Covid-19: Regulatory delays cost South Africa vital pandemic information
Here is why the blood donor seroprevalence results from five provinces are not available
- On Friday 12 February results of a SARS-CoV-2 antibody survey were published but only four provinces were included.
- A bureaucratic delay by the South African Health Products Regulatory Authority, the National Health Laboratory Service or Roche (or some combination of these three organisations) prevented the survey from being carried out in the five other provinces.
- An assay used to to do the tests has been approved for use in one machine, but not in another bigger, faster version of the machine.
- This is despite an application for approval being filed in August.
A deadlock over regulatory approval of an antibody testing machine has cost South Africa crucial information about the spread of Covid-19.
On 12 February the results were published of the South African National Blood Service (SANBS) seroprevalence survey, which tested the blood of nearly 5,000 donors from four provinces: Eastern Cape, Northern Cape, Free State and KwaZulu-Natal.
In early December, we reported that a number of seroprevalence surveys were planned, including the SANBS survey, which had been announced in July 2020, but had not yet started. As reported at that time, the Western Cape Blood Service was a partner to SANBS.
But SANBS is a national blood service — so what happened to testing the Western Cape, Gauteng, North West, Mpumalanga, and Limpopo?
In short, the South African Health Products Regulatory Authority (SAHPRA) has not approved the use of a testing assay on a particular model of machine that is used to process blood from those provinces. This despite the test being submitted for consideration in August.
Roche’s Elecsys Anti-SARS-CoV-2 assay was used on Roche’s cobas e411 platform in the four provinces which produced results. In the five other provinces, the same Elecsys assay would be run on the Roche cobas e801 machine. SAHPRA has approved the assay for the e411, but not the e801.
To put it simply: This is exactly the same assay for two very similar machines. The one machine is simply bigger and faster than the other, and it is for this machine that the assay has not yet received approval.
According to experts familiar with these machines, the reagents (chemicals) used for the two machines are identical but simply have different catalogue numbers.
A survey of international medical literature concerning the use of the e801 machine for SARS-CoV-2 antibody detection suggests that it is highly effective.
So why the holdup?
According to SAHPRA, “The test is currently with the National Health Laboratory Service (NHLS) for in-country validation.”
Only once the NHLS completes its validations, can SAHPRA review the performance of the test and issue final recommendations. SAHPRA also referred us to the NHLS regarding questions about how long this validation has been going on, and when it might be expected to be completed.
In response to GroundUp’s questions, the NHLS told GroundUp that, “the validation process has not really been started”.
“The NHLS wishes to state on record that the test in question was not sent to the NHLS through the correct channels. The company stated that they were going to organise the validation through a sister laboratory in KwaZulu-Natal and then did not come back to the NHLS with a request to oversee the process.
“For this reason, the validation was not performed in line with the SAHPRA requirements and the NHLS has been trying to liaise with the company in question to expedite the process … The NHLS is currently discussing the way forward with the company to see how we, as the NHLS, can assist them to expedite and complete this process.
“Again, the company has not been forthcoming with the requirements for validation. Concerning validations, the NHLS has built a solid record when it comes to expediting validations. However, we cannot validate a test without kits, analysers, and controls.”
But Roche disputes this. In response to GroundUp, the company said: “Roche’s antibody test received conditional approval under Section 21 regulation (emergency use authorisation) from SAHPRA in August 2020. As part of this process, supplied products have to be evaluated by the national reference laboratory for performance in-country. Roche responded fully and timeously with these requirements.”
When SARS-CoV-2 antibody tests were first announced, there was a justifiable hesitancy for approving such tests from SAHPRA, particularly as they could mislead individuals about their exposure to Covid-19. However, the use of antibody tests for epidemiological purposes is quite different to using them for diagnostic purposes – it is one of the only ways to understand at a population level the true spread of the virus. Without such data, we cannot effectively plan vaccine distribution, resource allocation, and other public health decisions.
Whether fault lies with NHLS dragging their feet, Roche’s lack of compliance with NHLS requirements, or SAHPRA failing to expedite this approval, the end result is that we know less than we should about the spread of the pandemic in South Africa.
SAHPRA is not being transparent, couching their hesitancy to provide access to high throughput COVID antibody and antigen tests with non-evidence-based rhetoric about poor test performance and test misinterpretation and abuse. SAHPRA must accept responsibility for delaying access to COVID antigen and antibody tests for South Africa. This is because they misguidedly insist on re-evaluating these tests by repeating validation studies when small and quick verification studies would suffice. Validation studies are usually only done by a test manufacturer to prove that their test measures what they claim it measures. This data is always provided to the regulator when the test is submitted for approval and it does not need to be repeated. Verification studies are controlled by strict criteria outlined by ISO 15189 and the laboratory accreditation body SANAS and must be done by diagnostic laboratories that introduce new tests to ensure that the test works. In an unprecedented move in May 2020, SAHPRA insisted on repeating validations for COVID tests – this is like insisting on repeating phase 3 trials for every COVID vaccine to reach South Africa. This process effectively delays access to quality COVID tests. SAHPRA added to their first mistake by then mandating only one NHLS laboratory (based in Johannesburg) to do all these evaluations for every single COVID antigen and antibody test that comes to South Africa. This laboratory, a research unit, does not conduct any COVID diagnostic tests or have experience with the testing platforms on which the tests are done. Private laboratories proficient in COVID testing having provided more than half of all COVID tests done in the country and offered their facilities and expertise to SAHPRA but they were rejected. SAHPRA’s regulatory stubbornness limits COVID test access and compromises the practice of good laboratory medicine by laboratory medicine specialists who have had to settle for whichever test the one and only inexperienced NHLS validation laboratory decides to prioritise, evaluate and approve.
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