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Rapid Tests Will Save Lives

September 2002

As the cover story in this month's Treatment Issues shows, the haves and have-nots in this epidemic need not be separated by oceans and continents. The crisis in funding for the AIDS Drug Assistance programs may soon deprive thousands of U.S. residents of the drugs they need to save their lives. Of course, this disaster need not happen if Congress appropriates $162 million for the ADAP program for the next fiscal year. Will our members of Congress abandon the neediest people with AIDS in their own states? The answer is uncertain and the equivocation of politicians on this issue is indeed sickening, both literally and figuratively.

Another drama that upsets our notion of have and have-nots in the epidemic is quietly unfolding in Atlanta and Washington, D.C. Over the past few years, rapid and simple tests to diagnose HIV infection have been developed and widely deployed in Africa, Asia and Europe. These rapid HIV tests can offer an HIV diagnosis in less than half an hour and can be performed by anyone with a bit of training -- no laboratory is necessary to use these truly revolutionary new technologies. With up to 40 percent of people who take the conventional test never returning for results and with a critical need to bring mobile testing and counseling to overlooked populations, rapid tests are the key to a new era of HIV prevention.

However, rapid HIV tests have not been available in the U.S. because, until recently, no company had asked to market one here. One reason is that the big diagnostic test manufacturers who sell rapid tests elsewhere in the world are worried about upsetting the market for their slower, lab-based assays. But this year, a small company, Orasure Technologies, applied to sell a rapid HIV test in the U.S. Orasure's application is now before the FDA, which is reviewing the data and is expected to make a decision soon.

Here is where things get complicated. Unlike AIDS drugs, several different agencies have jurisdiction over the fate of rapid tests. The FDA will review safety and efficacy data, just as it does for pharmaceuticals. But with rapid tests, the Center for Medicaid and Medicare Services (CMMS) gets to weigh in on how these tests will be used. What is at stake here is whether Orasure's test will be classified by CMMS as "moderately complex" or be a "waived" test. A "moderately complex" label will drastically compromise the revolutionary promise of rapid testing by mandating that only qualified laboratories or laboratory personnel can offer these assays. If community-based organizations want to use these tests in-house or as part of enhanced prevention outreach strategies, they would have to bring laboratory personnel on board, as well as comply with a set of onerous rules and regulations that come with the "moderately complex" designation. If Orasure's test receives a waiver, it can be more broadly and less restrictively used.

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The opposition to giving Orasure a waiver is largely coming from, you guessed it, laboratory personnel, laboratories and their fellow travelers within CMMS, which see rapid testing as a threat to their hegemony over HIV diagnoses and the funding that comes with it. Rapid testing cuts out the need to send your HIV test to a lab for analysis and the laboratory middlemen are hopping mad. The lab lobby is claiming that rapid tests are far too complex to perform without expensive laboratory support -- even though they are being used successfully in remote villages in Africa right now. They claim that there will be insufficient oversight, training and quality assurance for these tests -- although HIV testing in the U.S. is already highly regulated and there is broad agreement that training and quality assurance programs need to go hand-in-hand with the implementation of these technologies in the field.

Every year in the U.S., 700,000 people do not come back for their HIV test results. How many of these eventually walk into an emergency room with PCP but could have been saved if we could offer test results in 20 minutes instead of a week's time?

There is nothing standing in the way of rapid testing in the U.S. but greed and bureaucratic intransigence. CMMS should "waive" Orasure's test when it receives FDA approval and stop this nonsense. They were told as much this month by a panel of experts at a consultation sponsored by the CDC in Atlanta, which brought together all the parties interested in the fate of rapid testing. The deployment of rapid testing in the U.S. has been delayed and delayed again. It's time to get moving.



  
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This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.
 
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