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 ...
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 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 home-use 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 of this deadly infection. India's National AIDS Control Organization (NACO) told TOI that counseling patients before and after they undergo testing is vital.
"If patients find themselves HIV positive by testing at home without counseling, 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.
Union health ministry officials said at present nearly 10,000 centres across India counsel people who undertake a HIV test. In 2011, an estimated 1.6 million people got tested for HIV. Around 2.31 million people are estimated to be HIV positive in India.
"Of these, 40% don't know that they are infected. Counseling is vital. We tell those who get tested and are found HIV positive how to lead a healthy life, how we will connect them to care, support and treatment services, put them on nutritional support and prevent further spread of the virus," Dr Rewari added.
Dr Sandhya Kabra from NACO said, whenever a patient is found to be HIV positive, the test is repeated two more times to confirm the results.
"If found negative, the test isn't repeated. But if the test gives a positive result, we repeat the test for extra confirmation. Testing without counseling can make a patient take drastic measures," Dr Kabra said.
The Centers for Disease Control and Prevention estimates that there are about 50,000 new HIV infections every year. Many of these new infections are transmitted from people who are unaware of their HIV status.
Clinical studies for self-testing 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.
Clinical studies also have shown that the OraQuick In-Home HIV Test has an expected performance of 99.98% for test specificity, the percentage of results that will be negative when HIV is not present.
This means that one false positive would be expected out of every 5,000 test results in uninfected individuals.
A variety of home tests finger pricks or mouth swabs are now being developed to be used by individuals to know their HIV status by sitting at home which can produce results in one-20 minutes.
A UNAIDS report recently said the world was opening up to home testing for HIV since fewer than half of those living with HIV knew their status. This is a huge barrier to treatment scale up.
"Despite the advances in technology, testing is still approached with fear, accessing clinics is inconvenient and the experience of HIV testing is often stigmatizing. The cost of these tests is now measured in cents," UNAIDS said.
In September, 2011, the United Kingdom's House of Lords' select committee on AIDS recommended repealing laws that prohibit home HIV testing.
No comments