[Federal Register: February 24, 2009 (Volume 74, Number 35)]
[Notices]
[Page 8260-8261]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe09-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
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.
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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,
[[Page 8261]]
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 404-639-6379; Fax
404-639-3125; e-mail; SButera@cdc.gov.
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 404-639-6166, Fax 404-639-
0897; e-mail BBranson@cdc.gov.
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[deg]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.
[FR Doc. E9-3865 Filed 2-23-09; 8:45 am]
BILLING CODE 4163-18-M