SOLICITATION NOTICE
R -- Pertusssis Serology Bridging Study
- Notice Date
- 5/18/2012
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2012-45486
- Archive Date
- 6/1/2012
- Point of Contact
- Phil D Alexander, Phone: 770-488-2067
- E-Mail Address
-
pfa5@cdc.gov
(pfa5@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention (CDC) National Center for Enteric Diseases Laboratory Branch intends to award, on a sole source basis, a contract to Vanderbilt University Medical Center, 1161 Avenue South, Nashville, TN. The collaborators/contractors, Vanderbilt University Medical Center (VUMC) will conduct a bridging study with the Centers for Disease Control and Prevention (CDC) to determine the correlation of a newly developed pertussis Luminex IgG assay with a standardized multi-dilution IgG ELISA. VUMC will evaluate comparability of their ELISA to two different antigen sources (VUMC in-house antigen and NIH antigens) for the four pertussis antigens: pertussis toxin (PT), pertactin (PRN), filamentous hemagglutinin (FHA), fimbrae 2/3 (FIM 2/3). Once comparability has been established, VUMC will use a standardized multi-dilution IgG ELISA (gold standard) to test 400 anonymized NHANES III samples, in 3 independent runs, to the four pertussis NIH antigens. Samples will be shipped directly from the NHANES serum repository. For those antigens in which comparability could not be established, VUMC will use their in-house antigens for testing of NHANES III specimens. Testing via Luminex will be conducted at CDC also on 3 independent runs. Antibody levels (EU/ml) from each run for the four antigens will be submitted to CDC for statistical analysis to evaluate equivalence of the Luminex assay to the gold standard ELISA for each antigen. For the secondary objective, the multi-dilution ELISA will be compared to NHANES III historical results to evaluate bioequivalence of serologic responses to three pertussis antigens (PT, FHA, and FIM 2/3). Subject acqusition is subject to FAR Part 13. The performance period of subject order will be 1 year from date of order. The government intends to award a Firm-Fixed Price contract. The place of performance is the contractors facilities. Market research indicates that Vanderbilt University is the only institution that can provide the Bridging Study. This is not a request for competitive proposals and no solicitation is available. All responsible sources that believe they can provide the services are encouraged to identify themselves and submit a capability statement to the Contracting Officer within 10 days of the publication date of this notice. A determination by the Government not to compete this proposed action based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining to conduct a competitive procurement. All vendors/prospective contractors must be registered with the Central Contractors Registration (www.ccr.gov) prior to award date. If not registered or active by that date, vendor proposals will be considered non-responsive. Inquires may be sent to Phil Alexander by e-mail at PFA5@CDC.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2012-45486/listing.html)
- Place of Performance
- Address: 1161 Avenue South, Nashville, Tennessee, 37232, United States
- Zip Code: 37232
- Zip Code: 37232
- Record
- SN02752414-W 20120520/120519000353-75f12df58af8e83ae8c6a0904b85a3fa (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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