Slide 1: Why Are Most Home HIV Test Kits Not FDA Approved?
Verifying the presence of HIV antibodies is a rigorous clinical process. Although many home HIV test kits do some form of verification of the antibodies, they are way less accurate than the FDA approved tests. A false positive can cause undue mental anguish and lead to irrational decisions based upon inaccurate information. However, a false negative would be much worse. Imagine someone thinking they do not have HIV and continuing with unprotected sexual activities? In reality, home test kits that provide false negatives would be inadvertently leading to the spread of the disease! How awful is that? Have a look at HIV Test What does it take to get approved? Gaining FDA approval requires rigorous testing. Not only does the test require accuracy, it requires repeatability. This means that the test must show the presence of HIV antibodies when they do exist and not show the presence of HIV antibodies when they do not exist with an extremely high degree of accuracy. If it is not accurate, the reasons why must be known - for example - perhaps the HIV antibodies do not show up for a certain amount of time after infection and the test is taken within that time. The absence of antibodies could contribute to a false negative. When these causes are known, they become disclaimers on the testing kit so that doctors can best counsel patients on what action to take. Take a look at HIV Testing The repeatability is essential to FDA approval. This means that no matter how many times the test is taken or the type of person that takes the test, the results are still accurate. So - no matter if you're a man or a woman (or any other attribute), the test results still have the same high degree of accuracy. See to HIV Tests Other labs have verified results - is that good enough? Unfortunately, other laboratory results may not be good enough. If they were good enough, then why shouldn't the results be should be submitted to the FDA for approval? If a laboratory is unethical or run improperly, then they might consider a limited group of 80% accuracy good enough. But - for those of us who rely on the results of the test to understand what changes might occur in our lives, 80% with a small handful of hand-picked individuals isn't good enough.
