Late last year the South African Health Products Regulatory Authority (Sahpra) approved antigen tests that can be used at home.

Sahpra has approved seven Covid-19 antigen self-test kits for self-test or at-home tests. The approved tests are from Humor Diagnostica (Pty) Ltd, IDT Diagnostics t/a ICT International, Mnandi Pharma Solutions (Pty) Ltd, Rapid Testing Solutions SA (Pty) Ltd, TipTop Trade (Pty) Ltd, Rapid Testing Solutions SA (Pty) Ltd and Pro Med Diagnostics (Pty) Ltd.

“This Sahpra authorisation allows organisations that received approval to market and sell the self-test kits to the public. These test kits can be [bought] at any pharmacy,” Sahpra explained in its statement.

There are some things that those using self-tests should know, the regulator said:

It is essential to follow instructions.

If a self-test produces a positive result, you should go for a polymerase chain reaction (PCR) test, which is a laboratory test, to confirm the result.

A negative test doesn’t necessarily mean that you do not have Covid-19. If you have symptoms, you should go for a laboratory test.

A Covid-19 self-test kit. (Photo: Supplied)

“These test kits offer a quick and viable alternative for Covid-19 screening. Performance testing was done in collaboration with our National Reference Laboratory [the National Health Laboratory Service or NHLS] to ensure that quality test kits are available to the public. Sahpra always ensures public safety when approving any health product,” Sahpra CEO Dr Boitumelo Semete-Makokotlela said.

How do you use a self-test?

The test consists of a swab to take a sample from the nose, as well as testing liquid. There are instructions in the packet on how to do the test, and the leaflet also explains how to dispose of the test after obtaining a result. The test does rely on viral load, so it is best used within five to seven days of the onset of symptoms.

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What is an antigen?

An antigen, in this case, is a protein in the Sars-CoV-2 virus that triggers an immune reaction in the human body. For these tests, it is a protein that can be found on the surface of the virus.

What is the difference between an antigen test and a PCR test?

A PCR test is the “gold standard” for a Covid-19 infection, as it is the most sensitive of tests. However, results can take longer, especially when dealing with massive outbreaks.

What about an antibody test?

This is better for people who wish to identify if they have had an infection in the past. It is not used to diagnose a new Covid-19 infection.

What is the current Covid-19 situation in South Africa?

The National Institute for Communicable Diseases reported a 14.2% increase in new positive Covid-19 cases in the past week, but the numbers are still relatively low, with 1,781 new cases.

The highest incidence of Covid-19 infections was in the Western Cape at 12.9/100,000, followed by the Eastern Cape at 2.2/100,000.

The other provinces reported a case incidence rate of below 2/100,000.

According to the latest wastewater report, scientists found “intermediate” levels of virus particles in the country’s wastewater systems.

The virus particles found were from Omicron lineages BE.8, XBB.1.5, BE.1.1, BQ.1.1.20, CH.1.1, BE.7, and BA.5.11.

In their latest report, South African teams tracking possible virus mutations stated that Omicron is still the dominant variant. BQ.1 is the dominant subvariant.

XBB.1.5, named the Kraken Omicron by the international media, was detected in two samples taken in December 2022 and 77 taken in January this year. DM168

This story first appeared in our weekly Daily Maverick 168 newspaper, which is available countrywide for R25.