There is no legal obstacle to stop the kit from being distributed, as there is no law that requires these devices to be registered or certified. The company has been advised by MedReg Consultants that “medical devices are currently not regulated in terms of (the Medicines and Related Substances) Act 101 of 1965 and are therefore not subject to registration prior to marketing”. However, the Department of Health said that testing of all human specimens should, in terms of the Human Tissue Act, be done by an accredited medical laboratory. “This law was relaxed to accommodate the HIV crisis, by introducing rapid testing,” it said. “The conditions under which such testing is done have to be controlled. It would be difficult to protect the public from all potential hazards of home HIV testing.”
There was also criticism of home testing for HIV from the South African Medical Association (SAMA) and the Pharmaceutical Society of South Africa, who emphasised that there are medical guidelines that protect consumers. The chairperson of SAMA, Dr Kgosi Letlape, said that medical guidelines demand in particular that counselling – both before and after an HIV test – is provided as an important right of all patients in South Africa.
Homelab’s home test kit, called HIV 1/2/O Tri-line Rapid Test Device, was to be made available mainly through supermarkets and pharmacies, and promoted on the basis that it gives fast results in the privacy of your own home. Following the complaints by SAMA, however, at least one supermarket chain – Pick ‘n Pay – decided not to stock the product until it complied with appropriate guidelines. A number of pharmacies have also reportedly said they would not sell it.
The Department of Health also highlights other important ethical and legal rights of patients that might be compromised by HIV testing at home:
Informed consent: “No person may undergo any medical testing or treatment without their informed consent. This means that the person is entitled to information on the test before they give their consent to the test. Pre-test counselling must be done before HIV testing.”