When HIV testing first became available in 1985, there were no anti-viral medicines to offer those who tested positive. There were no examples of long-term
survivors. Back then, just getting the test was a big deal. In New York state, there'd be paperwork and required counseling before and after the procedure.
Blood tubes were coded to avoid exposure of patients' names to laboratory workers. Many patients and their doctors perceived HIV as a death sentence. Those
affected feared discrimination and social isolation. Anxiety about infection could be so nerve-wracking that some tested individuals didn't return to the
clinics to learn of their results.
Times have changed: "Come October, you might check if you have the virus in the comfort and privacy of your living room," said Douglas Michels, CEO of OraSure Technologies, the device manufacturer. The product will be available on-line and in 30,000 stores including
Walgreens, CVS, Rite Aid and Wal-Mart. The price of the retail kit isn't set yet. It will be over $17.50 -- the current cost of the professional product -- but "substantially less than $60," he said in a phone interview.
The OraQuick assay
looks easy. From a technical standpoint, it resembles a home pregnancy test. Following the manufacturer's instructions, users swab the inside of the mouth with an
absorbent pad provided. Next, they insert the applicator into a liquid buffer, also provided in the package. An answer, appearing in the form of one or two reddish lines, arrives in 20 to 40 minutes. If just one line, marked "C" for control appears, the result is negative. If two lines develop, including the control, the result is positive. To assist consumers in interpreting and knowing what to do with at-home results, OraSure has
arranged for a call center with bilingual (English- and Spanish-speaking) support.
This OraQuick assay checks for exposure to HIV-1 and HIV-2. Infection with either of these retroviruses can lead to full-blown AIDS, but HIV-2 is less common in the United States. "When we do see cases
linked to HIV-2, it's usually in people from West Africa," says Gallant.
Gallant's enthusiasm for the at-home test is tempered by his concern about its limited sensitivity. Typically, HIV tests in laboratories are over 99
percent sensitive. "When people use at-home testing kits, there's a greater chance they'll wind up with a false negative test result than if they're tested
in a medical center," he said. Good follow-up is critical, he said. "A person with a positive result should always go to a medical center to have it
confirmed," he said.
When the FDA's
Blood Products Advisory Committee
met in May, it reviewed a
trial of 5,000 unskilled people at risk who'd never previously tested positive for HIV. Participants carried out OraQuick assays using saliva and
also submitted blood samples for evaluation in a laboratory. The saliva tests captured approximately 92 percent of positive HIV results as determined by
blood measurements. In other words, the sensitivity was 92 percent: on average, among 100 HIV-infected consumers using OraQuick at home, 92 will get
correct (positive) results and 8 will get false negatives. In the same study, the oral test's specificity was over 99.9 percent; false positive
results were rare.