of the other immunoassay procedures performed on the instrument. C.1.2. Sensitivity and Specificity. The reagent shall be used for the identification of d-methamphetamine and designer amphetamines (MDMA and MDA) associated with drug abuse in physiological urine specimens. The reagent must provide equivalent or better performance characteristics in terms of sensitivity and specificity for detection of d-methamphetamine, and better performance characteristics in of sensitivity and specificity for the detection of MDMA in urine as the current immunoassay procedure used in the military laboratories. Recognizing that physiologic urine specimens from d-methamphetamine drug use may contain other by products of synthesis, the sensitivity and specificity of the assay should maximize the antibody cross-reactivity to d-methamphetamine and the designer amphetamines (MDMA and MDA) when present at a concentration equal to or greater than 500 ng/mL of urine. The immunoassay reagent must minimize the cross-reactivity with other pharmacological drugs or metabolites commonly associated with cold medication containing ephedrine, pseudoephedrine, and phenylpropanolamine. The immunoassay reagent must minimize cross-reactivity with the drugs or drug metabolites listed in the table below. Cross reactivity with d-amphetamine is desirable for the detection of d-amphetamine abuse. DoD laboratory certified solutions of pure d-methamphetamine at a concentration of 500 ng/mL will be used for calibration of the Roche Chemical Analyzer Systems (DDP, DPP, DP/PP). The testing reagent must detect better than 95% of all quality control specimens containing d-methamphetamine at concentrations equal to or greater than 125% of the DoD cutoff concentration of 500 ng/mL. The d-methamphetamine immunoassay reagent must also maintain reproducibility in quality control (QC) and quality assurance (QA) measurements. The following drug cutoffs (in ng/mL) in urine specimens are currently used by the DoD for the initial immunoassay and GC/MS confirmation tests. 11 Nor delta 9 THC carboxylic acid (THCCOOH), 50, 15; Cocaine (Benzoylecgonine), 150, 100; Opiates (Morphine), 2000, morphine 4000, codeine 2000; Phencyclidine (PCP), 25, 25,; Amphetamine/Methamphetamine, 500, 500; Barbiturates (secobarbital), 200, 200; Lysergic acid diethylamide (LSD), 0.5, 0.2. C.1.3. Compliance with Food & Drug Administration (FDA) Requirements. C.1.3.1. Immunoassay kits are medical devices and must have clearance from the Food and Drug Administration (FDA) to be marketed. The registration and listing process specified by the FDA must be followed and the manufacturer must adhere to good manufacturing processes (GMP) in the manufacture of the devices. Any mandatory recalls of the kits provided under this contract and any other problems that require notification to the FDA must 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. C.1.4. The materials provided must be in volumes and packaging, which are convenient and applicable to the throughput of the military laboratories and should not result in the loss or unnecessary disposal of more than 3% of the working volume of reagent. Any individual bottle of reagent which would be prepared for use at one time may not include materials for more than 3,000 tests. The contractor will not be required to provide calibrators and control materials for the drug reagent. (The military laboratories will separately obtain or provide calibrators and control materials to be used with the reagent.) The materials must 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 optimized for military drug testing laboratory operations as represented in these specifications and cutoffs as utilized by the DoD. The Government will not develop procedures or optimize the performance of a kit for the contractor. C.1.5. Shelf life. Minimum shelf life of any unopened component of the assay shall be at least 180 days from date of delivery at the drug testing laboratory. Once kit container seals are broken and the component opened, the shelf-life must be at least 14 days. Once diluted the material must have a shelf life of at least 24 hours. C.2. TESTING and QUALITY CONTROL PROTOCOL. The following testing and quality control protocol will be used for all military testing. The reagents supplied must be adaptable to the calibration requirements and characteristics of the Roche Chemical Analyzer Systems (DDP, DPP, DP/PP). Verification of each calibration will be accomplished with a drug free control, a control at 75% of cutoff concentration, a control at 125% of cutoff concentration and a control at 200% of cutoff concentration. An acceptable verification will have analytical readings for the drug free <75% <cutoff <125% <200% controls. Open and blind quality control urine will be distributed throughout a test batch and will make up about 10% of the number of total specimens. The reagent must meet the performance criteria outlined in C.1.2 and C.3.1 using this testing protocol. C.3. CHARACTERISTICS OF d-METHAMPHETAMINE and DESIGNER AMPHETAMINES REAGENT. C.3.1. The reagent shall identify specimens containing d-methamphetamine and the designer amphetamines (MDMA and MDA) in human physiological urine. Cross reactivity with d-amphetamine is desirable for the detection of d-amphetamine abuse. The assay shall identify as positive by the initial test better than 95% of the quality control specimens that contain 625 ng/mL or more of d-methamphetamine used as a control material. The testing reagent must be specific for d-methamphetamine and the designer amphetamines MDMA and MDA such that better than 95% of the actual human physiological test specimens containing d-methamphetamine