HHS Extends Use of Rapid HIV Test to New Sites Nationwide
February 3, 2003
HHS Secretary Tommy G. Thompson today announced that HHS has extended the availability of a recently approved rapid HIV test from the current 38,000 laboratories to more than 100,000 sites, including physician offices and HIV counseling centers.
"Ensuring the widespread availability of a rapid HIV test to outreach services in communities where people are at high risk of HIV is vital to the public health," Secretary Thompson said. "Without today's action, this test would be limited to use in laboratory settings where many high-risk people do not go for testing."
The OraQuick Rapid HIV-1 Antibody Test, manufactured by OraSure Technologies, Inc., of Bethlehem, Pa., provides results in as little as 20 minutes. It is performed on a fingerstick sample of blood. Studies show that the test has an accuracy of 99.6 percent. Unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment and can be used outside of traditional laboratory or clinical settings.
HHS' Food and Drug Administration (FDA) approved OraQuick last November for use in laboratories that perform moderate complexity testing. The expanded use to additional sites was granted by HHS under a Clinical Laboratory Improvement Amendments (CLIA) waiver.
Each year, 8,000 HIV-infected people who come to public clinics for HIV testing do not return a week later to receive their test results. With the new rapid HIV test, results are available on the spot in about 20 minutes. As with all screening tests for HIV, if the OraQuick gives a reactive test result, that result must be confirmed with an additional specific test.
Widespread availability of the rapid HIV test is likely to increase overall HIV testing and decrease the number of people -- an estimated 225,000 Americans -- who are unaware they are infected with the HIV virus. Early testing enables infected individuals to obtain medical care earlier in the course of their infection, potentially saving lives and limiting the spread of this deadly virus.
FDA approved the OraQuick test in November as a moderate complexity test. Moderate complexity tests must be performed in a CLIA-approved laboratory by CLIA-certified laboratory staff.
Manufacturers can request a CLIA waiver that allows the test to be used under less stringent controls. CLIA-waived tests can be performed and interpreted in a physician's office or other settings without having to be sent out to a CLIA-certified laboratory. To qualify for a waiver, a test must be simple, accurate and present no reasonable risk of harm.
OraSure Technologies tested the accuracy and ease of the test by having 102 untrained users administer the test at four sites in the United States, including a local AIDS foundation, a program for homeless and low income and community-based HIV organization. These users were able to obtain results similar to those obtained in the firm's original studies done in laboratories.
This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.