Covid-19 diagnostic testing was limited to nucleic acid amplification tests (NAATs) at the start of the pandemic.
Because, per the centres for disease control and prevention, Covid-19 NAATs are capable of reliably detecting small amounts of SARS-CoV-2 and are unlikely to return a false negative result.
This essentially means that the virus that causes Covid can accurately be diagnosed by a NAAT.
The use of NAAT tests was only limited to selected settings, including laboratories, to be used by trained personnel.
In October 2020, SAPHRA-approved antigen detection rapid diagnostic tests (Ag-RDT) for use in South Africa. It was employed the address the testing backlog and prioritise urgent clinical needs.
Now more than two years later the South African Health Products Regulatory Authority (SAHPRA) has approved the licence to resell at-home antigen Covid-19 testing kits that were initially reserved for sole use by healthcare professionals.
Johannesburg-based company TipTop Trade was the first in the country to obtain approval for a Covid-19 antibody test.
There are likely to be more licences awarded in the coming weeks as more companies seek and receive approval and go to market after SAHPRA’s initial prohibition of at-home testing.
In contrast to PCR (polymerase chain reaction) tests and NAATs, the antigen test is quicker, relatively cheap, and significantly more effective.
Why at-home testing kits after regulation and infections have declined?
According to Dr Noluthando Nematswerani, director of the Discovery Health Centre for Clinical Excellence: “This is particularly important in the case of a disease like Covid-19 where we have no medicine that directly combats the virus.
“(In addition), we have not yet vaccinated enough people to provide a degree of protection from illness in the community.”
Testing is essential for locating those who have got a disease, advising them to separate themselves and concentrate on their medical needs to stop the transmission of the infection to others.
Driving it home, Dr Hanan Balkhy, a professor of paediatric infectious diseases, asserts that antigen testing kits have been created in such a way that they may be carried out in the field or at the bedside, eliminating the need for complex laboratory settings.
Although they are not as precise as PCR testing, they are nevertheless an extremely valuable tool in the fight against the Covid epidemic.
Considering that the Covid-19 pandemic is under control and containment strategies like wearing masks, and quarantine have been relaxed, there appears to be little reason for people to be buying at-home tests.
However, it’s important to note that even though regulations for Covid-19 have been eased, the virus is still very much still around.
Rapid testing became quite popular before major social events as a way to reduce infection rates. They will be particularly useful, especially during the festive season when large gatherings are anticipated.
Boson Biotech’s Covid-19 antigen tests are the first in South Africa to be FDA-approved for use at home. They are intended to be used on individuals over the age of two who have reasonable grounds to suspect they may have Covid-19.
In the meantime, TipTop Trade sells the tests directly on its website. The cost of the tests is R55 for each test, R275 for a pack of five, and R1 000 for a batch of 20.
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