and/or the designer amphetamines (MDMA and MDA) identified as positive by the current immunoassay and GC/MS procedures employed in the military laboratories will be identified as positive by the offeror's immunoassay reagent on the Roche Chemical Analyzer Systems. The reagent must also minimize the number of "false positive" screens requiring GC/MS confirmatory analysis due to the presence of cold medications containing ephedrine, pseudoephedrine or phenylpropanolamine. Cross reactivity with l-methamphetamine and l-amphetamine should be minimized. Better than 80% of the specimens identified as presumptive positive by the offer's screening reagent must confirm for the presence of d-methamphetamine, d-amphetamine, or the designer amphetamines of MDMA and MDA at or above the GC/MS confirmation cutoff of 500 ng/mL by the procedures used in the military laboratory. A specimen is considered to be a "false positive" screen if GC/MS fails to detect the presence of d-methamphetamine, d-amphetamine or the designer amphetamines MDMA and MDA at the levels of quantitation of the instrumentation as defined in the military drug laboratories. The reagent shall demonstrate linearity for total d-methamphetamine to 250% of the DoD immunoassay cutoff concentration. C.3.2. An assay of 100 sequential aliquots of each of the following quality control samples using the reagent must correctly identify better than 95% of the 75% controls as negative and 125% controls as positive. The coefficient of variation for the calibrators, and controls at concentrations of 75%, 125% and 200% of the calibrator, must be less than 7.5%. A batch will consist of 250-300 samples tested between verifications of calibration. Throughout the batch there must not be significant drift in control values. C.3.3. Better than 95% of the open low concentration quality control samples (75% of the 500 ng/mL d-methamphetamine immunoassay cutoff) must produce negative results in each analytical run and as calculated on a weekly basis. C.3.4. Better than 95% of the open positive quality control samples (125% of the 500-ng/mL d-methamphetamine immunoassay cutoff) must be identified as positive in each analytical run and as calculated on a weekly basis. C.3.5. An assay of 20 sequential controls containing drug at 200% of the cutoff concentration must all screen positive and have a coefficient of variation of the mean concentration reading less than 7.5%. C.3.6. Each immunological reagent shall be checked for cross reactivity to other illicit or pharmacological abused drugs, chemicals, or metabolites that might produce a false positive response. C.3.7. The immunological reagent shall be checked for cross-reactivity to each drug/metabolite listed in C.1.2. The reagent must not give a positive assay result for any of the drug/metabolites listed from any of the other six drug classes when they are in concentrations at 100 times the screening cutoff concentration or the solubility limit of the drug in urine, whichever is less. C.3.8. The contractor must provide upon request 250 ml of drug free (free of amphetamines, LSD, THCCOOH, benzoylecgonine, cocaine, barbiturates, PCP, and opiates, and must also contain less than 20 ng/mL of benzodiazepines) urine with each reagent kit order (equivalent to 2,000 tests/reagent kit). The drug free urine provided with the reagent must have a GC/MS drug concentration less than the limit of quantitation for the analyte methodologies. In addition, immunoassay of the drug free urine should have a semi-quantitative concentration readings equivalent to or less than those recorded for drug controls at 20% of the DoD immunoassay cutoff concentrations. The negative urine should not be sent automatically. If a laboratory request negative urine, it may be shipped with the monthly reagent delivery and supplied in 1 liter volume containers. The military laboratories can not redeem or exchange unused allocations of negative urine accrued by reagent purchase for additional reagents or other supplies from the vendor. C.4. QUALITY ASSURANCE PROGRAM OF THE MANUFACTURING PROCESS SHALL INCLUDE THE FOLLOWING ELEMENTS. C.4.1. Chemicals and Reagents C.4.1.1. Quality and authenticity. All materials used in the preparation of reagents should be verified as to authenticity and purity. Methods may include, but are not limited to, the determination of melting points, and GC/MS, Nuclear Magnetic Resonance (NMR), and spectrophotometric measurements. C.4.1.2. Stability. The kit and each kit component must be shown to be stable and at the correct concentration over the period of use of the kit. Components that are homogeneous solutions must not deteriorate throughout the period of use of the kit (from date of preparation to date of expiration). C.4.2. Manufacturers Equipment. C.4.2.1. Preventive maintenance. Routine preventive maintenance procedures, periodic calibration, and any unscheduled maintenance must be fully documented and in accord with recommendations of the manufacturer of the equipment. C.4.2.2. Calibration and operational checks. All instruments that are used to check a physical parameter of a solution or material must be calibrated and have documentation available to demonstrate that all required operational checks have been completed. This includes gamma counters, pH meters, spectrometers, micropipettes, etc. C.4.2.3. Temperature checks. Water baths, refrigerators, freezers, and other equipment that maintains a given temperature must be periodically validated for accuracy and routinely verified for correct settings. C.4.2.4. Glassware and other reusable laboratory supplies. Appropriate procedures for cleaning and inspecting glassware and other