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66 -- Portland VAMC CPRR HIV HEPC Base +4 - Attachment

Notice Date
Notice Type
325413 — In-Vitro Diagnostic Substance Manufacturing
Contracting Office
Department of Veterans Affairs;Network Contracting Office 20;1495 Wilmington Drive, Suite 360;DuPont WA 98327
ZIP Code
Solicitation Number
Response Due
Archive Date
Point of Contact
Laura Davis, laura.davis5@va.gov
E-Mail Address
Small Business Set-Aside
Salient Characteristics This an Unrestricted, Brand Name or Equal notice and the brand manufacturer is Roche. The VA Medical Center seeks to acquire Cost-Per-Reportable Results - Microbiology equipment. Contractor shall provide all equipment, parts, accessories and any other item required for the proper operation of its contractor owned analyzer and peripherals necessary for the generation of a Molecular Diagnostic Testing System for viral load monitoring of quantitative HIV-1, quantitative HCV, and quantitative CMV testing services, and other tests but not limited to listed tests only for the Portland VAMC Health Care System, Portland, OR. General equipment name: 1 COBAS TaqMan 48 Analyzer and 1 COBAS AmpliPrep Instrument Description and Salient characteristics: Automated Viral load monitoring testing system, FDA approved for testing on routine blood collections FDA approved for three viral load monitoring assays (quantitiative HIV-1, quantitiative HCV, and quantitative CMV) Broad dynamic range for HIV: at most 20 cp/mL to at least 10,000,000 cp/mL Broad dynamic range for HCV: at most 15 IU/mL to at least 10000000 IU/mL Clinical and analytical data for each assay in every package insert including: At least 99.5% lot to lot specificity amongst negative specimens. Studies of precision, inclusivity, verification of limit of detection, analytical specificity, comparison of serum vs. EDTA for HCV testing, reproducibility studies of all genotypes, and predictive values studies after therapy described. Dual-probe design with built-in redundancy for genotype coverage, sensitivity to meet the requirements of current DAAs. At least 2 independently operating thermocyclers. Primers that allow for the detection and quantitation of genotypes 1, 2, 3, 4, 5 and 6 All instrumentation must fit into dedicated space in department without remodel (maximum of 106 wide x 30 in Deep) Inclusion of enzyme designed to minimize chances of contamination or carryover for each test by selective amplification: Catalyzes the destruction of DNA strands containing deoxyuridine19, but not DNA containing deoxythymidine. This way, the contaminating amplicons are susceptible to destruction by the enzyme prior to amplification of the target DNA, reducing possibility of amplicon contamination. Closed-tube processing and dedicated consumables to minimize contamination and protect the integrity of samples, UV light and independent reagent and sample pipetting. HCV testing platform must be standardized against the WHO (World Health Organization) International Standard for Hepatitis C Virus RNA for Nucleic Acid Amplification Technology Assays. Studies must have been performed to compare the WHO standard to results of the assay. Single room operation High thoughput, at least 130 samples per 8-hr shift, reagent stability once opened, ability to batch test without wasting reagent, ability to process with different reagent kits at once.
Web Link
FBO.gov Permalink
File Name: 36C26018Q9067 36C26018Q9067.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4074423&FileName=36C26018Q9067-000.docx)
Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4074423&FileName=36C26018Q9067-000.docx

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SN04816624-W 20180210/180208231201-6dd80b0f03161ecfc8a91a946f22690c (fbodaily.com)
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