A cheap Covid-19 rapid antibody test, which will cost less than R300 a unit, has been approved for use in South Africa – but it is not yet available privately or to the general public.
The South African Health Products Regulatory Authority (SAHPRA) has given the first licence to supply the rapid antibody test in South Africa to Johannesburg-based company Tip Top Trade.
Antibody testing has been described as a possible “missing weapon” in the fight against Covid-19 by several leading doctors – who also criticised the SAHPRA for being “overly cautious” in its rollout of the tests in the country.
Unlike the widely-used reverse transcriptase-polymerase chain reaction, or PCR tests, antibody tests can help people figure out if they’ve had the novel coronavirus in the past.
People who’ve been infected with Covid-19 create antibodies to fight off infections like the coronavirus, and those antibodies remain in the blood – even after the virus is gone.
Although the presence of antibodies may indicate a degree of immunity towards Covid-19, some studies suggest that people who develop coronavirus-fighting antibodies might not keep them very long, especially if they didn’t have symptoms.
There are several different antibody tests currently in circulation around the world – and local health authorities have been working to establish tests that have a suitable “sensitivity” and “specificity” in order to accurately identify antibodies and avoid producing false negatives or positives.
SAHPRA’s Dr Andrea Julsing-Keyter told Spotlight that local specifications for a rapid test were adopted from the United Kingdom’s Medicines and Healthcare Products Regulatory Authority (MHRA), and that “the specificity of 98% was met for this test.”
Tip Top Trade’s Mendy Sarchi says the test will initially be available through official public channels. It will also only become available once the ministerial advisory committee on Covid-19 releases its much anticipated national testing algorithm, setting out how serology test kits are to be used.
Once official processes have been completed, however, and the national testing algorithm changes, it is likely that the antibody tests will become available.
“We know that private labs have been in touch with SAHPRA to try and get that approval process done, but obviously SAHPRA are busy working on all the regulations. Once that’s sorted, the private sector will have guidance on how and when they can buy it,” Sarch said.
Tip Top Trade says they are confident that they have access to enough stock to supply the anticipated demand.
Tip Top Trade’s Gabi Fisher told Business Insider South Africa that the company, which focuses on medical supply and electronic product imports of various products, currently has the channels to bring in as many of the test kits as required, but “to put an available stock figure on it now won’t be possible, because these things will be changing all the time”.
According to private laboratory PathCare, they do not yet have access to an approved antibody test. Together with Lancet and Ampath, they conducted studies to compare the testing proficiency of at least four kits from different manufacturers. They have submitted their finding to SAHPRA.
In a statement, PathCare said “Many engagements have taken place over the last few weeks in order to find a way forward to allow SAHPRA to register some of these tests for use in laboratories, but to date this has unfortunately not been forthcoming. Submissions and appeals have been made to SAHPRA, the Ministerial Advisory Committee, and the National Department of Health. Unfortunately, until such time as this registration takes place, we may not offer antibody testing in our labs.”
“We obviously followed all their processes and worked closely with SAHPRA in order to get this product approved,” Sarchi says. “We knew it was a really good product and had performed well overseas, so we took the process through all the correct channels.”
In spite of criticism levelled against SAHPRA and the National Health Laboratory Service (NHLS) in expediting the rollout of antibody tests in South Africa, Tip Top Trade’s Fisher says their experience was thorough and efficient.
“Dr Andrea Julsing-Keyter, SAHPRA’s senior manager for Medical Devices and Radiation Control, has been working around the clock to ensure that all the correct processes have been followed,” says Fisher. “It’s important to emphasise that there are people working incredibly hard, in the middle of a pandemic, to get the work done.”