Dr. Andrea Julsing-Keyter, SAHPRA’s Senior Manager: Medical Devices and Radiation Control, says they receive d a large number of applications for approval of antibody tests, but many of these were not consistently reliable in their results.
However, the regulatory body has now given the go-ahead for the use of a rapid results test produced by a Joahnnesburg-based company Tip Top Trade.
Zhejiang Orient Gene Biotech is the original manufacturer of the test.
ALSO READ: ANC in Gauteng warns: ‘The Covid-19 storm has arrived’
“This was the first antibody test, which is a finger-prick test…that SAHPRA has authorized for use based on the good performance of this test,” says Julsing-Keyte.
