2014 saw India on the brink of a major leap forward in testing for HIV – the country was close to introducing HIV home testing. The test is a simple, peace of mind test that can tell you whether you are HIV positive or negative in matter of minutes by detecting antibodies for HIV (not the virus itself). The HIV test would be purchased in leading India pharmacies and marketed under the brand HIV TEST YOURSELF™. In the United States, The Food and Drug Administration (FDA) has already approved the home HIV Test. There are in fact 2 HIV home tests that are FDA approved in the USA:
- Home Access HIV-1 Test System: 99.9% but only tests for HIV-1 strain. The test uses a blood sample which can be collected using a sterile finger lancet.
- OraQuick In-Home HIV Test: 99.8% accurate and tests for HIV-1 and HIV-2 strain. The test uses sterile mouth swabs.
In India, home HIV test kits have yet been approved by the TgA (The Therapeutic Goods Administration which falls under the Department of Health in India) which means it is not yet available. The restrictions on selling them have been lifted by the government, however they have not yet been regulated or approved by the TGA, hence they are currently not legally allowed to be sold or exported.
The HIV test kit was much discussed at the the start of the International AIDS Conference in Melbourne which will feature some very prominent people in the field. The conference helped introduce and promote this test kit. The aim was helping driving it into the market and increasing the rate of early diagnosis.
Carrying out the HIV home test
The HIV home test is done by means of a kit. The kit is sent directly to the person requesting the test and contains the following:
- A sterile, safety, finger lancet
- A Sample Well
- A solution known as a “Developer”
HIV positive or Negative
The Sample Well is marked by a letter C and a letter T. Once the Developer solution has been added one of the following 3 results will appear:
- A pink line next to the letter C only – this means the test participant is HIV negative
- A pink line next to the letter C and another pink line next to the letter T- the means the participant is HIV positive
- *An invalid result – this is indicated by the absence of a pink line next the letter C.
Whether HIV positive or negative, a pink line must always appear next to the letter C.
Does the test provide a definite answer?
The test is not a diagnostic test and if the result shows a positive result, it is still strong recommended that the person takes a laboratory based HIV blood test to get 100% certainty that they are infected. Before somebody is given a positive result in a lab based HIV test, the sample is usually tested and re-tested. Once the person is certain to be HIV positive, they will need to carry out further tests at regular intervals to monitor the progress of the disease.
The home HIV test also has a chance of false negatives – this means that person being tested will result being HIV negative when in fact they are positive. False negatives can occur if a period of three months has not elapsed since the instant the person has contracted the virus. Chances of false positives, although small, mean that more in-depth laboratory based confirmatory testing will be required anyway if the individual’s HIV home test confirms they are HIV positive.
Do you wish to get more information about this test? Contact our office.
Articles of Interest
https://www.tga.gov.au/overview-supplying-therapeutic-goods-australia
http://www.abc.net.au/news/2017-02-07/call-to-accelerate-national-approval-of-hiv-self/8246810