With the FDA advisory panel recommending approval of the home rapid HIV test using saliva on a mouth swab the U.S. is making a significant change in tactics in screening for HIV. I have been in clinical practice for all but the very earliest of the history of HIV. I was a resident from 1980-1983, and in practice in the Army from 1983-1987. I remember the first patient of mine diagnosed with HIV was a woman who was just a few years post a blood transfusion for a bleeding duodenal ulcer, and who died within months of her diagnosis of multiple opportunistic infections.
In practice in WA since 1987 I’ve tried to obey the letter and spirit of the law requiring pre and post testing counseling for patients receiving HIV testing, and have grumbled that this state law pushed into place by the gay-rights lobby at a time when little effective treatment was available and serious concerns about confidentiality and discrimination were major concerns. Now that highly effective treatment for HIV is available the advantages of early HIV diagnosis would seem to make any barriers to testing for HIV counterproductive. An easy to use, affordable, reasonably accurate HIV test is a big change to the current status-quo, where considerable emphasis is placed on protection of the patient via counseling regarding results, and places more value on more widespread testing, early diagnosis and opportunities for prevention of spread of HIV.
Tests have been available for years for use by individuals to obtain their own specimen and mail it away to a test facility for confidential testing without accessing a physician or medical care provider. These have not been widely used. If the home oral swab rapid test comes to market it is very likely to be much more widely used. I fully agree with the FDA advisory panel that the benefits of this test will outweigh its risks. Still we should not ignore the risks. I see the benefits and risks as outlined below:
More HIV positive patients identified Rare false positives may lead to poor decisions
Prevention of some cases of HIV Rare false negatives may lead to not getting blood test
Low financial barrier to HIV testing Some patients may not get appropriate test results counseling
Convenience of HIV testing What unintended consequences to expect
I anticipate that in mass market use the false positive rate and the uninterpretable results rate will be higher than the extremely low rates in the test populations used in the initial studies, but even so I expect the use of a readily available home saliva HIV test will be one more step toward earlier diagnosis and slowing of the rate of spread of HIV in the U.S.