First antibody test gets limited go ahead from SA regulator

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The first COVID-19 antibody rapid blood test kit has been approved for use in South Africa, but, Spotlight reports, it is strictly not for sale to the public or for use by general practitioners.

The South African Health Products Regulatory Authority (SAHPRA) has given the nod for the supply of a single finger prick (point of care) serology test. In addition, approval of the first laboratory-based COVID-19 antibody test in the country is also imminent.

Dr Andrea Julsing-Keyter, SAHPRA’s senior manager for medical devices and radiation control, told Spotlight that a licence to supply the rapid test kit called Orient Gene COVID-19, had been given to Tip Top Trade (Pty) Ltd and that more applications for licences to supply the kit have been made.

The Chinese product has been authorised for use in China and has been approved by authorities there for export. Another antibody rapid test manufactured by the same company Zhejiang Orient Gene Biotech, was used effectively in a large COVID-19 serological survey in Spain.

Julsing-Keyter said the Section 21 authorisation allows SAHPRA to put conditions in place to ensure the rapid test meets principles of safety and performance. Section 21 authorisation is a regulatory mechanism that allows for the import and use of health products that have not yet been registered by SAHPRA.

Spotlight reports that the test will only in fact become available once the Ministerial Advisory Committee on COVID-19 releases its much-anticipated national testing algorithm that will set out how serology test kits are to be used. “The algorithm will tell us the appropriate place, how and when the tests can be used,” said Julsing-Keyter. “Because serology tests cannot be used to diagnose COVID-19, they will be helpful for monitoring and surveillance for serological surveys, epidemiological studies and the identification of hotspots,” she said.

Serology tests analyse blood to detect SARS-CoV-2 antibodies that are formed by the immune system in response to a past infection with the virus. They are useful in picking up evidence that a person had the virus even if they did not show symptoms. The tests are different to the swab or PCR test, used in South Africa, which can tell whether a person is currently infected.

Antibody serology tests, in general, are useful in establishing whether a person has acquired immunity to a virus and is also useful in testing whether or not a vaccine against an infectious disease is working. However, with SARS-CoV-2 virus there is currently not enough evidence to say whether someone will be immune and protected from reinfection even if they have developed antibodies to the virus.

Julsing-Keyter said the specifications for the rapid test kit were adopted from the UK Medicines and Healthcare Products Regulatory Authority, with whom South Africa has a memorandum of understanding. “The UK specifications for sensitivity of the test is 95% and we dropped ours to 85% to accommodate mid-performing tests. The specificity of the test is 98%,” she said.

Spotlight reports that the approval for the Orient Gene COVID-19 antibody (POC) test kit comes amid sharp criticism levelled at SAHPRA by some researchers who have complained that the regulatory body has dragged its heels on approving laboratory-based antibody tests as important “weapons” in the arsenal to fight COVID-19. The accusations were expressed in an opinion piece in the Daily Maverick with the authors saying SAHPRA “is overly cautious” in not allowing serology tests to be used by professional clinical laboratories, and that it is “frightened by the mistakes” some countries have made in buying home-testing point of care finger prick tests as epidemic control tests. They have questioned whether SAHPRA regulators have the necessary expertise to evaluate data or whether they are “just misinformed”.

The report says Julsing-Keyter responded saying SAHPRA had “numerous engagements” with the authors who “work for private laboratories”. She said they sent in data and applied for authorisation for laboratory tests that were illegally imported in terms of the 2017 amendment to the Medicines and Substances Related Act 101 (1965) which regulates medical devices and laboratory diagnostics. “You cannot manufacture, import, export or wholesale without a SAHPRA licence,” she said. “Their laboratory-used kits are illegal.”

She said there has been “a flurry of illegal test kits on the market” adding that she gets six or seven reports daily informing her of more unauthorised kits. This is “totally unacceptable especially when you see the repercussion of tests being used by the wrong person”. She said SAHPRA was “on high alert” for devices that had been approved for export but had not been authorised for use in the country of origin.

Spotlight quotes Julsing-Keyter as saying the specifications are published on the SAHPRA website where the target product profile for authorising an antibody test kit is outlined. “Our process is transparent. Applicants can see what standard is needed to authorise a test kit for use.” Once an applicant had been reviewed, the regulator sends the kits to the National Health Laboratory Service (NHLS) where a battery of tests are run to evaluate the product. “If it passes the specifications, it’s authorised, if not it is rejected,” she said.

Julsing-Keyter said in South Africa test kits for COVID-19 are classified as Class D medical devices meaning that they are high risk products in terms of how invasive they are and their duration of use. Class A would be a wooden tongue stick and Class D would be a hip implant.

Licences for the manufacture or importing of high-risk devices will be given only if evidence is provided that the devices are registered for use in one of six jurisdictions namely the US, Europe, Canada, Australia, Brazil and Japan or if the device has been pre-qualified by the WHO.

Julsing-Keyter said COVID-19 presented a challenge as no Class D test kits for COVID-19 were registered in the six jurisdictions. “Europe initially relied on self-declaration which we could not rely on and the US Food and Drug Administration approach is to accept applications and authorise upfront and as they review, they will recall devices.”

SAHPRA could not do this “kind of retrospective” action as it does not have the capacity “to control it (the process)”. “It’s easier for us to control it upfront and rather release a good product onto the market than allow the market to flourish and then try to pull off non-compliant tests after the fact.”


Full Spotlight report


Daily Maverick opinion piece

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