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? 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 k
