Alere HIV Combo: New test holds promise for earlier detection of HIV

A test that can detect HIV infection within a week of infection, and earlier than previous generations of HIV tests has been evaluated by the federal government. The evaluation report of the test known as Alere HIV Combo Rapid Test Kit was released by the Federal Ministry of Health last Friday. The test kit is a […]

A test that can detect HIV infection within a week of infection, and earlier than previous generations of HIV tests has been evaluated by the federal government.

The evaluation report of the test known as Alere HIV Combo Rapid Test Kit was released by the Federal Ministry of Health last Friday.

The test kit is a fourth generation HIV point-of-care test that detects both free HIV 1-p24 antigen and HIV 1/2 antibodies in 20 minutes, according to its manufacturers, Abbott.

“HIV-1 p24 antigen can appear up to 7.7 days before the appearance of antibodies and can help further reduce the window period. By detecting HIV infection earlier, the Alere HIV Combo enables increased case finding at a time when individuals are up to 10 times more likely to transmit HIV than individuals with established infection,” Abbott said.

The test is not a self-test but done by any trained health worker. According to Dr Kuku Appiah, Director, Medical & Scientific Affairs – Africa for Abbott Rapid Diagnostics, Alere HIV Combo is a paper strip test, you take a finger prick of your blood, and it can be done in a clinic or at a work  place. The blood is supplied and the test and result will be given within 20 minutes.

She said: “The Alere HIV Combo is able to detect someone who is HIV positive up to a week earlier than any other test because it uses the antigen. There are chemicals called antigen and antibody in the body.

“Most of the tests out there measure the anti-body; when the virus gets into your body it produces a chemical called antibody that fights it, but the Alere HIV Combo measures the virus itself even before the body has had time to react to it. The body has a little bit of time to react once the virus enters it so the test measures the virus that is in the body. It is able detect somebody being HIV positive a week earlier than any of the other test in the market,” Dr Appiah said.

She said people who most recently acquired HIV were more likely to spread the infections. “Once someone is infected with HIV, the body is not able to deal with it in the first three weeks so the virus keeps running rampage in their system and if they have unprotected sex or if they are pregnant, they will be able to easily transmit it to the next person or child. As time goes on, over the next weeks and months, the body and the virus come to something like a mutual agreement. Then the virus itself is somehow held a bit under control so a person who has HIV for years is less likely to transmit it to the next person compared to a person who has HIV infection for days and weeks.”

Speaking during the dissemination of the evaluation report in Abuja, Minister of Health, Prof Isaac Adewole, said in Nigeria, just like in many countries of the world, detection of specific antibodies in the blood or other body fluids is the main method and standard procedure for diagnosis of HIV infection.

He said at one time in this country, several uncontrolled HIV test kits especially rapid test kits were used without any regard to quality or following any appropriate testing strategy which increased the possibility of misdiagnosis of HIV infection.

The Federal Ministry of Health considered this unacceptable and thus embarked on appropriate evaluation of HIV (rapid) test kits, he said.

He said the result of the evaluation showed that Alere HIV Combo Rapid Test Kit does not have the ability to detect p24 antigen, adding that however, the result revealed that the test kit performed better than all the test kits in the current National testing algorithm with sensitivity, specificity and accuracy of 99.7%, of 98.9% and of 99.3% respectively and is therefore recommended as a first line kit in the National HIV testing algorithm.

The report stated that the evaluation was to determine if the Alere HIV Combo (AHC), can detect early infections that are antibody negative by detecting p24 antigens.

Plasma from venous blood samples collected from the six geopolitical zones of Nigeria was analyzed at the National External Quality Assessment Laboratory (NEQAL) in Saye, Zaria by parallel testing with the screening and confirmatory test kits of the National HIV testing algorithm.  It said that specimens with concordant positive and concordant negative test results were used as standard for the evaluation.

Dr Appiah added that for the country to stop the progress of HIV, there is need to identify people who have been recently infected and put them on treatment immediately.

“So we see the Alere HIV Combo as a significant tool that any government can use to continue to identify new cases of HIV , and its quite a breakthrough. It has gone through evaluation and the Nigerian government will decide what next after that ,as well as the availability for the Nigerian market,” she said.