01-22431. Opportunity To Collaborate in the Evaluation of Rapid Diagnostic Tests for HIV

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

SUMMARY:

The Division of HIV/AIDS Prevention of the National Center for HIV, STD, and TB Prevention (NCHSTP) 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 is distributing a rapid diagnostic test for HIV and is interested in marketing the test for use in the United States. The Division of HIV/AIDS Prevention is interested in evaluating such tests. The evaluation will include determination of the sensitivity and specificity of the test, and 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 the diagnosis and/or screening for HIV in the United States.

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 October 9, 2001.

ADDRESSES:

Formal proposals should be submitted to Cassandra Walker, Division of HIV/AIDS Prevention, NCHSTP, CDC, 1600 Clifton Road, Mailstop E-46 Atlanta, GA 30333; Phone [phone]; Fax [phone]; e-mail:[e-mail] . Scientific questions should be addressed to Bernard M. Branson, MD, Division of HIV/AIDS Prevention, NCHSTP, CDC, 1600 Clifton Road, Mailstop E-46, Atlanta, GA 30333; Phone: [phone]; Fax: [phone]; e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

Technology Sought

One mission of the Division of HIV/AIDS Prevention/NCHSTP is to develop new alternatives to increase the number of persons who know their HIV infection status. The Prevention Services Research Branch is seeking rapid diagnostic tests for HIV that are suitable for commercial distribution and that are simple: preferably, tests that: use direct unprocessed specimens (e.g., whole blood or oral fluid); 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.

NCHSTP and Collaborator Responsibilities

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

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

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

(3) Publishing research results.

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

(1) Providing tests that can be used in the evaluation; and

(2) Providing NCHSTP access to necessary data in support of the research activities.

Selection Criteria

Proposals submitted for consideration should address, as best as possible and to the extent relevant to the proposal, each of the following:

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

(2) Information on the technology used for the test;

(3) Information on the time required to perform the test, whether the test is preformed on whole blood, sera, plasma or saliva, 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; and

(6) Documentation of production capacity to provide at least 500,000 tests annually, and the ability to deliver a minimum of 45,000 tests within 90 days of order.

Dated: August 29, 2001.

James D. Seligman,

Associate Director for Program Services, Centers for Disease Control and Prevention.