CAPE TOWN- The South African Health Products Regulatory Authority (SAHPRA) have authorised the
of Covid-19 antibody rapid test kits in the country with Direct Retail Goods
announcing the receipt
of the first 10 000 units, and another 750 000 on order.
The single-prick serologic test detects the presence of antibodies in your blood, but cannot detect the coronavirus itself.
When the body’s immune system responds to a virus, various different types of antibodies are produced to fight the infection. These antibodies are useful in picking up evidence that a person had the virus even if they were asymptomatic.
Chief Executive Officer of SAHPRA, Boitumelo Semete-Makokotlela said in a
communication to stakeholders
last month the tests, made by Zheijiang Orient Gene Biotech, meet the target product profile under Section 21 authorisation.
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Direct Retail Goods CEO, Graeme Pienaar, said the arrival of the antibody test kits signals an additional tool in the 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,” he said.
Semete-Makokotlela said only SAHPRA licence holders who are authorised to manufacture or distribute the test kits are eligible to receive Section 21 authorisation.
"The tests 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,” she said.
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