Mbabane: The South African Health Products Regulatory Authority (SAHPRA) has authorized the use of one rapid, point of care serological test kit.
Eyewitness news reported that COVID-19 antibody tests can now be used as part of the country’s fight against the pandemic. The Health Department and the COVID-19 ministerial advisory committee have drafted the protocol on how the antibody tests can be used.
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.
Seven 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.
The South African health department said It will be important to understand the limitations of antibody testing. These include the following considerations:
Antibodies are usually detected more than 10 days after onset of symptoms or even only during convalescence (recovery).
A negative antibody test result does not reliably rule out prior SARS-CoV-2 infection.
For instance, someone may not generate the antibodies or high enough titres for antibodies to be detected.
A positive antibody test result does not reliably prove prior SARS-CoV-2 infection.
There is known cross-reactivity with other viruses and there may be antibodies already existing in someone’s system that look like COVID-19 antibodies.
The detection of antibodies does not necessarily mean one is immune
For these and other reasons, the Department of Health has recommended the following use for antibody tests in the guidelines
Diagnosis of COVID-19-associated multi-system inflammatory syndrome in children (in these children the PCR test can produce false negative results)
To retrospectively diagnose COVID-19 individuals with occupational exposure to SARS-CoV-2 who have recovered from a COVID-19 compatible illness.
Use of SARS-CoV-2-specific IgG antibodies for epidemiological purposes that is to identify and track the transmission of certain geographical areas or populations- this will be a particularly useful application that will complement our surveillance strategies.
Use of SARS-CoV-2-specific IgG, IgM and/or IgA antibodies as part of scientific studies and clinical trials