COVID-19 antibody rapid test kits support President's bid to determine the real virus infection rate

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As South Africa eases into lockdown level 1, further relaxing restrictions, many believe that the COVID-19 pandemic is far from over. The accurate number of positive COVID-19 cases remains uncertain, despite the number shared on the Department of Health's WhatsApp group. The discrepancy between that number and predictions made by professional data modellers is significant and continues to create confusion and controversy.

The Department of Health recently approved a new weapon in the war against the virus, which will assist in determining the country's real infection rate. President Cyril Ramaphosa explained: "We will be undertaking a nationwide survey to assess the actual levels of infection within society. The survey, known as a seroprevalence survey, uses antibody tests to see if a person has been exposed to the coronavirus."

The distributor of the single-prick SARS-CoV-2 IgG/IgM rapid test kits, Direct Retail Goods CEO, Graeme Pienaar, added, "We have procured and landed the stock – authorised by South African Health Products Regulatory Authority (SAHPRA) – we have received the NICD Verification to dispense the stock immediately to all healthcare professionals, clinics, medical facilities and workplaces. This means we are geared up to assist research facilities and scientists with the national sero-survey study to understand how many people have been infected truly."

He adds, "We have been inundated with requests for available stock, we urge all stakeholders from the private and public sector to reach out to us, we are delighted now that it can be full steam ahead to help the government and healthcare professionals get a clear picture of where we are in this war with COVID-19."

"Direct Retail Goods provide the required temperature control certificate validating that the stock has been protected throughout the supply chain, together with lot-to-lot verification from the NICD, which healthcare professionals are encouraged to ask for. To expedite the process, we assist customers in loading users and buyers on the NHLS database and can supply value-added training support, needles, and alcohol swabs. In this complex challenge, the healthcare industry needs partners that can make it easier on them."

Made by Zhejiang Orient Gene Biotech, test kits analyse blood to detect SARS-CoV-2 antibodies that are formed by the immune system in response to a past infection with the virus. They are useful in picking up evidence that a person had the virus even if they were asymptomatic and were used effectively in a large COVID-19 serological survey in Spain.

SAHPRA information
In a 22 July communication to stakeholders, Boitumelo Semete-Makokotlela, CEO of SAHPRA, explained, "COVID-19 serological tests do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection. Serological tests are not appropriate for clinical diagnosis of COVID-19. SAHPRA has, however, taken the position (md005) to authorise the COVID-19 serology tests that meet the target product profile (md007) under section 21 authorisation. It will be limited for use under the national testing protocol only and is recommended to supplement nucleic acid testing for the diagnosis of suspected COVID-19, to identify recent or remote past sars-CoV-2 infections, targeted cohort surveillance, community screening, specifically for serosurveys or hot spot tracing, population-level epidemiologic studies and surveillance programmes, identification of convalescent plasma donors, and as part of scientific research studies."

SAHPRA material

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