In the United States, the first without prescription available HIV test on the market. Users will be able to determine whether they themselves have the aids virus.
The OraQuick test works on the basis of a saliva smear. A result comes after twenty to forty minutes. The test works according to the same principle as he verklikt the presence of professional variants: for anti HIV-virus that causes aids corpuscles.
The test was just received the u.s. Food and Drug Agency permanently approved ear (FDA) and can now come onto the market within a few months, reports the BBC. According to manufacturer OraSure he would less than $ 60 (48 euros) are going to cost.
OraSure focuses on people who are not otherwise tested. Now they can do that themselves, in the privacy of their own home. The u.s. Government estimates that one fifth of the 1.2 million HIV-carriers in the us are not of themselves know that they have the virus. Tests are seen as a way to slow down the further spread of the virus.
The Wall Street Journal on Wednesday examined Bethlehem, PA.-based OraSure OraQuick Advance Rapid Technologies ' oral HIV 1/2 antibody Test and the company has to make itself the objective for at-home use (Koons, Wall Street Journal, 4/12). The oral test requires users to swab their gums and then place the swab in a holder. After 20 minutes, a line on the strip as a result of the HIV-negative, and two appear if the result is positive (Kaiser Daily HIV/AIDS Report, 3/14). Positive results of a follow-up test for confirmation (Wall Street Journal, 4/12). The FDA Blood Products Advisory Committee in a public hearing last month told OraSure needed for the drafting of a clinical study to test the accuracy and safety of the OraQuick before with the federal approval process. The Commission advised a multiple-phase of the experiment at-home HIV tests, which should examine whether people can perform the test correctly and what psychological risks exist for those who test HIV-positive. OraSure CEO Douglas Michels has said that he expects that the launch of the research this summer (Kaiser Daily HIV/AIDS Report, 3/14). He said: "The studies will be designed to the validation of the ability of an untrained user for running the test, understand the instructions for the use, interpretation of the test results and be able to correctly follow the instructions after they claimed the test" (Wall Street Journal, 4/12). Michels said that he still does not know when the tests will conclude. FDA will determine the next steps in the approval process for at-home HIV testing after the study is completed (Kaiser Daily HIV/AIDS Report, 3/14). Analysts think that the launch of the at-home test is still at least a year away, but making the test available "appears a priority at the federal level," the Journal reports. Bernard Branson, associate director of the CDC's HIV/AIDS Division of Lab Diagnostics, said: "we believe that there is a likely place for [at home] testing. We have observed during FDA hearings and other times that there is a strong Community support "to add," but we want to be sure that (the tests) are safe and effective ". OraQuick is proven reliable, despite the recent reports of false-positive results, Michels said in January. He added that the accuracy rate is in accordance with what is on the label of the product and said that the reports of the higher-than-expected false positives are limited to a few sites and probably not very many tests.