FDA approves rapid HIV test

Posted 9:12 p.m. Feb. 4

by Carolyn Polinsky
U-WIRE Washington Bureau

President George W. Bush announced Friday that the Food and Drug Administration has approved the use of a rapid HIV test outside of clinical laboratories, making it possible for the 20-minute test to potentially be allowed in doctor’s offices, clinics and community-based organizations.

The OraQuick Rapid HIV-1 Antibody Test, which examines a sample of blood from a pricked finger, will be allowed at more than 100,000 sites instead of the 38,000 laboratories where it is now used.

“Ensuring the widespread availability of a rapid HIV test to outreach services in communities where people are high risk of HIV is vital to the public health,” said Health and Human Services Secretary Tommy Thompson. “Without today’s action, this test would be limited to use in laboratory settings where many high-risk people do not go for testing.”

Each year, an estimated 8,000 HIV-infected people who go to clinics to test for the disease do not return for the results. With OraQuick, administrators will be able to give on the spot readings of results.

OraQuick was approved in November for use in laboratories and was rated as being a test of moderate complexity. The FDA encouraged the product’s manufacturer, OraSure Technologies, Inc., to apply for a waiver to allow further usage.

Some medical technologists fear that while the approval may lead to more testing, the staff at new sites won’t be qualified to give tests.

They also worry that people who think they have recently been exposed to the virus will take the 20-minute test and be satisfied with a negative result ant not partake in further testing. Because antibodies that show the presence of HIV take three to six months to develop, patients who want to know if they have the virus are required to take multiple tests. The one to two week waiting period required by most tests make it more certain that a patient will have to stay in contact with his testing place.

In clinical studies performed by OraSure in laboratories, OraQuick was found to have a 99.6 percent sensitivity, the measure of how often those known to be positive or at high-risk for a disease are identified as being so according to tests. Its specificity, which measures tests people known or presumed negative, is 100 percent.

According to the Department of Health and Human Services, OraSure studied the accuracy and ease of the test in nonlaboratory settings by having 102 untrained users perform the test at for sites in the United States, such as a local AIDS foundation, a program for the homeless and low income and community-based HIV organization. Results were similar to the original study, according to the department.

Almost one million Americans have HIV/AIDS and as many as one in three Americans don’t realize they have it, according to information from the Kaiser Family Foundation. It is the leading cause of death worldwide.

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