Friday, May 11, 2012

FDA Sets Eyes on OraQuick's In-Home HIV Test

On May 15, 2012, the U.S. Food & Drug Administration (FDA) will discuss the safety and effectiveness of the OraQuick In-Home HIV Test. This is a test which consumers would be able to purchase over the counter, take home and in 20 minutes find out their HIV status. Who’s Positive conducted a Nationwide Survey and gathered responses from 1,569 participants.

Overall, the survey findings demonstrate support for rapid OTC testing - particularly from the HIV community - with approximately half of the respondents identified as people living with HIV/AIDS.  It should be noted that the survey was conducted online, and thus its findings are not scientific.  However, it offers some interesting insights.

Seventy-four percent (74%) of respondents said that they would support an OTC rapid, oral swab HIV test that could be purchased in a retail store, if approved by the FDA.

Other key findings of the survey found:

  • 66% of the respondents who identify as a HIV-positive consumer support an OTC HIV test;

  • 80% of those aged to 30 support an OTC HIV test;

  • A majority or nearly 52% of those who identified as a paid member of an HIV/AIDS organization support an OTC HIV test; and

  • 47% of those who identify as one who performs HIV testing support an HIV OTC test.

  • “Our survey demonstrates widespread support for additional testing options, especially among younger generations and those who are already living with HIV,” said Tom Donohue, Founding Director of Who’s Positive. "Over-the-counter testing has the potential to break down barriers and empower people who have never been tested before to learn their HIV status and, if positive, find the care and support they need."

    How will an over the counter test affect already cash strapped AIDS Drug Assistance Programs? The jury is still out on that. As of May 10, 2012, there are 2,759 individuals on ADAP waiting lists in ten (10) states, according to the National Alliance of State & Territorial AIDS Directors (NASTAD) report. The number of states with waiting lists and individuals on them held relatively steady from last week’s update with a total increase of 55 individuals.

    1 comment:

    Anonymous said...

    Of potential concern: the Phase III study of the OTC test indicated that the sensitivity of the assay -- essentially its ability to rule out false-negative results (when someone tests negative for the virus when they're really positive) -- is 93 percent. Essentially, a large swath of people using the test will ultimately assume they're negative when they're really not.

    Consider this from the FDA briefing document:

    This model predicts that, given the estimated sensitivity of the OraQuick® In-Home HIV Test in the Phase III clinical trials, we would expect one false negative test result for every 13 true positive test results, or approximately 3,800 false negative test results per year. If we assume that the true sensitivity of the OraQuick® In-Home HIV Test is equal to the lower bound of the 95% CI, then we would expect one false negative result for every six true positive test results, or approximately 7,000 false negative test results per year. Finally, we compare this projected false negative rate for the OraQuick® In-Home HIV Test to that which would be expected from a test with 95% sensitivity (corresponding to the BPAC-recommended minimum acceptable performance). We see from this analysis that we would expect one false negative result for every 19 true positive results, or approximately 2,500 false negative test results per year.