MODIFICATION
65 -- Immunoassay Specific Screening Reagent for d-Methamphetamine
- Notice Date
- 5/21/2002
- Notice Type
- Modification
- 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-R-0010
- Response Due
- 6/12/2002
- Archive Date
- 6/27/2002
- Point of Contact
- Ralph Payne, Contracting Officer, Phone 301-619-3026, Fax 301-619-2925,
- E-Mail Address
-
repayne@us.med.navy.mil
- Description
- This was missed in the original posting. Under cutoff 125 per cent, under 200 per cent 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 REAGENT. C.3.1 The reagent shall identify specimens containing d-methamphetamine and amphetamine in human physiological urine. 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 or amphetamine used as a control material. The testing reagent must be specific for d-methamphetamine and amphetamine such that better than 95% of the actual human physiological test specimens containing d-methamphetamine or amphetamine 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 Modular Chemical Analyzer System (DDP). 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 or other over-the-counter medications. Cross reactivity with l-methamphetamine and l-amphetamine should be minimized. Better than 80% of the specimens identified as presumptive positive by the offeror?s screening reagent must confirm for the presence of d-methamphetamine or amphetamine 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, or amphetamine at the levels of quantitation of the instrumentation as defined in the military drug laboratories. The reagent shall demonstrate linearity for d-methamphetamine or amphetamine to 250% of the DoD immunoassay cutoff concentration. C.3.1.1 The contractor and the government shall cooperate to collectively work toward a decrease in the cross-reactivity to the presence of cold medications containing ephedrine, pseudoephedrine, phenylpropanolamine and also to decrease cross-reactivity to l-methamphetamine or l-amphetamine which are known to cause excessive "false positives" requiring undue burden in the GC/MS confirmation procedures. The contractor would adjust the performance of the reagent antibody and the government would provide a venue to test the performance using control and real samples. 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 100-300 samples tested between verifications of calibration. Throughout the testing of 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 and amphetamine 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 and amphetamine 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 requests negative urine, it may be shipped with the monthly reagent delivery and supplied in approximately 1 liter volume containers. The military laboratories cannot 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 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 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 amphetamine 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 or other over the counter medications 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 offeror?s screening reagent must confirm for the presence of d-methamphetamine or amphetamine equal to or above 500 ng/mL by the GC/MS procedure in the military laboratories. The immunoassay reagent must be specific for d-methamphetamine and amphetamine such that better than 95% of the actual human physiological test specimens containing d-methamphetamine and/or amphetamine and 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 Modular Chemical Analyzer System (DDP). 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.4.4.1 The contractor and the government shall cooperate to collectively work toward a decrease in the cross-reactivity to the presence of cold medications containing ephedrine, pseudoephedrine, phenylpropanolamine and also to decrease cross-reactivity to l-methamphetamine or l-amphetamine which are known to cause excessive "false positives" requiring undue burden in the GC/MS confirmation procedures. The contractor would adjust the performance of the reagent antibody and the government would provide a venue to test the performance using control and real human samples. 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 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. 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. 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 test basis. 1a(2). Offeror 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). Offeror shall provide an order and delivery schedule. 1b. Technical Proposal must be submitted in an original and one (1) copy. Offeror will provide the information specified in Technical Evaluation Factors A and B below. 2. EVALUATION FACTORS. Listed below are the technical and price evaluation factors that will be used. The overall technical factors (A-D) are substantially more important than price. 2a. Technical Evaluation Factors. 2a(1). Factor A - FDA Certification. Certification of FDA approval for the proposed d-Methamphetamine reagent. Documentation of FDA license for use shall be provided with the Offerors' proposal. 2a(2). Factor B - Quality Assurance Program. Package insert containing complete, accurate and verifiable information regarding: (1) Explanation and principles of the testing procedure. (2) Description of each reagent composition. (3) Instructions for reagent handling, mixing, and storage. (4) Reagent stability and storage requirement unopened and as an open working reagent. (5) Calibration setting for use on the Roche Chemical Analyzer Systems (DDP). (6) Calibration frequency for use on the Roche Chemical Analyzer Systems (DDP), to maintain calibration and control performance. (7) Performance characteristics anticipated in terms of accuracy, precision, and sensitivity to the principal analyte(s). (8) Table of cross reactivity and specificity to Methamphetamine and Amphetamine as compared to common over-the-counter medications, or similar isomeric analogue compounds, and other principal drugs of abuse namely LSD, l-methamphetamine, THC, barbiturates, cocaine, benzoecognine, opiates, PCP, etc. Factor C - Evaluation Test. The Government will conduct an evaluation test of offeror's reagent at the Navy Drug Screening Laboratory, Building H2033, Jacksonville, FL 23312. The test will validate that the offeror's reagent meets the statement of work. The test will be conducted in accordance with the established protocol that is posted on the NMLC home page at http://www-nmlc.med.navy.mil, click on Acquisition Management Directorate, Contractor Information, Protocol for d-Methamphetamine Testing. The offeror will ship enough reagent to test 30,000 samples, at no cost to the government, to the Jacksonville laboratory no later than the closing date of this announcement. FACTOR D - Past Performance. The contractor's past performance will be based on the Contracting Officer's knowledge of the contractor's performance on past and present like reagent contracts. Past performance is less important than evaluation factors A-C. 2b. Price Evaluation. Price proposals will be evaluated with consideration to the following: The offeror has submitted the price per test, total number of tests per kit, order and delivery schedule, completed all required representations and certifications, and acknowledgement to any amendments. Additionally, to support the offered price, offerors must include copies of published commercial price list, or other documentation setting forth the prices charged to the general public. Contract award will be based on the best value to the Government. The Offeror Representations and Certifications-Commercial Items at FAR 52.212-3 and the provision at DFARS 252.212-7000, Offerors Representations and Certifications-Commercial Items apply and must be submitted with the offeror?s business proposal. The Contract Terms and Conditions-Commercial Items at FAR 52.212-4 apply. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Order-Commercial Item (XXX2001)(Deviation) applies. With respect to FAR 52.212-5, the following clauses apply: 52.222-3, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.225-13, 52.225-16, 52.232-33, and 52.233-3. The following clauses cited in DFARS 252.212-7001 apply: 252.205-7000, 252.225-7012, 252.243-7002, 252.247-7023 and 7024. DFARS 252.204-7000, Required Central Contractor Registration applies. Addendum clauses that apply are 52.216-18, Ordering; 52.216-19, Order Limitations; 52.216-21, Requirements; and 52.209-4, First Article Approval -- Government Testing. Offeror's proposals are due at Naval Medical Logistics Command and their reagent at the Jacksonville laboratory by 1:00 PM on or before June 6, 2002. Point of contact is Ralph Payne, 301-619-3026 or email repayne@us.med.navy.mil. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (21-MAY-2002). IT ACTUALLY FIRST APPEARED ON THE FEDBIZOPPS SYSTEM ON 22-MAY-2002. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
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