Food Safety Real-Time Polymerase Chain Reaction (PCR) Systems

Combined Synopsis/Solicitation 76F40126Q132810 This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) RFO Part 12, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Offers are being requested, and a separate written solicitation will not be issued. The solicitation number is 76F40126Q132810. This solicitation is issued as a Request for Quote (RFQ). For information regarding this solicitation, please contact Howard Nesmith by e-Mail at howard.nesmith@fda.hhs.gov. This acquisition is not set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov/far-overhaul. The appropriate North American Industry Classification System (NAICS) Code is 334513 - Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables; with a Small Business Size Standards in number of employees 750. This requirement is being solicited as unrestricted and made available to Full and Open competition, meaning any qualified vendor regardless of size, status may submit a quote. Statement of Need/Requirements: The U.S. Food and Drug Administration (FDA), Human Foods Program (HFP), Office of Laboratory Operations and Applied Science (OLOAS) consisting of the Office of Regulatory Testing and Surveillance (ORTS), Office of Applied Microbiology and Technology (OAMT) and Office of Chemistry and Toxicology (OCT), requires multiple Food Safety Real-Time Polymerase Chain Reaction (PCR) Systems. The Government intends to issue a single award Firm Fixed Price Indefinite Delivery/Indefinite Quantity (IDIQ) contract with a base and four (4) one-year option years as a result of this solicitation. The IDIQ minimum quantity will be 1 and the maximum quantity will be 50. The quantities below are estimated amounts based on the Government’s anticipated needs. Schedule of Items (Price quotes shall be FOB destination inclusive of inside delivery, all shipping, handling, delivery, installation, and training charges) INSTRUMENT SYSTEM CLIN 0001 - Base Year Item Description Quantity Unit Price Total Price Food Safety Real-Time Polymerase Chain Reaction (PCR) System 20 $ $ Familiarization Training‐ up to 4 users per lab 11 $ $ Shipping and Handling 20 $ $ TOTAL VALUE $ CLIN 1001 - Option Year 1 Item Description Quantity Unit Price Total Price Food Safety Real-Time Polymerase Chain Reaction (PCR) System 15 $ $ Familiarization Training‐ up to 4 users per lab 11 $ $ -- 1 of 19 -- Shipping and Handling 15 $ $ TOTAL VALUE $ CLIN 2001 - Option Year 2 Item Description Quantity Unit Price Total Price Food Safety Real-Time Polymerase Chain Reaction (PCR) System 5 $ $ Familiarization Training‐ up to 4 users per lab 5 $ $ Shipping and Handling 5 $ $ TOTAL VALUE $ CLIN 3001 - Option Year 3 Item Description Quantity Unit Price Total Price Food Safety Real-Time Polymerase Chain Reaction (PCR) System 5 $ $ Familiarization Training‐ up to 4 users per lab 5 $ $ Shipping and Handling 5 $ $ TOTAL VALUE $ CLIN 4001 - Option Year 4 Item Description Quantity Unit Price Total Price Food Safety Real-Time Polymerase Chain Reaction (PCR) System 5 $ $ Familiarization Training‐ up to 4 users per lab 5 $ $ Shipping and Handling 5 $ $ TOTAL VALUE $ GSA Contract Number: ______________________ (If Applicable) Background: The FDA/OAMT & OCT both optimize and validate rapid and highly sensitive microbiological and molecular methods and instrumentation used for recovery, detection, and quantification of enteric bacterial pathogens and their related toxins from foods and cosmetics. The ORTS laboratory network performs scientific testing on products which are regulated by FDA as well as related food processing and farm production environments. To ensure that the testing results are competent and suitable for regulatory purposes, the ORTS laboratories utilize known validated methods including Real-Time PCR protocols according to the reference methods outlined in the FDA Bacteriological Analytical Manual (BAM) for the detection of pathogens, including Salmonella, Shiga-toxin Escherichia coli, Listeria, Hepatitis A/Norovirus and Cyclospora analysis. Minimum Technical Requirements: Any catalog number, manufacturer brand name, or proprietary description used in this solicitation is used as descriptive only, not restrictive, and used to indicate type, function, or desired quality. System shall be newly manufactured, latest model, not used, refurbished, or previously used for demonstration. System Compatibility • System shall be fully compatible with current validated Applied Biosystems 7500 Fast Real- Time PCR System assays without requiring assay revalidation or modification -- 2 of 19 -- • System shall be capable of detecting a minimum of six (6) distinct targets simultaneously within a single reaction Optical System • Minimum of 6 decoupled excitation and emission filter channels (96-well format configuration) multi-channel detection • Filter combinations capability to support at least 21 distinct filter combinations to enable comprehensive multiplexing applications • Factory calibration for the following fluorescent dyes at minimum: FAM, SYBR Green, VIC, ABY, NED, TAMRA, JUN, ROX, Mustang Purple, and Cy5 Dye Compatibility • Capable of detecting target quantity differences as low as 1.5-fold in singleplex reactions sensitivity • Minimum dynamic range of 10 logs (10 orders of magnitude) dynamic range Thermal Block • System shall include a sample format of 96-well, 0.1ml reaction block configuration to accommodate standard laboratory throughput requirements • Sample format options compatible with both 96-well (0.1 mL and 0.2 mL reaction volumes) and 384-well block formats…