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Homearrow News and Events Year 2012 US OKs HIV home testing kit, upholds privacy

US OKs HIV home testing kit, upholds privacy

Times Of India.
05 July 2012

Device Gives Result In About 20 To 40 Minutes, But Doctors Warn It Is Not A Foolproof Test

New Delhi: Now, HIV can be tested in the privacy of your home. The US Food and Drug Administration (FDA) on Wednesday approved the first over–the–counter HIV test kit that allows people to test at home to see whether they are infected with the virus that causes AIDS.

The OraQuick In–Home HIV test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial and obtain test results within 20–40 minutes.

However, a positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing 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 the exposure may have been within the previous three months.

FDA says the test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods. "Knowing your status is an important factor in the effort to prevent the spread of HIV," said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. "The availability of a homeuse HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

However,India is not going to allow home testing. India’s National AIDS Control Organization (Naco) said counselling patients before and after they undergo testing is vital.

"If patients find themselves HIV positive by testing at home without counselling, it can push them to suffer from severe depression, make them commit suicide or lead to violence if women are found to be positive. Around 35% of all new cases of HIV in India are among women India. Such home testing kits can be allowed in countries with high infection rates in the general population and not in India where the epidemic is concentrated among high risk populations like sex workers," said national ART officer at Naco Dr B B Rewari.

Clinical studies for selftesting have shown that the OraQuick In–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.

FLIP SIDE: However, India is not allowing home testing for HIV. National AIDS Control Organization has said that counselling patients before and after they undergo testing is vital as a positive test can push patients to severe depression or even make them commit suicide

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