Since the start of the Covid-19 outbreak, many companies and private laboratories have been promoting self-test kits that promise accurate results at fraction of the price compared to traditional tests — but the country’s medicine regulator has warned South Africans not to buy such illegal home kits.
The SA Health Products Regulatory Authority (Sahpra) has appealed to the public to report anyone selling the so-called “rapid” test kits (serological test kits) for Covid-19, saying not only are they not approved in SA and unsuitable for diagnostic purposes, but they fail to detect the disease in its early stages.
Sahpra CEO Dr Boitumelo Semete-Makokotlela said while rapid blood tests — otherwise known as point-of-care tests — are suitable for population surveys, they are not ideal during the acute phase of infection. This is in line with the recommendation of the National Institute for Communicable Diseases (NICD) and the World Health Organisation (WHO).
“They are not helpful to guide decision-making regarding patient management, decisions around the need for quarantine, isolation or contact tracing. Serological tests are used for epidemiological surveys, but not for the diagnosis of acute infections. The South African public is reminded that at this stage, the use of serological test kits is not recommended,” she said.
Currently Covid-19 diagnosis in SA is done through a laboratory test called a polymerase chain reaction (PCR) molecular test. This test investigates a sample taken from a patient’s respiratory tract, through the nose, throat or chest, which looks for the viral particles in them. Rapid tests, on the other hand, which are done through a finger prick blood test, detect whether your body has produced antibodies to the virus.
“It takes many days for the body to develop antibodies against the virus, so people can already have the SARS-CoV-2 virus and can be spreading the infection to other people but we would not be able to detect their antibodies,” said Semete-Makokotlela.
On Wednesday evening health minister Zweli Mkhize announced an increase of just 27 confirmed cases of Covid-19 in SA since Tuesday afternoon — bringing the total figure to 1,380 cases. Five people have died of Covid-19 so far.
Mkhize said to date about 44,202 tests have been conducted — about 6,000 of those in the public sector. He cautioned, however, that this was not enough given the country’s population and the rate of poverty and inequality.
As part of speeding up testing and being proactive rather than reactive, the national department of health will soon be conducting mass-testing at identified hotspots where the virus could spread rapidly or undetected.
“Rather than waiting for patients to come to hospital, we are going out to find people,” said Mkhize.
Semete-Makokotlela added that the regulator is in the process of expediting its licence process for new applications and amendments to current licences “to support the supply of medical devices that may be required in response to the Covid-19 pandemic”.