65 -- IMMUNOASSAY REAGENT FOR LSD

Notice Date

December 21, 2001

Contracting Office

Department of the Navy, Bureau of Medicine and Surgery, NMLC, 1681 Nelson St, FT Detrick, MD, 21702-9203

ZIP Code

21702-9203

Solicitation Number

N62645-02-T-0002

Response Due

January 16, 2002

Point of Contact

Ralph Payne, Contracting Officer, Phone 301-619-3026, Fax 301-619-2925, Email repayne@us.med.navy.mil -- Nancy LaVi gne, Contracting Officer, Phone 301-619-3023, Fax 301-619-2925, Email nllavigne@us.med.navy.mil

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplem ented with additional information included in this notice. This announcement constitutes the only solicitation and a writte n solicitation will not be issued. The Request for Quotation number is N62645-02-T-0002. Provisions and clauses in effect through Federal Acquisition Circular 2001-01 are incorporated. NAICS 325413/SIC 2835. The Navy intends to negotiate with M icrogenics Corporation, Freman, CA as the only source that can provide the following immunoassay reagent for lysergic acid d iethylamide (LSD) for use in the DoD Military Drug Testing Laboratories. The resulting contract will be a requirements type contract with a base year and five option years. The estimated quantity of test kits per year is 360. SOW. C.1. REQUIRE MENTS FOR IMMUNOASSAY TEST REAGENT FOR LYSERGIC ACID DIETHYLAMIDE. C.1.1 The materials shall be for the immunological reag ent for initial (screen) testing of lysergic acid diethylamide (LSD) in urine. The reagent must provide equivalent or bette r performance characteristics of sensitivity and specificity for detection of LSD and its metabolites in urine as the curren t immunoassay for LSD employed in the military laboratories. The reagent must be compatible for use with the Roche-Hitachi Modular automated chemical analyzer system, specifically with the P module and/or the DDP for optimal throughput of sample t esting on the Modular system. The reagent must be applicable without modification of the Modular system beyond establishment of operational parameters. The reagent must not interfere with the optimum performance of other immunoassay procedures per formed on the Modular system. C.1.2 Sensitivity and Specificity. The reagent shall be used for the identification of LSD and its metabolites in physiological urine specimens. The reagent must provide equivalent or better performance characteris tics in terms of sensitivity and specificity for detection of LSD and its metabolites in urine as the current LSD immunoassa y screening procedure used in the military laboratories. Recognizing that physiologic urine specimens from LSD drug ingesti on may contain other metabolites of LSD or iso-LSD, the sensitivity and specificity of the assay should maximize the antibod y cross-reactivity for LSD and iso-LSD and their metabolites, such as 2-oxo-3-hydroxy-LSD. The assay must not cross-react w ith other drugs or metabolites listed in the table below. DoD laboratory certified solutions of pure LSD at a concentration of 500 pg/ml will be used for calibration of the Roche-Hitachi Modular system. However, the reagent must perform such that in actual physiological urine specimens containing 150 -- 175 pg/ml of LSD (as determined by gas chromatography-mass spectro metry) in the presence of the various other metabolites from LSD ingestion found in urine, will show an apparent concentrati on of 500 pg/ml total LSD metabolic products by the reagent immunoassay procedure. While LSD is the principal compound for LSD detection, sensitivity to the presence of iso-LSD is required. Sensitivity to LSD and iso-LSD should be maximized. The testing reagent must detect 90% of all quality control specimens containing pure LSD or iso-LSD at concentrations equal to o r greater than 135% of the DoD cutoff concentration of 500 pg/ml. The LSD testing reagent must also maintain reproducibilit y in quality control (QC) and quality assurance (QA) measurements. The following drug cutoffs in urine specimens are curren tly used by the DoD for the initial immunoassay and GC/MS confirmation tests. Drug/Metabolite; Cutoff in ng/mL, Initial test , GC/MS. 11 Nor delta 9 THC carboxylic acid (THCCOOH), 50, 15; Cocaine (Benzoylecgonine), 150, 100; Opiates (Morphine), 200 0, morphine 4000, codeine 2000; Phencyclidine (PCP),25, 25, Amphetamine/ Methamphetamine (amphetamines), 500, 500; Barbitura tes (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 Administr ation (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 pro vided under this contract and any other problems that require notification to the FDA must be resolved as required by the FD A regulations current at the time. The contractor shall notify the Contracting Officer of any recall or FDA notification wi thin two working days of the event. C.1.3.2 Except as