South Africa
#Covid19 antibody tests approved for South Africa─── 10:48 Tue, 25 Aug 2020
Covid-19 antibody tests can now be used as part of the country’s fight against the pandemic.
The South African Health Products Regulatory Authority (SAHPRA) has authorised the use of one rapid, point of care serological test kit.
Five lab-based antibody tests were also given the green light.
The Health Department and the COVID-19 ministerial advisory committee have drafted the protocol on how the antibody tests can be used.
Six businesses have been licensed to distribute the tests, which are made in China.
One of the companies is Tip Top Trade, the firm’s Mendy Sachi.
“SAHPRA has come up with the document, the MD21, which is now essentially coming up with the uses of the kit and where the kit can be used in the country. It’s nice because now that it's opened, we can start moving the kit out and start selling it.”
Another of the companies involved is Direct Retail Goods.
The company’s Graeme Pienaar said they were proud to be distributing a new tool in the fight against the virus.
“We are allowed to supply medical professionals with an additional to supplement PCR analysis tests, so laboratories and medical professionals that have had suspected patients, are able to use an antibody test to aid the diagnosis of COVID-19.”
Tests will not be available to the general public for self-testing and would have to be administered by a registered healthcare professional.
The results of all the tests must be recorded and reported to the National Health Laboratory Service.
