Orasure Gets Approval for Home HIV Test

A Lehigh Valley company has won FDA approval to sell the first over-the-counter, in-home HIV testing kit for the general public.

The OraQuick In Home HIV Test, produced by ., which has headquarters at 220 E. First St. in south side Bethlehem, is expected to hit 30,000 retail and online outlets by October, according to a company news release.

The test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes, according to a U.S. Food and Drug Administration news release.

Human Immunodeficiency Virus, or HIV, causes AIDS.

This is the first rapid diagnostic test for any infectious disease that has been approved for sale over the counter by the FDA.

A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result, according to FDA.

Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months.

Clinical testing of the product showed that there could be one false negative for every 12 HIV-positive individuals and that there could be one false positive for every 5,000 HIV-negative individuals, FDA reported.

The in-home test is an over-the-counter version of OraSure’s OraQuick ADVANCE HIV 1/2 Antibody Test, which the company news release says is the market-leading rapid HIV test with millions of units sold to hospitals, clinics, community-based organizations and physician offices.

"Approval of the OraQuick In-Home HIV Test represents a major breakthrough in HIV testing," said Douglas A. Michels, president and chief executive officer of OraSure Technologies. "For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed.”

Each test kit will include detailed information on HIV and HIV testing, including step-by-step directions on how to administer the test, the news release says. Customers will also have access to a "live" toll-free customer support center and comprehensive consumer website.

The support center will be staffed with bilingual (English/Spanish) representatives who are available by telephone (toll free 866-436-6527) to answer questions about HIV/AIDS, describe how to use the test and interpret the results, and to provide direct referral to care if needed.

Support center representatives will be available 24 hours a day, seven days a week, 365 days a year and will be active starting Monday.

In addition to the support center, a comprehensive consumer website will be launched to provide access to resources and referral to follow-up counseling and medical care. The comprehensive website will launch when the product is available in October.

According to the Centers for Disease Control and Prevention, there are approximately 1.2 million people in the U.S. that have HIV and approximately 240,000 of them are unaware of their status. Those who do not know they are HIV positive are disproportionately responsible for the 50,000 new HIV infections that occur each year.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”