MAVERICK CITIZEN: Antibody testing – the missing weapon in the fight against Covid-19 in South Africa

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MAVERICK CITIZEN: Antibody testing – the missing weapon in the fight against Covid-19 in South Africa
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The global SARS-CoV-2 pandemic and Covid-19 disease have challenged humanity in many ways. It has also changed the health profession. One example is how laboratory professionals, clinicians, scientists and technical staff moved from their usual role of providing ancillary information to primary clinicians and public health experts to centre stage. This is because laboratory tests are essential for the control of this pandemic, contributing to case identification, isolation, contact tracing, and rationalisation of infection control measures.

Nucleic acid amplification tests are currently the gold standard for the diagnosis of SARS-CoV-2 infection. Within weeks of the first cases in Wuhan, NAAT tests – specifically real-time Polymerase Chain Reaction tests – were developed by laboratories of the World Health Organisation as well as the China and US centres for disease control public health agencies.This was possible because of the dramatic achievement of quickly sequencing the genetic material of SARS-CoV-2, a new virus in humans.

Most importantly however, is that RT-PCR tests are complex and expensive, requiring skilled laboratory staff with the relevant experience and equipment to conduct them. Each of the processes necessary to amplify the detected viral material in the lab is vitally important.

There was a push to do community-based testing using teams that visited and tested entire households regardless of contacts or symptoms. The volumes and logistics required to do this was completely unsustainable and not useful as a public health intervention. From a public health perspective, this type of testing also skewed the number of cases that could be identified. Cases were only equal to the number of people that managed to get a test, shifting the whole focus of the classic public health intervention of testing to identify cases, isolate and trace and test their contacts, and erroneously defining the number of tests done as the number of cases.

Clinical laboratories are familiar with high throughput immunoassays, and they are used all the time to assist with the diagnosis, management and public health interventions for viral infectious diseases.A familiar example is an HIV ELISA test. HIV serology tests have a window period of 21 days – that is, they only detect antibodies 21 days after exposure to HIV.

Antibody tests were made using purified proteins to detect SARS-CoV-2 antibodies of various types . Usually with viral infections, IgM antibodies can be detected by tests early after viral infections, followed by IgG antibodies that signify recovery and immunity. But this pattern has not been seen with SARS-CoV-2, and both IgM and IgG appear to occur simultaneously after infection becoming detectable on day 14.

Finally, SARS-CoV-2 antibody testing is the only end-point measurement to confirm that SARS-CoV-2 vaccines work. Without these tests the trials that have started throughout the world and with much fanfare in South Africa will be a waste of time and money. Also, SARS-coV-2 antibody testing is crucial to identify donors of convalescent plasma that is used to assist severely ill Covid individuals who have not responded to other treatments.

But, we believe, this caution has unfortunately paralyzed SAHPRA’s consideration and approval of properly evaluated tests to be used by professional certified and accredited clinical laboratories.

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