The Bay Area Reporter - June 29, 2000
Matt Sharp, Survive AIDS Writers Pool

With new rapid tests, people can be offered treatment immediately upon finding out results, instead of leaving the test site and never returning, possibly unknowingly spreading the virus. Rapid testing would also alleviate the problem of "no shows," people who don't return to find out their results. Importantly, receiving results faster could lessen the stress and trauma brought on by waiting, get more people into the health care system sooner, and provide a better sense of how many people are infected with HIV.

Antibodies are a part of the immune response. When the body is exposed to the HIV virus it makes certain chemicals called antibodies to seek out and identify the virus or coat it for destruction. These antibodies are what the blood tests look for. Current antibody tests most commonly used, the Elisa and Western Blot, together have a greater than 99 percent accuracy rate. But, the tests take up to two weeks to get results. New rapid test technology takes less than 20 minutes and results are as accurate.

The new rapid test is used to confirm the Murex-SUDS (Single Use Diagnostic System), an older approved rapid test. The Food and Drug Administration has delayed approval on the newer rapid test because they claimed it wasn't reliable and didn't meet current standards (diagnostic tests must go through studies just as drugs do). The tests won't pick up subtypes of HIV like the Elisa and Western Blot, but do verify the prevalent HIV strain seen in the U.S.

The Centers for Disease Control and Prevention said the FDA was being overcautious in delaying approval, creating a holdup they said was wasting time and costing lives. Recently, however, the FDA agreed to accelerate the approval process, striking a bargain with the CDC. A compromise was made to allow using two rapid tests at the same time. If both test results were positive or both negative, then a confirmation would be made. However, if one test was positive and one negative, a third rapid test would be performed that would be considered sufficient enough to make a determination of sero status.

Most people would agree that the tests are important in today's epidemic. But all populations of people with AIDS are not subjected to the same health standards, therefore, the rapid tests could actually cause harm to some women.

Angela Garcia, program manager for Project WISE at Project Inform spoke out on the issue, "In the pregnancy and labor [or itrapartum] setting, rapid testing is synonymous with rapid treatment. The personal, political, and clinical implications the test may hold for women and children need to be addressed beyond short-sighted cost analysis." In other words, the rapid tests have much more serious implications for women who would essentially be forced into treatment, not necessarily knowing the risks involved. Testing would benefit the manufacturers of the test and the pharmaceutical industry, but not mothers who may be subjected to sub-optimal therapy, discrimination, and spousal abuse. Garcia says the use of the rapid tests could lead to a "slippery slope toward mandatory treatment of pregnant women."

Steve Morin, director of the AIDS Policy Research Center at the University of California, San Francisco, explained that the FDA is holding its old standards for testing and not looking at the reality of the situation. They expect older standards to be used which don't make much sense in today's epidemic. He explained that "there is no community pressure on the FDA to get these tests approved."

But at least the FDA granted a compromise so that the rapid tests can continue while more information can be gathered. Perhaps testing procedures and policies have reached an apathetic state, much like the treatment arena. If the problems of mandatory testing, names reporting, and rapid testing policy for pregnant women can be sorted out, then there may be reason to believe that many more people will get into treatment, if they so chose, and more lives can be saved.

000629
BR000606

Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2000. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .