Manufacturers behind SA’s struggle to access adequate Covid-19 test materials

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Manufacturers behind SA’s struggle to access adequate Covid-19 test materials
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Like many other countries, South Africa is struggling to access adequate testing materials to scale up the Covid19 testing. Catherine Tomlinson investigates.

Lab employees perform testing on samples for coronavirus at a Covid-19 diagnosis centre in Kocaeli, Turkey. Picture: Kadir Yildiz/Anadolu Agency via Getty Images

The National Health Laboratory Service is currently using diagnostic machines produced by several companies to diagnose Covid-19. But the country is facing challenges in securing an adequate supply of reagents and consumables for running these tests. While our national laboratories can develop their own “home-brewed” or “in-house” reagents based on WHO guidelines, our testing infrastructure does not allow for the use of these reagents at scale.

This is because the specific formulations are protected as trade secrets. Hsiao says under normal circumstances, the use of proprietary commercial reagents is preferable to home-brewed reagents, as they are less labour intensive and allow for testing at scale. PCR tests are the most effective way to diagnose Covid-19 as they detect the virus and can therefore determine whether a person has an active coronavirus infection, unlike antibody tests which look at immune responses to determine if a person has ever been infected.The first stage involves the collection of a sputum or phlegm sample from a patient’s nose or throat. This sample is then sent to a lab for processing in a sterile tube.

Roche and Cepheid tests can only be used on their own diagnostic machines. Seegene tests can be used on Seegene and Bio-Rad diagnostic machines, and Thermofisher tests can be used on Applied Biosystems QuantStudio and Bio-Rad diagnostic machines. Bio-Rad diagnostic machines can also be used to process home-brewed tests.

There is [an] urgent need for greater transparency and accountability of the criteria and mechanisms used by global health actors and by diagnostics companies for allocating available supply of tests.South Africa was the first country to roll-out GeneXpert diagnostics at scale after GeneXpert tests were shown to be effective in diagnosing TB. The country was also a crucial site for the trialling of the diagnostic machines.

The NHLS has not confirmed whether the additional cartridges have arrived, or how many have been received to date.

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