In a move that may boost the country's COVID-19 testing capacity, South Africa's National Health Laboratory Service (NHLS) says it is taking steps to reduce its reliance on "a few" suppliers of COVID-19 testing materials.
In recent weeks, private sector testing numbers in South Africa have consistently been higher than the testing numbers reported by the NHLS (which does testing for the public sector).
Early enthusiasm about the NHLS's strong position to rapidly scale up COVID-19 testing due to existing investments in diagnostic infrastructure for HIV and TB have waned after the country found itself unable to secure adequate test materials from key diagnostic manufacturers.
In a March 2020 press statement on the readiness of South Africa's National Health Laboratory Service (NHLS) to meet COVID-19 testing demands, NHLS CEO, Dr Kamy Chetty, claimed that the laboratory service had capacity to process 36 000 test per day - in large part due to the country's existing investment in Cepheid and Roche's diagnostic infrastructure. Dr Sibongiseni Dhlomo, chair of Parliament's Portfolio Committee on Health, wrote in Bhekisisa in early April that South Africa's investment in GeneXpert diagnostics "would prove a masterstroke a few years later" when a rapid COVID-19 test was approved for use on the platform.
Cepheid's GeneXpert and Roche's Cobas multi-disease PCR diagnostic platforms can be used to diagnose a range of viral and bacterial infections using disease specific test materials produced by the companies. South Africa has over 300 GeneXpert diagnostic machines which can process up to 80 samples in 45 minutes, and 18 Cobas machines, which can process up to 1 056 samples in 8 hours.
Both Cepheid and Roche's diagnostic machines require the use of their own 'proprietary' test materials that are protected through a combination of patents and trade secrets.
Yet, the proprietary nature of much of South Africa's diagnostic infrastructure has arguably proved to be the Achilles heel of its testing strategy, as neither Cepheid nor Roche have been able to supply adequate testing materials to meet demand.
Shortages of test materials from these companies, combined with an overly ambitious community screening and testing programme, have resulted in testing backlogs and slow diagnostic turn-around times for COVID-19 tests, as has been widely reported over the past two months.
South Africa is now seeking to reduce its dependency on Cepheid and Roche for test materials. According to NHLS' spokesperson Mzi Gcukumana "the NHLS has upscaled its capacity on a national level and diversified the testing platforms to remove dependency on a few suppliers".
Gcukamana adds that the NHLS has begun to source test materials that are not platform specific through the recently launched African Medical Supplies Platform (ASMP).
"The NHLS has bought five High-Throughput Automated Extraction and liquid Handling Workstations, 50 000 BGI Nucleic acid extraction kits, and 50 000 BGI Real-Time Fluorescent RT-PCR Kits for Detecting SARS-CoV-2 from the AMSP," says Gcukamana. "All of these items are not platform or equipment specific which allows NHLS to use these products on our existing laboratory equipment."
Besides diversifying its diagnostic infrastructure and sourcing non-platform specific test materials, South Africa might also take additional steps to unlock the full potential of its existing diagnostic infrastructure.
"South Africa should explore options to 'open up' closed diagnostic platforms to enable additional companies to produce test materials in short supply, through licensing and technology transfer arrangements," says Candice Sehoma, Doctors Without Borders' access campaign advocacy officer for South Africa.
"Big companies such as Cepheid should also bear the responsibility to share technologies, data and know-how on a mandatory basis with the right to use and produce to benefit producers in developing countries," she says.
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