Soon enough American consumers will be able to purchase an HIV self-test kit that could effectively and quickly tell if they were infected with the AIDS-causing virus.
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The U.S. Food and Drug Administration approved this week the prescription-free retail of OraQuick In-Home HIV test kit, which its manufacturer, OraSure Technologies, will introduce to the U.S. market October this year.
OraSure chief executive Douglas Michels said in statement that the new product will find its way to more than 30,000 stores across the United States and where customers can buy it over-the-counter for approximately $US60 per test kit.
Mr Michels told Agence France Presse (AFP) on Tuesday that once OraQuick becomes commercially available, Americans would "learn their HIV status in the comfort of their home and obtain referral to care if needed."
He added that OraSure is mapping a massive marketing effort to advertise the innovative product, which replaces the earlier testing kit that the company offered for only $US17.
"We expect all the major retail outlets to carry this product," Mr Michels was reported by BBC as saying.
According to the FDA, OraQuick will be able to detect type 1 and type 2 Human Immunodeficiency Virus (HIV) antibodies with 92 percent accuracy, the same level that determines if a person is HIV-positive.
The whole procedure would only require a person to take saliva samples by swabbing both gums and then resting the specimen to a vial provided with the kit.
A wait of 20 to 40 minutes is required before a result will be delivered by the kit, the FDA said.
But the U.S. health regulator clarified that the test kit should be regarded only as reliable precursor of actual medical tests, which ultimately should confirm the positive or negative HIV indicator yielded through OraQuick.
"One false negative result would be expected out of every 12 test results in HIV-infected individuals," the FDA said in a statement.
Simply put, results from the testing kit cannot be taken as the absolute diagnosis of HIV infection "particularly when exposure may have been within the previous three months," the U.S. agency stressed.
But what is remarkable with the new product is the idea that people now have the option to get an HIV test privately, which should prompt them to seek medical help afterwards and in the process contribute greatly in preventing the spread of the virus, according to FDA's Centre for Biologics Evaluation and Research director Karen Midthun.
OraQuick is expected to benefit the 1.2 million Americans that the Centres for Disease Control and Prevention (CDC) said could be infected by HIV, with about 20 percent of them seemingly clueless of the alarming condition.
While the product is 99 percent accurate in determining if a person is free from HIV, as per OraSure claims, Dr Jonathan Mermin of CDC told BBC that a test should be done again after three months as it normally takes some weeks before the antibodies for the virus were actually detected by any kind of tests.
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