Health ministry cautions against HIV self-test kits

By Carol Natukunda and Agencies

A wide range of HIV self-test kits are on the Ugandan market, raising panic among health officials.

New Vision has established that pharmacies are selling HIV test kits imported from China, India and several European countries. They go for as little as sh5,000.

At a pharmacy near Constitutional Square, we were able to buy a brand called Nova Rapid Test.

“You can use it for HIV and Malaria tests, but please take it to the nurse to give you directions on how to use it,” a dispenser said.

Another pharmacy on Kampala Road, a dispenser sold us the Alere Determine brand. When asked for directions for use, she retorted: “I do not know. You came to buy something you do not know how to use?”

However, Uganda’s health experts have raised concern over the issue, arguing that HIV testing should be left to the professionals and that counselling is still needed. In a phone interview on Friday, the chairman of the Uganda AIDS Commission, Prof Vinand Nantulya, described it as a disaster.

“I was not aware that they are on the open market. This has to stop immediately,” he said.

Nantulya explained that the Ministry of Health had specific guidelines regarding HIV testing.

“There are specific kits we use, which are mainly laboratory based and one has to test three times to ascertain their status,” Nantulya said.

He added that counselling should be offered as a complete package, as it can be a highly emotional issue. He stressed that in medical settings, testing is inextricably linked to counselling, to help people deal with the bad news, break it to their sexual partners and get treatment.

“Before testing, you are taken through a counselling session to prepare you psychologically. If you are negative, a professional expert tells you the methods available in order to remain negative and if you turn positive, you are advised on treatment, keeping healthy and caring for your loved ones,” Nantulya said.

Health minister Christine Ondoa said they have not approved the private sale of self-test kits and would prefer the public to continue to use the health provider counselling and testing model, recommended by the national HIV strategy.

“People need to be careful with these kits. There are several mushrooming health service providers which are illegal and not genuine. They are not approved by us,” Ondoa told IRIN/PlusNews.

“Our policy is HIV counselling and testing. As a ministry, we are improving and strengthening our health laboratory services across the country for reliable and accurate results,” she added.

The concerns come at a time when the Government is grappling with HIV high prevalence rates. Statistics show that Uganda’s HIV Prevalence has gone up from 6.4% to 7.3%, this between 2006 and 2011. Out of a population of 34million people, only 5.5 million were estimated to have tested in 2011.

While the Government is keen to have more people know their HIV status through compulsory testing, there are also concerns that the kits could be counterfeit.

“The danger of these kits is misuse. It is hard for us to test their quality,” Gordon Sematiko, the executive director of National Drug Authority told IRIN.

He added: “Those who default the law, we shall take to the professional bodies like Uganda Medical and Dental Practitioners Council, the Council of the Pharmaceutical Society of Uganda, and Allied Health Professionals Council of Uganda for disciplinary action.”



How common are self-test kits in other countries?

In the US, The Food and Drug Administration (FDA) recently approved a brand called OraQuick, a rapid HIV test kit that does not require sending a sample to a laboratory for analysis. The kit provides a test result in 20-40 minutes and you can test yourself in your own home.

The kit, which tests a sample of fluid from your mouth, is approved for sale in stores and online to anyone age 17 and older.

FDA emphasises, however, that positive test results using the kits must be confirmed by follow-up laboratory-based testing. There are concerns that the test may not always give the right result, which will either make people unnecessarily anxious or may lead them to take risks.

Clinical trials of the OraSure test showed it was accurate 92% of the time in diagnosing people who had HIV. However, this means that one in every 12 test results will be a false negative, which may encourage people to think they can indulge in unprotected sex.

False positives — where an uninfected person wrongly gets positive — were rarer, at one in every 5,000.

But some experts are enthusiastic about a home test. They argue that people who do not know they have HIV are most likely to infect others. They will be less likely to take precautions, such as using condoms.

NDA’s stand

Nasser Mbabazi, an official with Uganda National Drug Authority (NDA), says pharmacies are not allowed to sell these HIV kits to individuals. “The health ministry policy is that testing is in the hands of the health centres. So when pharmacies import them, they are supposed to sell them to health units or private medical centres that carry out counselling and testing, not to an ordinary person,” Mbabazi said.