HIV Home Test on the Horizon

The FDA voted in favor of approving the test this week, ushering in what could become a new era of privacy and prevention

Courtesy of OraSure Technologies

This week, the FDA voted to approve an over-the-counter HIV test that could be used in the privacy of one’s home. The OraQuick In-Home HIV Test – created by OraSure Technologies in nearby Bethlehem, Pa. – provides results about whether someone is positive or negative for the virus that causes AIDS in about 20 minutes.

The test works by having the subject swab along his or her gum gum; no blood needs to be drawn and no needles are required. The test is both painless and incredibly fast. A similar version has been used by clinics around the country, including in Philadelphia, that currently offer free testing.

If the FDA approves the test kit, possibly as early as this year, the administration will likely require that any positive results be confirmed with a blood test, and followed by necessary counseling with medical professionals.

But the upside is that a test like this – one that can be used at home (without a prescription) – has the potential to let HIV-positive people know their status sooner so as to reduce the spread of the disease unknowingly.

It’s estimated that more than 50,000 people are newly infected with HIV each year in the U.S., according to the CDC. Most of these infections have occurred among gay and bisexual men, as well as African-American men and women. HIV infections are seven times higher in the black community than among caucasians, the CDC says. Pennsylvania is among the top 10 states in the country with the highest rates of infection.

The Gay Men’s Health Crisis (GMHC) in New York City has been using the OraQuick Rapid Test for the past five years. And according to a recent report, in a 22-month time period – of 6,199 tests performed – only .03 percent came back with false positives.

“No tool is right for every situation,” says Janet Weinberg, GMHC’s COO, who provided testimony in favor of approving the test to the FDA recently. “Yet the OraQuick In-Home HIV Test would be another important tool in the HIV prevention arsenal and would increase testing in hard-to-reach groups.

Adds Weinberg, “This could be a powerful tool in combating the spread of HIV.”

If you have questions about HIV prevention or risks – or would like to be tested today (it’s free and confidential) – please consider contacting any of the following organizations:

Mazzoni Center




Philadelphia FIGHT