Authorised by the South African Health Products Regulatory Authority, the antibody rapid test kits have arrived in the country with Direct Retail Goods announcing the receipt of the first 10,000 units with another 750,000 on order.
Made by Zheijiang Orient Gene Biotech, the single-prick SARS-COV-2 IgG/IgM rapid tests 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.
In a statement, Direct Retail Goods CEO Graeme Pienaar said: “The arrival of this stock finally signals an additional tool in our country’s war with coronavirus. With 750,000 units on order, we have commenced the process to secure further stock of these test kits, able to relieve the snowballing backlog of diagnostic Covid-19 tests. The factory’s manufacturing capacity is 2 million kits per day, so this announcement may be the additional support that our frontline needs.”
SAHPRA’s CEO, Boitumelo Semete-Makokotlela, previously said: “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.”
This will be limited for use under the national testing protocol only and will partially be recommended to supplement nucleic acid testing for the diagnosis of suspected Covid-19, to identify recent or remote past sars-CoV-2 infections, community screening, or hot spot tracing.
Pienaar maintains: “The moment the national test algorithm is released by the Covid-19 ministerial advisory committee, tests can be distributed,” as “the algorithm will tell us the appropriate place, how and when the tests can be used”.
“Our trusted relationships with well-known pharmacies, clinics and healthcare professional chains will enable us to expedite the distribution of antibody test kit stock. Direct Retail Goods is incredibly excited to be leading the charge in South Africa,” he said.