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 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 Microgenics Corporation, Freman, CA as the only source that can provide the following immunoassay reagent for lysergic acid diethylamide (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. REQUIREMENTS FOR IMMUNOASSAY TEST REAGENT FOR LYSERGIC ACID DIETHYLAMIDE. C.1.1 The materials shall be for the immunological reagent for initial (screen) testing of lysergic acid diethylamide (LSD) in urine. The reagent must provide equivalent or better performance characteristics of sensitivity and specificity for detection of LSD and its metabolites in urine as the current 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 testing 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 performed 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 characteristics in terms of sensitivity and specificity for detection of LSD and its metabolites in urine as the current LSD immunoassay screening procedure used in the military laboratories. Recognizing that physiologic urine specimens from LSD drug ingestion may contain other metabolites of LSD or iso-LSD, the sensitivity and specificity of the assay should maximize the antibody cross-reactivity for LSD and iso-LSD and their metabolites, such as 2-oxo-3-hydroxy-LSD. The assay must not cross-react with 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 spectrometry) in the presence of the various other metabolites from LSD ingestion found in urine, will 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 testing reagent must detect 90% of all quality control specimens containing pure LSD or iso-LSD at concentrations equal to or greater than 135% of the DoD cutoff concentration of 500 pg/ml. The LSD testing reagent must also maintain reproducibility in quality control (QC) and quality assurance (QA) measurements. The following drug cutoffs in urine specimens are currently 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), 2000, morphine 4000, codeine 2000; Phencyclidine (PCP),25, 25, Amphetamine/ Methamphetamine (amphetamines), 500, 500; Barbiturates (secobarbital), 200, 200; Lysergic
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