TGA may approve rapid HIV test, but only as PoCT (Point of Care Tests)

Ronen E

Problem Solver
Staff member
Moderator
#1
Following FDA approval of first home-use HIV test, the TGA is reminding that Australian legislation prevents approval for distribution in Australia of similar home-use IVDs :(. This legislation doesn't prevent ordering such products over the Internet (from overseas), for personal use.

The TGA may be happy to approve such IVD's for Point of Care use, though.

The whole story: http://www.tga.gov.au/consumers/information-devices-hiv-rapid-tests.htm

IMO, generally the positive impact of home-use HIV test on identifying unaware carriers and thus assisting hedging, outweighs the risks associated with lack of built-in pre- and post-test consultation and/or false results (the latter being validated to be rather low in the first place, in approved devices). Any approval process includes a risk management review where this balance could be evaluated on an individual device basis.
 
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B

Barbara B

#2
IMO, generally the positive impact of home-use HIV test on identifying unaware carriers and thus assisting hedging, outweighs the risks associated with lack of built-in pre- and post-test consultation and/or false results (the latter being validated to be rather low in the first place, in approved devices). Any approval process includes a risk management review where this balance could be evaluated on an individual device basis.
In the 1990's German insurance companies and politicians thought about a routine HIV-test for insurants, employees or simply all people to identify HIV infections. After some statisticians pointed out that this strategy will do more harm than good due to specificity / false positive rates even with a high specificity rate (e.g. 99.97%), this idea was buried. (Rapid tests weren't available in the 1990's, but the issues remain the same.)

What is the problem if a test has a high specificity (e.g. 99.97%) and therefore a low false-positive-rate (e.g. 100%-99.97% = 0.03%)? This looks pretty good! But if the number of infected people is taken into account the problem reveals: The number of false-positive-results among all test results could be pretty high (e.g. 5% of all positive test results could be false-positive, see attachments) even if the specificity is high or the false-positive rate is small, respectively.

If someone without profound medical knowledge gets a positive result in a rapid HIV-test, he/she will assume to be infected. Chances are high that this person is really infected, but 1 out of 20 (with example for a rapid HIV-test, see above) will get a positive results without being infected. And there is usually no one at home which could provide details on the reliability of the result and/or recommend more accurate tests (e.g. Western blot) for confirmation.

Imho it is a good decision to make those tests within a clinical setting and not at home. The consequences of a positive HIV-test are much more extensive than those of a false-positive pregnancy test (for example).

Regards,

Barbara
 

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Ronen E

Problem Solver
Staff member
Moderator
#3
Hi Barbara and thanks for sharing this.

I'm not that convinced, though. First, I believe the great majority of normative people would go see their Doctor anyway, if they got a positive response from a home-test kit (even if they don't suspect any problems with the test, they'd need treatment). I assume that any reasonable Doctor would then verify the result with a lab test. Personally, I'd be more concerned with the false-negative, as this is less likely to drive a person to go see their Doctor (or anyone), and if in fact they are infected they could unknowingly infect others. The second issue is - IMO the greatest contribution of a rapid HIV home-test is that now many more people will actually get tested. I wasn't aware of the German initiative you described, and honestly it sounds a bit extreme to me; I couldn't imagine something of that sort materializing anywhere. So, my reference point is not a mandatory lab test for the entire population, but the current state in which vast populations (maybe even some at real risk) never get tested.

There is a moral question here - which right is superior: the right of a non-carrier to avoid the stress associated with a false-positive result (until proven wrong via a lab-test), or the right of the public to avoid infection by a non-aware carrier?

Best,
Ronen.
 
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