• A major laboratory service advertised antibody tests would be commercially available from this past Monday.
• When News24 tried to be tested, the laboratory drew blood - then said the next day the test could not be continued.
• Another major lab service claimed the national regulatory authority had made an "error".

Are Covid-19 antibody tests available in South Africa? Or not?

This question was thrown into confusion late on Tuesday, after News24 received information that legal tests had suddenly been recalled from the market by a top laboratory service. This was just days after the tests were advertised to be legally available, from Monday.

Antibody tests are blood tests which determine whether a person has previously contracted the coronavirus. The test is of vital, potentially life-saving importance, as it enables people to understand whether they may have potentially developed post-virus resilience, or even immunity, against the virus again in future. Or not.

News24 is in possession of an SMS cellphone alert, sent on Saturday, which reads: "Lancet Laboratories is pleased to announce that from Monday 17 August 2020 we are able to perform the SARS-CoV-2 Antibody test following SAHPRA approval.

"The test is charged at R230.00 (cash and medical aid), is performed on a SST tube and the turnaround time is 24 hours. A Lancet Laboratories request form will be shared via email shortly."

SAHPRA is the South African Health Products Regulatory Authority.

This News24 reporter, Murray Williams, who has had sustained exposure to the coronavirus as a frontline news journalist, on Monday obtained a doctor's script to order the antibody test.

On Monday afternoon, he visited Lancet Laboratories at Erin Place in Somerset West, and his blood was drawn.

Williams was told by a nursing sister on duty that Lancet's computer system had been battling to "log" the test, and was asked if he was happy for Lancet to send his test to Ampath – another laboratory services company. Williams agreed - and the test was charged to his personal medical aid account.

When Williams messaged his doctor 24 hours later, to ask about his test results, he was told by his doctor that Lancet had now said their licence had been retracted, so the company was no longer able to continue with the antibody test.

Lancet Laboratories, in response, emailed News24: "SAHPRA recalled approval of SARS-CoV-2 antibody tests just 24 hours after they had issued it, citing the absence of a national testing algorithm as the reason.

"Regrettably, Lancet Laboratories can no longer offer this test until this algorithm is released by the Department of Health."

'Granted in error'

On Tuesday afternoon, News24 came into possession of a letter from PathCare, another of the major laboratory services companies.

Dr John Douglass, CEO of PathCare, wrote on Monday: "Please note that SAHPRA... retracted their approval for offering the laboratory-based Covid-19 antibody testing on 16 August 2020, stating that the approval was granted in error. Unfortunately, until approval is granted, we may not offer antibody testing in our labs."

In response to the confusion above, News24 approached SAHPRA, with an urgent request for clarity.

SAHPRA spokesperson Yuveng Gounden received questions from News24 shortly after 17:00 on Tuesday, and committed to sending a response.

At the time of publication on Thursday, a response had not been received.

Algorithm

Two weeks ago, on 7 August, the Western Cape government announced it would start antibody testing "soon".

On 10 July, City Press reported SAHPRA had approved, for use in South Africa, the first Covid-19 antibody rapid blood test kit.

Dr Andrea Julsing-Keyter, SAHPRA's deputy-director of medical devices, told Spotlight a licence to supply the rapid test kit, called Orient Gene-19, had been granted, City Press reported.

But, she warned the test would only become available once the Ministerial Advisory Committee (MAC) on Covid-19 released its much-anticipated national testing algorithm, which 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."

News24 contacted several laboratories, and were told by several that the "algorithm" referred to above was now being awaited.

In July, in a statement on PathCare's website, Douglass wrote that the National Pathology Group engaged with the regulatory authority on the matter after independent studies were conducted.

Confusion

Douglass said several engagements, submissions and appeals had been made to SAHPRA, the MAC, 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 will keep you updated on any progress as it occurs."

In another apparent confusion around antibody test kits: As at 15:00 on Wednesday, the SAHPRA website contained two "banner news" items.

One announced "Covid-19 Test Kits Authorised for Use by SAHPRA", with the sub-heading: "SAHPRA has just authorised the use of the first serology antibody test kit."

Clicking on this link leads to a Microsoft Excel spreadsheet, which lists three suppliers of such tests.

The second "banner news" item includes the notice: "No serological test for Covid-19 has been approved by SAHPRA at this stage."

The national health department could not be reached for comment on the timeline for release of the algorithm.