HIV testing technologies range from rapid diagnostic tests and other technologies that enable testing at the point-of-care or near point-of care, to those that are used exclusively in high-level facilities and laboratories. Although most technologies for HIV testing have high sensitivity and specificity and are highly accurate when used in a validated national algorithm, the volume of tests conducted (over 150 million tests in 2014 alone), could result in thousands of misdiagnosed cases, particularly if not conducted correctly.
Conditions in which tests are conducted are often far from ideal: reagents may be in short supply; expired tests may be used; staff may have insufficient training or supervision; suboptimal testing strategies and invalidated algorithms may be used; quality systems may be missing; and user errors may occur, particularly when reading and interpreting weak reactive lines. Other areas of potential misdiagnoses include inaccurate determinations of viral load false positive and negative serological determinations of infections related to HIV, as well as cross-reactivity due to various factors, including those at the population and individual level.
In order to gather evidence and draw attention to this topic, the World Health Organization is overseeing a special issue on the ethical, legal, human rights and public health implications of misdiagnosis of HIV status that will be published in the Journal of the International AIDS Society in 2017.