First Oral At-Home HIV Test Approved by FDA
For the first time a new test has been approved by the FDA that allows an individual to test for HIV at home without sending the test materials to a lab for results. The Food and Drug Administration approved the test for consumer purchase on Tuesday.
The test, produced by OraSure Technologies, implements a mouth swab which collects saliva. The swab is put into a test tube and the results appear about a half hour later at home. Health officials were originally worried that the test’s margin of error would create too many missed diagnoses.
Currently the test will falsely diagnose one negative result for every 12 negatives. Conversely only about 1 false positive in 5,000 occurs when taking the test. Healthcare professionals are adamant that if a user gets a negative result, it does not guarantee they are HIV-free.
Many unaware of infection
Currently about 20 percent of people in the United States with HIV are unaware they are infected. USA Today points out that about 1.2 million people currently have HIV, which means that about 240,000 people are unaware of the status of their health.
Health care officials are hopeful that the availability of a relatively sensitive and convenient at-home test will detect more cases each year, lowering the risk that the virus will spread. Previously, the test was available in a medical professional’s offices only. The margin of error of the at-home test increases without medical supervision, which concerned some of the experts involved in making the decision to release the product. Professionals urge those with a positive result to follow up at a doctor’s office right away.
The test will not be available until October and will be sold at regular drugstores, such as Walgreens and CVS. The Washington Post reports that the test will most likely sell for less than $60, according to Orasure CEO Doug Michels.
The price is meant to include the toll-free call center which can offer support and counseling for purchasers of the test. Advocates for HIV awareness hail the FDA’s decision as a major step towards detecting and treating more cases in the United States each year by offering another avenue for ascertaining individuals’ health and curbing the spread of the virus.