Loren Data's SAM Daily™

FBO DAILY ISSUE OF MAY 29, 2003 FBO #0546
SOLICITATION NOTICE

Q -- Collection of Serum Specimens Suitable for Validation of Assays with HIV-1

Notice Date

5/27/2003
 

Notice Type

Solicitation Notice
 

Contracting Office

Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
 

ZIP Code

30341-4146
 

Solicitation Number

2003-N-00872
 

Response Due

6/12/2003
 

Archive Date

6/27/2003
 

Point of Contact

William Richardson, Contract Specialist, Phone 770-488-2653, Fax 770-488-2671, - William Richardson, Contract Specialist, Phone 770-488-2653, Fax 770-488-2671,
 

E-Mail Address

rtr4@cdc.gov, rtr4@cdc.gov
 

Description

This contract shall provide for the collection and delivery of serum specimens suitable for the validation of assays for distinguishing recent from longstanding infection with human immunodeficiency virus type 1 (HIV-1). Suitable panels are to include specimens from persons with all known viral subtypes of HIV-1. The contractor(s) shall obtain and deliver specimen sets from persons who have seroconverted to HIV-1. Either of two methods may be used. For Method 1, the contractor may identify and gain access to seroconversion specimens which meet the criteria that have already been collected for other purposes (e.g., as part of longitudinal studies). For Method 2, the contractor shall develop a mechanism for identifying persons who have recently become infected with HIV-1 after previously testing negative, obtain the first HIV-1 antibody-positive specimen and prospectively collect 3 serum specimens over a period of one year from the first antibody positive specimen. C.2.2. BACKGROUND AND NEED Infection with HIV-1 is most commonly diagnosed by the detection of antibodies to components of the virus in serum or plasma. Once an individual is infected, circulating antibodies persist throughout the years-long course of HIV disease. Determining whether newly diagnosed infections are recent has important epidemiologic implications for calculating incidence of HIV infection, that is, the number of new cases per year. Incidence measurements are essential to help to identify recent patterns of transmission, and to evaluating the effectiveness of interventions designed to reduce transmission of the virus. Identifying recent infection may also have implications for clinical treatment, as some evidence suggests specific therapeutic regimens offered shortly after infection may have benefit for improving the long-term course of HIV disease. Several in vitro diagnostic strategies have been developed to distinguish incident (recent) from prevalent (longstanding) infection by detecting differences in antibody responses to HIV-1 early in the course of infection. These assays differ in their sensitivity for recent infection, and in the time identified by the assay as recent, that is, the period after infection with the virus during which the assay gives a definitive result (referred to as the window period). For some assays, the duration of this window period appears to differ with specimens from persons infected with different viral subtypes of HIV-1. For the purpose of calculating incidence, the optimal window period is 150-180 days. Evaluating candidate assays and accurately determining the length of the window period for different viral subtypes require panels of specimens from persons who have been recently infected with HIV-1 and seroconverted (that is, developed an antibody response to the virus). The necessary specimen panel requires: a)The date of the last negative HIV test; b)The date of the first positive HIV test, less than 1 year after the last negative test; c)Four or more specimens (including the first positive specimen) spaced approximately 3 months apart. It is not essential that specimens be evenly spaced, but the specimen set must span a period of at least one year after the first positive test. To date, evaluation of candidate assays have used specimens from recently infected persons (seroconverter panels) collected as part of longitudinal studies, or collected by commercial firms, often from blood or plasma donors who have become infected with HIV. Such seroconverter panels are scare, especially those with specimens spanning at least one year after seroconversion. Lack of suitable seroconverter specimen sets impedes the development and evaluation of assays for recent infection. C.2.3. CONTRACT PURPOSE The contractor(s) shall obtain and deliver specimen sets from persons who have seroconverted to HIV-1. Two methods may be used by the contractor or the contractor?s subcontractor. For the first method, the contractor may identify and gain access to seroconversion specimens which meet the criteria that have already been collected for other purposes (e.g., as part of longitudinal studies). For the second method, the contractor or the contractor?s subcontractor shall develop a mechanism for identifying persons who have recently become infected with HIV-1 (e.g., persons who become antibody positive after recently testing antibody negative, or persons who are p24 antigen positive but HIV antibody negative), obtain the first HIV-1 antibody-positive specimen and prospectively collect 3 serum specimens over a period of one year from the first antibody positive specimen. C.2.4. SCOPE OF WORK A. The contractor shall provide labor, technology, materials, supplies, equipment, travel, transportation, and other incidentals necessary to acquire the necessary panels of serum specimens and transport the specimens to the CDC storage facility in Lawrenceville, Georgia. B. The contractor must identify and acquire panels of at least four specimens from the same individual that meet the following criteria: 1) The first HIV-1 antibody positive specimen from a person known to have seroconverted to HIV-1, for whom the date of a previous negative test is available and known to be less than one year from the first positive test; or from a person with other laboratory evidence of recent seroconversion (e.g., HIV p24 antigen positive, HIV antibody negative); 2) Three subsequent specimens spaced approximately three months apart, with the last specimen collected at least one year but less than two years after the first positive specimen.
 

Place of Performance

Address: Centers for Disease Control and Prevention, Koger Center, Colgate Building, 2920 Brandywine Rd, Atlanta, GA

Zip Code: 30341

Country: US
 

Record

SN00332679-W 20030529/030527213251 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |