Sampler, Biological Agent

MEDICAL PROCUREMENT ITEM DESCRIPTION SAMPLER, BIOLOGICAL AGENT 1. Scope. This Medical Procurement Item Description covers the requirements of a Pathogen Identification Device. The product shall be an Idaho Technology Inc. R.A.P.I.D. (Ruggedized Advanced Pathogen Identification Device) system or equivalent having the following salient characteristics. The R.A.P.I.D. is a field-hardened rapid thermocycler with concurrent fluorescence monitoring. The R.A.P.I.D. is capable of automatically analyzing samples for the presence of any DNA sequence. 2. SALIENT CHARACTERISTICS: 2.1 INSTRUMENT. 2.1.1 Shall be a portable temperature controlled micro-volume fluorimeter. 2.1.2 Shall have the capacity for 32 samples. 2.1.3 Shall have a real-time display of fluorescence and temperature data in Windows based software. The data shall be stored as a text file (.txt). 2.1.4 The weight of the system shall be approximately 50 lbs which includes the backpack, laptop computer, micro-centrifuge, and sample cuvettes. The dimensions of the system shall be approximately 20 inches x 15 inches x 11 inches. 2.2 SAMPLE. 2.2.1 Shall have composite glass/plastic reaction vessel loaded by centrifugation with a volume size of 5-20 - l. 2.3 FLUORESCENCE ACQUISITION. 2.3.1 The system shall have three color optics modules with excitation wavelengths of 450 - 490 nm. The color emission wavelength detection channels shall be: Channel 1: 520-540 nm Channel 2: 630-650 nm Channel 3: 690-730 nm 2.3.2 Shall have a dwell time of 60-1000 millisec/sample. The sample rate shall have a maximum of 6 seconds for 32 samples. 2.3.3 The instrument shall have the following 3 modes: 1. Continuous 2. Once per Cycle 3. Single Step. 2.4 PROGRAMMING. 2.4.1 Shall have Windows based software with 2 operating modes: 1. Simplified: Push button operation with automatic results analysis for field use. 2. Advanced: Programming and data analysis for protocol testing and development. 2.4.2 The auto-run protocols shall be capable of storing 24 push-button protocols with automatic analysis. 2.4.3 The advanced protocols shall be capable of storing hundreds of protocol programs, with up to 100 cycle programs per protocol. Each Cycle program can contain up to 100 Target Temperatures. Target Temperatures consist of: temperature, time, slope, step functions, and acquisition mode. 2.5 TEMPERATURE CONTROL. 2.5.1 The temperature range shall be from room temperature to 120'C. The ramp rate shall be 0.1 - 2.0'C/sec. 2.5.2 The electrical requirements shall be 220-240 volts 50/60 Hz. 2.6 This system shall include a Laptop computer, Start-up Kit, Bubble Centrifuge and Adapters, Black Backpack, Basic Use Tools Kit, Composite Reaction Cuvettes, Cords, Cables and a Users Guide. 2.7 The Pathogen Identification Device shall be provided with the following consumables/kits or equivalent. - 1. IT Training Kit - The kit contains 6 pouches. Each pouch contains 1 positive, 1 negative, and 3 unknown vials and 1 water vial for each sample target. (1 vial is equal to 2 reactions) - 2. IT Biothreat Kit - Agents: B. Anthracis, Y. Pestis, F. Tularemia, Brucella (all Target 1). Each kit contains 2 pounches. Each pouch contains: 1 positive, 1 negative, and 2 unknown vials for each threat target. (1 vial is equal to 2 reactions) - 3. IT 1,2,3 Swipe Sample Purification Kit - 40 DNA Extractions. Each kit contains: Buffer 1, Buffer 2, Buffer 3, small bead tubes with beads for lysis, small spin filters, small receiver tubes, small transfer pipets, IT swabs for surface, powder and culture sampling, swab snippers, wipes and SWIPE instruction booklet. - 4. Ready Response Kit - This kit compliments the Pathogen Identification Device with all of the additional accessories necessary to perform successful tests on the go. The kit contains: Super Trekker AW Backpack, Reaction Cuvettes (96/box), P-100 Pipettor, P-1000 Pipettor, Pipettor Gloves-Sm, Med, Lg, 100 - l Medium Barrier Tips, 1000 - l Large Barrier Tips, Vortex Genie w/TurboMix Adapter, VWR Galaxy 7D Micro Centrifuge, Microcentrifuge Tube Racks, Tweezers, Bleach/Wipes, DNAZapTM, Kit Absorbent Papers, Biohazard Bags, Six Outlet Power Strip, 20 Ft. Power Extension Cord, and Manuals / Software CD. 2.6 Workmanship. The Pathogen Identification Device shall be free from defect that detract from its appearance or impair its serviceability. The products provided shall meet the salient characteristics of this Medical Procurement Item Description and conform to the producer's own drawings, specifications, standards, and quality assurance practices. The government reserves the right to require proof of such conformance. 3. REGULATORY REQUIREMENTS. 3.1 Federal Food, Drug, and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations. 3.2 Recovered Materials. The offeror/contractor is encouraged to use recovered materials in accordance with the Federal Acquisition Regulation (FAR) Subpart 23.403 to the maximum extent practical. 4. QUALITY ASSURANCE PROVISIONS. - 4.1 Contractor Certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Procurement Item Description, and that the product conforms to the producers' own drawings, specifications, standards, and quality assurance practices, and is the same product offered for sale in the commercial market-place. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract. 4.2 Metric Products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units. Dimensions and tolerances specified shall be converted using conversion tables contained in the latest revision of ASTM E 380. 4.3 Other quality assurance provisions. Shall be as indicated in Section E, Inspection, of the contract and/or order. 5. PACKAGING. 5.1 Preservation. Preservation shall be commercial, as specified in the contract or purchase order. 5.1.1 Unit. Each (EA). One Thermal Transport Container, as specified, constitutes one unit. Overpacking shall not be required. 5.2 Packing. Packing shall be commercial, as specified in the contract or purchase order. 5.2.1 Commercial. Exterior (shipping) container shall contain one unit. 5.2.2 Unitization. Material shall be unitized on 4-way entry pallets as specified in the contract or purchase order. 5.3 Marking. 5.3.1 Unit. Each unit shall be marked in accordance with commercial practice. Marking shall include the National Stock Number (NSN), quantity and unit of issue, the manufacturer's name and address, and the legends "ARMED SERVICES BLOOD PROGRAM" and "PERISHABLE & FRAGILE" in permanent black ink, and the legend "HUMAN BLOOD" in permanent red ink. Directional "UP" arrows shall be permanently printed in black ink in the upper corners of all sides of the box.. 5.3.2 Unitized load. Each unitized load shall be marked as specified in Medical Marking Standard No. 1. 6. NOTES. 6.1 National Stock Number Data. The following National Stock Number and its respective item identification is covered by this document: NATIONAL STOCK NUMBER ITEM IDENTIFICATION 6665-01-500-5694 with consumables/kits SAMPLER, BIOLOGICAL AGENT PROJECT NUMBER: LOCATION: