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Alexis C. Madrigal When HIV testing first became available inthere were no anti-viral medicines to offer those who tested positive. There were no examples of long-term survivors. Testt then, just getting the test was a big deal.

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Alexis C. Madrigal When HIV testing first became available inthere 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.

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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.

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Anxiety about infection could be so nerve-wracking that some tested individuals didn't return to the clinics to learn of their. 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 Klt Technologiesthe device manufacturer. The price of the retail kit isn't set yet.

The OraQuick assay looks easy. From a technical standpoint, it resembles a home kkit 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.

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To assist consumers in interpreting and knowing what to do with at-homeOraSure has arranged for a call center with bilingual English- and Spanish-speaking support. 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. Good follow-up is critical, he said.

Participants carried out OraQuick assays using saliva and also submitted blood samples for evaluation in a laboratory.

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The saliva tests captured approximately 92 percent of positive HIV as determined by blood measurements. In other words, the sensitivity was 92 percent: on average, among HIV-infected consumers using OraQuick at home, 92 will get correct positive and 8 will get false negatives. In the same study, the oral test's specificity was over The FDA panel voted in favor. Despite limitations of the test in consumers' hands, a general sense of obligation, and respect, for their needs and preferences dominated the discussion and ultimate decision for approval.

This test offers a new option for many who wouldn't otherwise be tested. It will allow infected people to start lifesaving treatment earlier, and will help prevent transmission to others.