The CSIR says the production of Local COVID-19 Swab Extraction Kits will ensure that they reduce the turnaround time of testing
The Council for Scientific and Industrial Research says South Africa is on track to manufacture its own Coronavirus disease 2019 (COVID-19) sample purification kits in large quantities within six months, thereby creating a steady local supply that will speed up testing and reduce the country’s reliance on international suppliers amid intense global demand.
The CSIR’s Dr Previn Naicker says the technology being developed by his team is open source in that it would generate pure samples from nasal and throat swabs that can be tested for the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA on any platform. The work is being funded by the Department of Science and Innovation, the South African Medical Research Council and the Technology Innovation Agency.
The Council maintains that a reliable local supply of sample purification reagents also addresses the specific problem of patient swabs becoming non-viable for testing because of the lengthy backlogs caused by a lack of reagents. Not only do such long waiting periods compromise test results for individual patients, it compromises the entire disease management process that relies on quarantine along with quick contact tracing and testing.
There are testing facilities that are not running at full capacity because there are not enough diagnostic reagents; the project (Local COVID-19 Swab Extraction Kits) will ensure that we close that gap and reduce the turnaround time of testing.
The CSIR is working with local partners such as ReSyn Biosciences, a spin-off company of the CSIR that will produce magnetic beads for extracting viral RNA from test samples.
Magnetic beads offer the advantage that RNA extraction can be automated. “Every step of the diagnostic process that can be automated makes for better testing,” says Naicker.
As positive cases in South Africa continue to increase at an alarming rate, Naicker says the portion of positive cases in relation to the tests conducted shows that South Africa is under-testing. Experts say the virus will be with us for a long time to come, so Naicker’s team and their local partners plan to optimise the local COVID-19 Swab Extraction Kits within the next two months so that validation (testing on real samples), licencing and regulatory approval by the South African Health Products Regulation Authority (SAHPRA) can take place as soon as possible.
If all goes according to plan, we will have a market-ready kit within six months. Based on the capacity of our local partners, kits for the extraction of a minimum of 5 000 samples can be assembled per day at a certified facility, and we are in discussions with two proposed facilities thus far.
The Production of Local COVID-19 Swab Extraction Kits follows after the CSIR announced at the beginning of July that in collaboration with a number of local partners – had completed work on a local ventilator to be rolled out nationwide to patients showing respiratory distress in the early phase of COVID-19 infection.
The CSIR said the development of the ventilator forms part of government’s National Ventilator Project (NVP) under the auspices of the Department of Trade, Industry and Competition (the dtic), and is supported by the Solidarity Fund. The first batch of ventilators will be provided to state hospitals around the country that are currently experiencing pressure due to the unavailability of equipment to deal with the pandemic.
According to the CSIR, their solution is a Continuous Positive Airway Pressure (CPAP) device that uses an innovative design to provide a mild level of oxygenated air pressure to keep the airways open and, thus, assist with breathing.
The units are non-invasive and fill the need for readily available breathing apparatus, deployed and applied easily – even outside of hospitals if needs be – for intervention in cases where patients are at an early, not-intensive stage of respiratory distress caused by the Coronavirus.
Therefore, the device can be used in both high-tech clinical environments, as well as temporary settings, such as field hospitals and quarantine facilities that have been established across the country to handle rising COVID-19 cases.
Under the project name, ‘CSIR L.I.F.E.’ (Lung Inspiratory Flow Enabler), the system uses standard, hospital-grade oxygen supply, and features easy-to-use, on-device flow gauges to adjust Fraction of Inspired Oxygen in steps of 10% oxygenation.