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Rapid HIV test--how available should it be? (On First Reading).


A new blood test for HIV-1 (the most prevalent form of the virus in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. ) and its availability to public health clinics has been under political scrutiny lately because of approval by the Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
).

The new test uses a single drop of blood, can be processed in 20 minutes and is simple to use.

The FDA, however, has approved the test for use only in labs that meet the requirements of the Clinical Laboratory Improvement Act. This means that public HIV testing sites, public clinics, and private physicians' offices, which typically do not have a laboratory on location that meets the law's regulations, are not able to perform this test. Public health officials believe that the test would be most useful in these settings.

Currently, about a third of the people tested in a public clinic or HIV test site never return for their results. But other groups feel that this test should be performed only by approved laboratories because of the potential lack of counseling, contact tracing, partner notification partner notification Public health Any formal and systematic means of informing the sexual partner(s) of a person with an STD, that the person being tested is infected with an organism–eg, HIV, N gonorrhoeae, T pallidum  and other public health measures that aren't followed if the test is given in too casual a setting.

Concern has also been expressed about the possible approval of a quick test for the home market. The FDA-approved home test is from Home Access Health Corporation and uses blood spots blood spots

spots of blood in hen eggs; an esthetic problem to the breakfast eater. They are of no disease significance and can be prevented by increasing the content of vitamin A in the diet.
 collected on filter paper.

In announcing the FDA approval, Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979
Health and Human Services, HHS
 Secretary Tommy Thompson encouraged OraSure to apply for a waiver from the regulations.

"If the FDA finds that the company's data proves that the OraQuick test is both easy and safe to use," Thompson said, "it can get a waiver. Then the test could be given in many more health care settings, perhaps even administered by social workers in HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  counseling centers. But the process can't begin until OraSure applies for the waiver, so I ask them to please apply now."

The Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center.  estimate that nearly 1 million people in the United States are infected with HIM and that approximately a quarter of them do not know it.
COPYRIGHT 2003 National Conference of State Legislatures
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Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:State Legislatures
Geographic Code:1USA
Date:Feb 1, 2003
Words:353
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