reusable materials must be established and compliance documented. C.4.3. Antibody Drug Molecule. C.4.3.1. Authenticity. The prepared antibody drug molecule must be verified to be authentic and its purity established. C.4.3.2. Stability. The antibody drug must be documented to be stable to the expiration date and the immunoassay must meet all contract specifications to the end of expiration date (which is 180 days minimum). C.4.4. Antibody specificity. Antibody specificity must be verified for each lot and the specificity reevaluated at routine intervals to ensure uniformity and quality of preparations. The reagent must provide equivalent or better performance characteristics in terms of sensitivity and specificity for detection of d-methamphetamine and designer amphetamines (MDMA and MDA)in urine as the current immunoassay procedure used in the military laboratories. The number of "false positive" screens requiring GC/MS confirmatory analysis due to the presence of cold medications containing ephedrine, pseudoephedrine, or phenylpropanolamine must be minimized. Cross reactivity with l-amphetamine and l-methamphetamine must also be minimized. Better than 80% of the specimens identified as presumptive positive by the offer's screening reagent must confirm for the presence of d-methamphetamine and designer amphetamines (MDMA and MDA) equal to or above 500 ng/mL by the GC/MS procedure in the military laboratory. The d-methamphetamine immunoassay reagent must be specific for d-methamphetamine, d-amphetamine, and designer amphetamines (MDMA and MDA) such that better than 95% of the actual human physiological test specimens containing d-methamphetamine, d-amphetamine, and designer amphetamines and identified as positive by the current immunoassay and GC/MS procedures employed in the military laboratories will be identified as positive by the offer's immunoassay reagent on the Roche Chemical Analyzer Systems (DDP, DPP, DP/PP). Cross reactivity with d-amphetamine is desirable for the detection of d-amphetamine abuse. The reagent shall demonstrate linearity for d-methamphetamine quantitation to 250% of the DoD immunoassay cutoff concentration. Chemical compounds that may reasonably be found in urine resulting from prescription or non-prescription drug use must be tested to characterize antibody specificity. Specificity testing will include biochemical materials produced normally in the human body (this may be evaluated by testing numbers of specimens of normal human urine). C.4.5. Immunoassays. C.4.5.1. Technical performance. Performance of each lot of kits must be verified. The verification must establish, as a minimum, the appropriate response to the target molecule and that all other parameters as specified in the contract is met. C.4.5.2. Stability. The performance parameters involved in the testing procedures must be verified and documented to be consistent throughout the shelf life of the kit. C.4.5.3. 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 must be described in detail. All steps of each quality control procedure shall be described thoroughly. C.4.5.4. Records. The production and quality assurance records generated by each procedure performed above must be maintained in a systematic fashion to permit the verification of completion of all production parameters and shall be available for inspection during the term of the contract. C.4.5.5. Corrective action. When a specified quality control parameter is found to be out of control limits, the action taken to ensure correction for existing kits (i.e., notification) must be documented and action taken to ensure that the deficiency does not reoccur and all records must be retained. The Contracting Officer must be notified within 2 working days of any deficiencies in existing kits and of all corrective actions. The FDA must be notified according to its regulations. C.4.5.6. Lot numbers. Lot numbers must be used to identify reagent and other preparations to allow tracking of all immunoassay components. The procedures used to assign unique lot numbers for each solution or reagent must be described. A single lot number for a kit will 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. The provisions at FAR 52.212-1, Instructions to Offerors-Commercial Items apply with the exception of (d), (f), (h) and (i), which are reserved. FAR 52.212-2, Evaluation-Commercial Items is not applicable. The following Proposal Instructions and Evaluation Factors will be used. 1. INSTRUCTIONS FOR PREPARATION OF PROPOSALS. Offerors must submit a comprehensive proposal. Information provided should be precise, factual and complete. Any proposal that does not offer as a minimum, that which is requested, may be determined to be substantially incomplete and not warrant any further consideration. The Government will award a contract to the responsible offeror whose offer will be most advantageous to the Government, price and other factors considered. 1a. Business Proposals must be submitted in an original and one (1) copy and MUST INCLUDE THE FOLLOWING: 1a(1). Proposed prices will be provided with offerors submitting a per test price based on the estimated number of tests stated above for CLIN 0001 through 0006. 1a(2). Offerors shall state the total number of tests per kit proposed. The number of tests shall be based on the reagent volume recommended by the equipment manufacturer. 1a(3). Offerors shall provide an order and delivery schedule. The proposed schedule will include Order Dates (latest date order can be placed), and Order Delivery Dates (date orders will be delivered). 1(b). Technical Proposals must be subm

Record

Loren Data Corp. 20010810/65SOL009.HTM (W-220 SN50U339)