Sexual Health news - HIV

FDA committee approves use of at-home HIV tests in spite of criticism


On May 15, the U.S. Food and Drug Administration's (FDA's) Blood Products Advisory Committee voted to approve a brand of at-home HIV test for commercial use. The product will need to undergo a final review by the FDA before being approved and marketed to the general public.

The kit, called OraQuick In-Home HIV Test, was the subject of debate over the rate of false negatives it is projected to give.

Before Tuesday's hearing, the panel discussed the possibility that the test could provide several thousand false negative results to users, which may stem from improper use of the equipment or the fact that HIV antibodies in newly infected individuals may be too low for the test to detect.

OraQuick consists of a swab, which users swipe across their gums, and provides results on a stick, much like a home pregnancy test.

A report in the Philadelphia Inquirer stated that proponents of the test emphasized that it could potentially diagnose 2.8 million people during its first year on the market – 45,000 of which may not have otherwise been detected, as per estimates from the FDA. Additionally, it was noted that detection not only results in better treatment for the patient, but also prevents the spread of the virus.

"We believe we are at a deciding moment in the trajectory of the AIDS epidemic," said Phill Wilson, executive director of the Black AIDS Institute, quoted by the news source, referring to treatments that dramatically reduce transmission of HIV, the virus that causes AIDS. "The key to that begins with getting them tested."

A report in MedPage Today stated that OraQuick may result in one false negative for every 13 actual negative results given. In total, that adds up to about 3,800 people per year who may go on to practice risky sexual behavior.

"There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status," FDA staff wrote, according to MedPage Today. "However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected."

Estimates of potential rates of diagnoses were based on human clinical trials of OraQuick involving 5,558 people. Of the study participants, 106 received positive results, while eight were initially given false negatives.