FDA Approves At-Home HIV Test

OraQuick Home HIV Test

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Earlier this week, the FDA approved a home testing kit for HIV. The OraQuick In-Home HIV Test, the first of its kind to gain FDA approval, relies on the user to swab his or her upper and lower gums to obtain oral fluid. OraQuick tests for antibodies to HIV and gives results in 20 to 40 minutes. The sample is tested at home; there is no need to send it to an outside laboratory.

The kit should be widely available in pharmacies and grocery stores starting this fall, although the price has not yet been established. Current prices online start at $32 per kit. Home testing has so far been approved only for people at least 17 years old, and stores may request to check an ID before purchase.

How good is the test?

In people who don’t have the virus, accuracy is extremely high; false positives can occur but are very uncommon–about 1 in every 5,000 tests. The FDA urges people who test positive to confirm the results by following up with lab testing in a health care provider’s office.

The test’s sensitivity in people who harbor the virus is 92 percent, or about 1 false negative for every 12 tests. A negative test therefore doesn’t absolutely guarantee that the person doesn’t have HIV. Many of the false negatives probably occur during the several-months-long window before an infected person develops detectable antibodies. Thus, for people who are at risk who get a negative result, repeat testing is recommended. Repeat testing is also recommended for those who continue to engage in high-risk activities.

Approximately 1 in every 5 people of the 1,200,000 believed to be infected with HIV in the US don’t know they harbor the virus. With treatment, the rate of transmission from an infected individual can be lowered by as much as 96 percent, so the wide availability of this new home testing kit has the potential to greatly limit the further spread of this disease.

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