A home test for HIV could go on sale within months in the US
after being given the go-ahead by regulators.
The OraQuick In-Home HIV test is expected to be available from October at
30,000 American retail outlets, its manufacturer said, with the kit allowing
people to obtain a result within 20 to 40 minutes.
It will be the first over-the-counter home testing kit for HIV - the virus
that leads to Acquired Immune Deficiency Syndrome (Aids).
The FDA noted that a positive result from the test does not mean a person is definitely infected with HIV, but rather that an additional test should be done in a medical setting to confirm the result.
"Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months," the FDA said in a statement.
The home testing kit, which detects both type 1 and type 2 HIV antibodies, could identify large numbers of previously undiagnosed infections, according to the FDA.
Similar testing indicates that one false positive would be expected out of every 5,000 test results in uninfected individuals, according to the FDA, which is responsible for regulating medication in the US.
The US Food and Drug Administration (FDA) and the company that
makes the kit, OraSure Technologies, hailed the approval as a major advance in
detecting Human Immunodeficiency Virus infections.
The test procedure involves taking an oral fluid sample collected by swabbing
the upper and lower gums inside a person's mouth, placing the sample into the
kit's developer vial and then waiting for the result.The FDA noted that a positive result from the test does not mean a person is definitely infected with HIV, but rather that an additional test should be done in a medical setting to confirm the result.
"Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months," the FDA said in a statement.
The home testing kit, which detects both type 1 and type 2 HIV antibodies, could identify large numbers of previously undiagnosed infections, according to the FDA.
Clinical studies for self-testing have shown that the OraQuick
home HIV test has an expected performance of 92% for test sensitivity, the
percentage of results that will be positive when HIV is present.
"This means that one false negative result would be expected out of every 12
test results in HIV-infected individuals," the FDA said.Similar testing indicates that one false positive would be expected out of every 5,000 test results in uninfected individuals, according to the FDA, which is responsible for regulating medication in the US.
A spokeswoman for OraSure Technologies said a price for the
over-the-counter test kit had not been decided but it would be higher than the
$17 (£11) charged for a similar product sold to hospitals, clinics and
doctors.
No comments:
Post a Comment