- South Africans can now, for the first time, get tested for Covid-19 at home without visiting a doctor, clinic or testing site.
- An importer has been approved for a home antigen test that will cost as little as R50 per test. It is available immediately.
- Antigen tests are not the gold standard for Covid-19 testing and work best on people who are showing symptoms.
- But for nearly two years, people around the world have used them as a layer of detection and protection, often before social events like holiday gatherings.
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Inexpensive home antigen tests are now available in South Africa, more than two years after they were first approved by the South African Health Products Regulatory Authority (SAHPRA) for use by healthcare professionals only.
SAHPRA granted a license to resell the tests for home use to Johannesburg-based company TipTop Trade, who were the first in the country to gain approval for a Covid-19 antibody test in July 2020. Initially, the company imported a range of products and equipment but has since changed its name to TipTop Medical.
TipTop Trade’s license to sell the tests is presumably the first of many to follow in the coming weeks as more companies seek and win approval, and signals a relaxation of at-home testing by SAHPRA that has been prohibited. until now.
Although polymerase chain reaction (PCR) tests remain the gold standard for accurately confirming a case of Covid-19, antigen tests are cheaper and faster. And for several years now, residents of many countries abroad, including the United Kingdom and the United States, have had access to these, often at no cost.
Although antigen tests are not as good at detecting covid-19 as PCR tests, particularly in asymptomatic people, governments, including South Africa’s, have used them extensively to detect potential cases at points of entry.
Elsewhere, self-assessment has become popular before large social gatherings, particularly those involving elderly relatives, such as birthdays and Christmas. It has also proven useful as other similar illnesses, such as the common cold and flu, have made a comeback after a short hiatus from Covid-19, often with similar symptoms.
However, despite its widespread use cases, SAHPRA has so far refused to allow home Covid-19 testing, despite being recommended by South Africa’s top Covid-19 advisors.
In October last year, SAHPRA communications manager Yuven Gounden told GroundUp that antigen tests “are not useful in guiding decision-making about patient management, decisions about the need for quarantine, isolation or contact tracing.
With the Covid-19 pandemic now considered under control and quarantine, isolation and contact tracing requirements relaxed or long abandoned, there appears to be little reason not to allow people to get tested at home.
Gabi Fisher of TipTop Trade told Business Insider South Africa that getting approval for Covid-19 home tests was “rigorous and [in] terms of the SAHPRA requirements”.
He says the tests they secured underwent performance, usability, and feasibility studies, and created a QR code that leads to an instructional video and guide.
The first Covid-19 antigen tests approved for home use in South Africa are those from Boson Biotech. The US Food and Drug Administration (FDA) approved these tests for emergency use in April 2022.
In particular, the FDA approved the Boson Biotech test for people older than two years “with symptoms of covid-19 within the first 6 days of symptom onset, or people without symptoms or other epidemiological reasons to suspect covid-19” .
In its US approval, the FDA also emphasized that “individuals who test negative and continue to experience Covid-19-like symptoms of fever, cough, and/or shortness of breath may still have SARS infection.” -CoV-2 and should seek follow-up”. Be careful with your doctor or health care provider.
Fisher says they have secured enough stock to supply major pharmacies, and the tests will appear on shelves once order and distribution agreements have been finalized.
Meanwhile, TipTop Trade sells the tests directly through its website.
Sold tests are available individually for R55, in a pack of five for R275 and in a pack of twenty for R1,000.
By way of comparison, in October last year, after intervention by the Competition Commission, local pathology groups agreed to lower the prices of their antigen tests from R350 per test to R150 or less. A year later, many laboratories, doctors and test sites continue to charge the maximum of R150 per test.