Covid-19 Rapid Test Kit
Since the beginning of the COVID-19 pandemic, a number of manufacturers have developed COVID-19 Rapid test kits that are referred to as Serological, Rapid or Point of Care (PoC) tests. They are sometimes referred to as IgG or IgM tests. These rapid and PoC tests (serological) are not intended for diagnosis of acute infections and should not be relied upon for self-testing as they may be interpreted as meaning that someone is not infected with the virus when they may actually be infected already. These tests are designed to be used under the direct supervision of a health care professional in epidemiological surveys.
This is a preliminary screening COVID-19 Rapid test kit. The 2019-nCoV IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti–2019-nCoV virus and IgM anti-2019-nCoV virus in human whole blood, serum or plasma. It is intended for self testing and as a screening test and as an aid in the diagnosis of infection with 2019-nCoV viruses. Any reactive specimen with the 2019-nCoV IgG/IgM Rapid Test must be confirmed with alternative testing method(s).
“It is vital that all COVID-19 tests should be conducted by a health care professional and processed by a certified laboratory to ensure accuracy of decision-making, treatment and advice. The health care professional can also decide on whether to alert the relevant health authorities and conduct contact tracing. This will ensure that authorities can trace infections and take action to stop further spread of the infection. The South African public is reminded that at this stage, the use of serological test kits is not recommended. The public is discouraged from using rapid test kits (serological), claiming that you can test yourself at home or test yourself under the supervision of health care professional to determine whether or not you have a COVID-19 infection. Furthermore, all tests and establishments manufacturing or distributing such tests should be licensed by SAHPRA,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
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