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FDA panel recommends in-home rapid HIV test


The U.S. Food and Drug Administration’s Blood Products Advisory Committee this week recommended approval of the first ever in-home rapid HIV test.

“We are always looking for game changers, and we believe this is one of them,” said Carl Schmid of the AIDS Institute. “Not only will it help reduce the number of infections but it will bring more people into care and treatment.”

The product – the OraQuick In-Home HIV Test – is manufactured by OraSure Technologies and is the same device as the OraQuick Rapid Test, which is already approved for use in a broad range of health care settings and is the standard of care at most testing sites around the country.

Its accuracy, ease and efficiency have been repeatedly demonstrated in national studies. The test involves swabbing saliva from the mouth and takes about 20 minutes for a reading.

“Approximately 50,000 individuals in the U.S. are newly infected with HIV each year,” said National Minority AIDS Council legislative affairs director Kali Lindsey. “Even more alarming is the fact that one in five people living with HIV in America do not know it. The OraQuick In-Home HIV Test would provide an important tool to supplement current HIV screening efforts by providing an accessible, relatively inexpensive device that can be used in the privacy of one’s own home.”

The Institute of Medicine recently examined the extent to which current policies and practices present barriers to HIV testing. It concluded that minority populations are infected at a higher rate and they shoulder a considerably higher percentage of undiagnosed HIV/AIDS cases.

“Expanded access to testing, including through accurate in-home screening, is an essential tool in slowing the spread of HIV,” Lindsey said. “At the same time, we must ensure that those who do test positive can easily access care and support services, much like those included in the OraQuick testing package.”

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