• South Africans can now, for the first time, test themselves for Covid-19 at home without visiting a doctor, clinic, or testing site.
  • One importer has secured approval 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 in people showing symptoms.
  • But for nearly two years, people worldwide have used them as a layer of detection and protection – often before social occasions like end-of-year gatherings.
  • For more articles go to www.BusinessInsider.co.za.

South Africans can now, for the first time, test themselves for Covid-19 at home without visiting a doctor, clinic, or testing site.
One importer has secured approval 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 in people showing symptoms.
But for nearly two years, people worldwide have used them as a layer of detection and protection – often before social occasions like end-of-year gatherings.
For more articles go to www.BusinessInsider.co.za.

The license for TipTop Trade to sell the tests is presumably the first of many that will follow in subsequent weeks as more companies seek and gain approval – and signals a relaxing 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 Covid-19 case, 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, they’ve been widely used by governments, including South Africa’s, to detect possible cases at points of entry.

Elsewhere, self-testing has become popular ahead of large social gatherings, particularly those that involve elderly family members, like birthdays and Christmas. It has also proven useful as other similar illnesses like the common cold and flu have returned after a brief Covid-19 hiatus, often with similar symptoms.

Yet despite their widespread use cases, SAHPRA has until now declined to allow at-home Covid-19 testing – despite South Africa’s top Covid-19 advisors recommending it.

In October last year, SAHPRA communications manager, Yuven Gounden, told GroundUp that antigen tests are “not helpful to guide decision-making regarding patient management, decisions around the need for quarantine, isolation or contact tracing.”

With the Covid-19 pandemic now considered under control and requirements for quarantine, isolation, and contact tracing relaxed or long abandoned, there appears little reason not to allow people to test at home.

TipTop Trade’s Gabi Fisher told Business Insider South Africa that obtaining approval for the at-home Covid-19 tests was “rigorous and [in] terms of SAHPRA’s requirements”.

He says the tests they secured underwent performance, usability, and feasibility studies, and they have created a QR code that leads to an instructional video and guide.

The first of the Covid-19 antigen tests approved for home use in South Africa are those by Boson Biotech. The United States Food and Drug Administration (FDA) approved these tests for emergency use in April 2022.

In October last year, SAHPRA communications manager, Yuven Gounden, told GroundUp that antigen tests are “not helpful to guide decision-making regarding patient management, decisions around the need for quarantine, isolation or contact tracing.”

With the Covid-19 pandemic now considered under control and requirements for quarantine, isolation, and contact tracing relaxed or long abandoned, there appears little reason not to allow people to test at home.

TipTop Trade’s Gabi Fisher told Business Insider South Africa that obtaining approval for the at-home Covid-19 tests was “rigorous and [in] terms of SAHPRA’s requirements”.

He says the tests they secured underwent performance, usability, and feasibility studies, and they have created a QR code that leads to an instructional video and guide.

The first of the Covid-19 antigen tests approved for home use in South Africa are those by Boson Biotech. The United States Food and Drug Administration (FDA) approved these tests for emergency use in April 2022.

Fisher says they have secured enough stock to supply leading pharmacies, and tests will appear on shelves once they have finalised order and distribution agreements.

In the interim, TipTop Trade is selling the tests directly via its website.

The tests sold 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 from the Competition Commission, local pathology groups agreed to drop the prices of their antigen tests from as much as R350 per test to R150 or less. One year later, many laboratories, doctors, and testing sites continue charging the maximum of R150 per test.

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