provided herein, the reagent supplied throughout the term of this co ntract shall be identical to the reagent offered by the contractor and accepted by the Government at the time of the contrac t award. If, during the course of this contract, the manufacturer wishes to change or improve its kit, that product modific ation must be proposed in writing to the Contracting Officer for approval prior to its incorporation into the kits to be del ivered. The contractor's proposal must include documentation which 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 cl earance are warranted by the nature of the modification. C.1.4 The materials provided must be in volumes and packaging whi ch are convenient and applicable to the throughput of the military laboratories and should not result in the loss or unneces sary disposal of more than 3% of the working volume of reagent. Any individual bottle of reagent which would be prepared fo r use at one time may not include materials for more than 4,000 tests. The contractor will not be required to provide calib rators 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, p recision, sensitivity, specificity, cross-reactivity, and safety precautions. The instruction sheet(s) shall include proced ures optimized for military drug testing laboratory operations as represented in these specifications and cutoffs as utilize d by the DoD. The Government will not develop procedures or optimize the performance of a kit for the contractor. C.1.5 S helf life. Minimum shelf life of any unopened component of the assay shall be at least 180 days from date of delivery at th e drug testing laboratory. Once kit container seals are broken and the component opened, the shelf-life must be at least 14 days. If diluted, the material must have a shelf life of at least 24 hours. C.2 TESTING AND QUALITY CONTROL PROTOCOL. T he following testing and quality control protocol will be used for all military testing. The reagents supplied must be adap table to the calibration requirements and characteristics of the Roche-Hitachi Modular high speed automated analyzer, specif ically the D module. Verification of each calibration will be accomplished with a drug free control, a control at 65% of cu toff concentration, a control at 135% of cutoff concentration and a control at 200% of cutoff concentration. An acceptable verification will have analytical readings for the drug free less than 65% less than cutoff less than 135% less than 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 REAGENT. C.3.1 LSD. The reagent shall identify specimens containing LSD, iso-LSD and its principal human metabolites such as 2-oxo-3-hydroxy-LSD. The assay shall identify as positive by the initial test 90% of the quality control specimens that contain 675 pg/mL or more of LSD. The sensitivity and specificity of the assay should provide sufficient cross-reactivity with the LSD human metabolites such that actual physiological urine specimens which contain 150 -- 175 pg/ml of LSD as determined by gas chromatography-mass spectrometry would show an apparent concentration of 500 pg/ml total LSD metabolic products by the reagent immunoassay procedure. While LSD is the principal compound for LSD detection, sensitivity to the presence of iso-LSD is required. Sensitivity to LSD and iso-LSD should be maximized. The LSD testing reagent must be specific for LSD and its human metabolites such that no less than 90% of the actual test specimens identified as presumptive positive by the current combination of immunoassay and adjunct RIA screening procedures employed in the DoD military laboratories will be identified as positive by the immunoassay reagent on the Roche-Hitachi Modular system P and/or D Module, at the DoD screening cutoff. In addition, the reagent must provide equivalent or better performance characteristics in terms of sensitivity and specificity for detection of LSD and its metabolites in urine as the current immunoassay screening procedures used in the military laboratories. The number of "false positive" screens requiring GC/MS confirmatory analysis shall be minimized. A specimen is considered to be a "false positive" screen if it fails to detect the presence of LSD, or iso-LSD, or other major LSD metabolites at the levels of quantitation of the instrumentation as defined in the military drug laboratories. The reagent shall demonstrate linearity for LSD quantitation to 200% of the DoD immunoassay cutoff concentration. C.3.2 An assay of 20 sequential aliquots of each of the following quality control samples using the reagent must correctly identify 90% of the 65% and 135% of the controls. The coefficient of variation for calibrators, and controls at concentrations of 135% and 200% of the calibrator, must be less than 25%. A batch will consist of the 300 samples tested between verifications of calibration. Throughout the batch there must not be significant drift in control values. C.3.3 A minimum of 90 percent of the open low concentration quality control samples (65 percent of the 500 pg/mL LSD immunoassay cutoff) must produce negative results in each analytical run. C.3.4 A minimum of 90 percent of the open positive quality control samples (135 percent of the 500 pg/mL LSD immunoassay cutoff) must be identified as positive in each analytical run. 