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FDA investigates the effectiveness of rapid tests for the diagnosis of HIV at home
Last reviewed: 23.04.2024
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The US supervisors began to evaluate the effectiveness of the use of test systems for the diagnosis of HIV infection at home. Experts of the American Food and Drug Administration (FDA) are investigating the corresponding products of OraSure Technologies.
OraQuick test strips are designed to detect carriers of the immunodeficiency virus. As a substance for the study can be used blood or plasma, as well as saliva. After 20 minutes after contacting the strip with the biological material, it will show the presence or absence of antibodies to HIV in the test sample.
According to the FDA, medical experts have been using the OraQuick test system since 2004. The reliability of diagnosing HIV infection or its absence during professional use is 99%. OraSure Technologies is going to offer its own products for mass application. In order to carry out the free implementation of test strips, the manufacturer company should obtain the consent of the supervisory service.
However, in the testing process involving volunteers, the reliability of the diagnosis of HIV with OraQuick was 93 percent. According to the requirements of the FDA, this indicator should be no less than 95%. According to the estimates of the department, in this regard, approximately 3,800 surveyed may receive erroneous information about the absence of HIV infection.
The manufacturer, in turn, declares that the free sale of rapid tests, for the purpose of implementation, which does not require the assistance of medical workers, will enable to survey a significant part of the population. For every million Americans studied, the company expects to find approximately 9,000 carriers of the immunodeficiency virus.
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