E9-3865. Opportunity To Collaborate in the Evaluation of Rapid Diagnostic Tests for HIV and HCV

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS).

ACTION:

Opportunities for collaboration for evaluation of rapid diagnostic tests for HIV and hepatitis C virus (HCV). The Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), has an opportunity for collaboration to evaluate diagnostic tests for HIV and HCV. These evaluations will include evaluation of the sensitivity and specificity of the tests, and the predictive value of algorithms using two or more different rapid tests in combination.

Specific tests are sought to meet one or more of the following purposes: (1) Laboratory-based or rapid point-of-care tests designed to detect both HIV antigen and antibody; (2) laboratory-based or rapid point-of-care tests that can distinguish persons with acute HIV infection from persons who have longer-standing HIV infection; (3) laboratory-based or rapid point-of-care tests that can be used as supplemental confirmatory tests to help diagnose HIV-1 or HIV-2 infection, (4) rapid laboratory-based or rapid point-of-care tests designed to detect HCV antibody, antigen or both. Tests of interest include those that can detect HIV-1/2 and/or HCV antibody, antigen, RNA, or DNA when used on whole blood, serum, plasma, oral fluid or dried blood spots. Evaluations will include the sensitivity and specificity of the test when used in the intended application (e.g., for screening or confirmation).

SUMMARY:

The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) at the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (DHHS) seeks one or more companies that have developed or are distributing rapid diagnostic tests for HIV or HCV and are interested in marketing the tests for use in the United States. The Division of HIV/AIDS Prevention and the Division of Viral Hepatitis are interested in evaluating such tests. The evaluation will include determination of sensitivity and specificity of the test, and may also evaluate the predictive value of two or more different tests used in combination in populations of low prevalence. This collaboration will have an expected duration of two (2) to three (3) years. The goals of the collaboration include the timely development of data to be used to determine whether the test could be used in screening and/or diagnosis for HIV or HCV in the United States, and to examine laboratory-based or rapid point-of-care tests. These tests require high sensitivity to detect persons with acute and longer-standing HIV infection; or high specificity to distinguish persons with acute infection from those with longer-standing infection; or high specificity for tests that can be used as to confirm HIV-1 or HIV-2 infection. Acute HIV infection is defined as the early infection period associated with a transient symptomatic illness, high viral load, and expansive immunologic response. For HCV testing, rapid tests to be used in the screening setting require high sensitivity and confirmatory tests with high specificity.

Confidential proposals, preferably six pages or less (excluding appendices), are solicited from companies who have a product that is suitable for commercial distribution.

DATES:

Formal proposals must be submitted no later than 30 calendar days after date of publication in the Federal Register.

ADDRESSES:

Formal proposals should be submitted to Sal Butera, Associate Director for Laboratory Science, NCHHSTP, CDC, 1600 Clifton Road, NE., Mailstop E-07, Atlanta, GA 30333; Phone [phone]; Fax [phone]; e-mail; [e-mail].

Scientific questions should be addressed to Bernard M. Branson, M.D., Division of HIV/AIDS Prevention, NCHSTP, CDC 1600 Clifton Road, NE., Mailstop D-21, Atlanta, GA 30333; Phone [phone], Fax [phone]; e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

Technology Sought

One goal of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) is to develop new approaches to increase the number of persons infected with HIV and/or HCV who know their status and have access to effective treatment. These approaches might include increasing the use of more sensitive screening assays (such as antigen or nucleic acid amplification tests) that can identify persons with acute HIV infection; rapid tests that can identify resolved or ongoing HCV infection; and more sensitive and specific confirmatory assays that can be used at point-of-care to obviate the need for clients to return for confirmed test results. NCHHSTP is seeking rapid diagnostic tests that are suitable for commercial distribution and that are simple: preferably, tests that use direct, unprocessed specimens (e.g., whole blood); can be performed in 30 minutes or less by persons with minimal training; include all necessary reagents in the test kit; can be stored at temperatures between 25 and 39°C; and have a minimum 1-year shelf life. Of particular interest are tests with high sensitivity for early stage HIV infection and tests that can distinguish persons with acute or recent HIV infection from persons with longer standing infections. NCHHSTP also seeks new methods that could serve to expedite confirmatory testing for HIV-1, HIV-2, and HCV either at the point-of-care or in the laboratory.

NCHHSTP and Collaborator Responsibilities

The NCHHSTP role may include, but will not be limited to, the following:

(1) Providing scientific and technical expertise needed for the evaluation project;

(2) Planning and conducting evaluation studies of the diagnostic tests and interpreting results; and

(3) Publishing evaluation results.

The NCHHSTP anticipates that the role of the successful collaborator(s) will include the following:

(1) Providing NCHHSTP access to data necessary to identify candidate tests for further evaluation; and

(2) Providing tests that can be used in the evaluation.

Selection Criteria

Proposals submitted for consideration will be evaluated according to selection criteria, and should address, as best as possible and to the extent relevant to the proposal, each of the following:

(1) Information on the technology used for the test, including basic operating principals such as antigen or antibody components used for detection;

(2) Data available on the performance characteristics of the tests in different populations;

(3) Information on the time required to perform the test, whether the test is performed on oral fluid, whole blood, serum, plasma, or dried blood spots, and the steps involved in performing the test;

(4) Information on the storage requirements and stability of the test;

(5) Interest by the company to seek FDA approval and market the test in the United States;

(6) Ability to provide to CDC approximately 8,000 tests and all related equipment to enable laboratory validation at CDC;

(7) Documentation of production capacity to provide at least 500,000 tests annually.

Dated: February 13, 2009.

James D. Seligman,

Chief Information Officer, Centers for Disease Control and Prevention.