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 25%. C.3.6 LSD. Each immunological reagent shall be checked for cross reactivity to other illicit or pharmacological abused drugs, chemicals, or metabolites which 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.4 THE QUALITY ASSURANCE PROGRAM OF THE MANUFACTURING PROCESS MUST 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 which 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 Preventative maintenance. Routine preventative maintenance procedures, periodic calibration, and any unscheduled maintenance must be fully documented and in accordance 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 which maintain 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 sensitivity and specificity of the assay should provide sufficient cross-reactivity with the other urinary metabolites of LSD/iso-LSD ingestion such that actual human physiological urine specimens which contain 150 -- 175 pg/ml of LSD or iso-LSD(as determined by GC/MS) would show an apparent concentration of 500 pg/ml total LSD metabolic products by the reagent immunoassay procedure. While LSD is the principal compound for LSD detection, sensitivity to the presence of iso-LSD is required. Sensitivity to LSD and iso-LSD should be maximized. The reagent must provide equivalent or better performance characteristics in terms of sensitivity and specificity for detection of LSD and its metabolites in urine as the current immunoassay screening procedure used in the military laboratories. The number of "false positive" screens requiring GC/MS confirmatory analysis shall be minimized. The LSD testing reagent must be specific for LSD and its human metabolites such that no less than 90% of the actual test specimens identified as presumptive positive by the current combination of immunoassay and adjunct RIA procedures employed in the DoD military laboratories will be identified as positive by the immunoassay reagent on the Roche-Hitachi Modular system-D module at the DoD screening cutoff. The reagent shall demonstrate linearity for LSD quantitation to 200% 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 compounds and that all other parameters as specified in the contract are 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. C.5 FIRST ARTICLE TEST REQUIREMENTS. C.5.1 Reagent for testing up to 5,000 specimens within 14 days after contract award for the first article testing and approval. Testing of reagent will be performed on a pass/fa il basis. To obtain approval, the first article test shall meet the specifications, inclusive of acceptable performance lev els, set forth in C.1 through C.3 above and the manufacturers must meet requirements described in C.4 above. C.5.2 The rea gent shall be provided by the contractor in accordance with clause 52.209-4, First Article Approval-Government Testing-Alter nate I. The kits shall include a complete set of manufacturer's procedural instructions which will form the basis for perfo rmance of the test. C.5.3 The testing and evaluation of the kits will be performed by Government personnel at one of the D rug Screening Laboratories specified by the Government. C.5.4 The contractor will be authorized two observers present at t he initiation of first article testing and during the laboratory phase of testing. Following laboratory testing, the observ ers will depart the laboratory and technical evaluation personnel will analyze and summarize data. Within 14 calendar days o f completion of first article testing, the company will be notified of the results of the testing. The technical evaluation panel will be established by the Government and will be present during first article testing. C.5.5 The objective is to c omplete qualitative and quantitative testing of the offered Immunoassay reagent for LSD. The provisions at FAR 52.212-1, In structions 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. 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 on a per kit basis based on the estimated quantity of 360 kits per year. 1a(2). Offeror shall state the total number of tests per kit proposed. The number of tests shall be ba sed on the reagent volume recommended by the equipment manufacturer. 1a(3). Offeror s

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Record

Loren Data Corp. 20011226/65SOL002.HTM (A-355 SN5158S4)