December 14, 2005

HIV Rapid Tests Under Fire

The new oral HIV test—just a swab of your cheek, with results in 20 minutes—is in trouble. A rash of false-positives in San Francisco and elsewhere has left health officials wondering about the future of the OraQuick Advance test, which has come into wide use this year and had high hopes of going over-the-counter. “This will dampen enthusiasm for the rapid test,” predicts Jeffrey Klausner, MD, director of STD Prevention and Control Services at San Francisco’s Department of Public Health—and some of the fuss, he says, is undeserved.

The fuss started last Friday, when The San Francisco Chronicle reported that city clinics had handed out positive diagnoses to 47 people who were actually HIV negative. New York and several other cities also skewed higher than OraQuick’s touted 4-in-1000 margin of error.

A denial from the manufacturer that anything was wrong with the tests themselves was followed by calls for an investigation—but also expressions of concern that public misunderstanding of the test’s “preliminary” nature might call for an overhaul in how it is implemented.

Dr. Klausner says, in particular, that counselors need to clarify for test-takers that a positive oral test is no cause for alarm. “They should call it ‘not negative’ instead of ‘preliminary positive,’” he says, so patients will understand that blood testing is needed to determine an actual diagnosis. All HIV positive rapid-tests are supposed to be confirmed with a Western Blot blood test.

Some clinics have avoided concerns about the test by deciding not to use them at all. “My clinic didn’t switch to the oral rapid test because both counselors and patients felt more comfortable with a diagnosis coming from a blood test,” explains one HIV testing counselor in New York City, who spoke anonymously because the matter was so loaded at her workplace.

So what’s next? Even the Centers for Disease Control and Prevention (CDC) appears confused by what the news means for rapid testing—and where the government fits in. A CDC official told the San Francisco Chronicle that his agency would be adjusting its rapid test guidelines to suggest supplementing saliva tests with rapid finger-prick tests. But CDC spokesperson Jessica Frickey told POZ there would be no such change.

OraSure Technologies, manufacturer of the test, declined to respond to POZ requests for comment, but released a statement today saying, “Like all screening tests…[OraQuick Advance] is not 100% accurate and therefore a very small number of discordant or false positive results may occur.”

If the latest setbacks were to mean OraQuick’s end—or even just stop the Food and Drug Administration (FDA) from OKing an over-the-counter option—Dr. Klausner, for one, would be disappointed. “Rapid testing expanded the availability of testing,” he says. “And it requires less training for counselors than blood tests. If it were ever approved for home use, it would expand availability even more.”

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