MD003: Testing for COVID-19

 

MD003: Testing for COVID-19

Download the SAHPRA SOP here.

 

In line with the recommendation of the South African National Institute for Communicable Disease (NICD)1 and the recommendation of the World Health Organization (WHO)2, serological tests that are being offered for the diagnosis of COVID-19 are not suitable for the diagnosis of COVID-19 at the acute stage.

They are not helpful to guide decision making regarding patient management, decisions regarding the need for quarantine, isolation or contact tracing at the point of the pandemic in the country

 

TESTS USED TO TEST FOR COVID-193

 

1. COVID-19 is the disease caused when a person is infected by the novel coronavirus called SARS- CoV-2.

 

2. An in vitro diagnostic test can be performed to determine if a person has been infected with SARS-CoV-2 and therefore has COVID-19.

3. Two different types of in vitro tests are possible:

 

a. Tests that detect the presence of the SARS-CoV-2 virus (molecular tests). These tests are performed on material obtained by means of nasopharyngeal and oropharyngeal swabs.

 

b. Tests that detect antibodies to the SARS-CoV-2 virus (serological tests). These tests are conducted on finger-pick blood samples.

 

 

MOLECULAR TESTS -DETECTING THE PRESENCE OF SARS-CoV-2 VIRUS3 

These tests detect the presence of genetic material (nucleic acids) of the actual SARS-CoV-2 virus. Such tests are good at detecting the virus early in the infection and can detect the virus in a person before they become unwell. 

 

SEROLOGICAL TESTS - DETECTING ANTIBODIES TO THE SARS-CoV-2 VIRUS3 

Serological that can be conducted at the point of care by drawing small finger-prick blood sample, tests are not suitable for the diagnosis of COVID-19, as the period between acute infection and detection of antibodies is unknown at this time. They are not helpful to guide decision making regarding patient management, decisions regarding the need for quarantine, isolation or contact tracing. 

 

 

REGULATORY REQUIREMENTS FOR COVID-19 TEST KITS 

i.  At this time, diagnosis of COVID-19 should be made by means of approved molecular diagnostic tests, not by serological tests. 

ii. The sale of serological tests, whether for self-testing or testing under the supervision of healthcare professional is not advised. 

iii. In South Africa, only companies that are licensed by SAHPRA may manufacture, import or sell diagnostic tests. 

 

 

HOW CAN I GET TESTED FOR COVID-193 

i. All COVID-19 testing must be done using molecular testing, under the supervision of a healthcare professional, by an accredited public or private sector laboratory. 

ii. Please see the SAHPRA website for updates relating to COVID-19 (www.sahpra.org.za). 

iii. Please report any company/individual/website selling COVID-19 serological testing kits to SAHPRA so that the necessary action can be taken in this regard. 

 

 

Download: Media Release: Embargo on Rapid Tests.

In line with the recommendation of the South African National Institute for Communicable Disease (NICD)1 and the recommendation of the World Health Organization (WHO)2, serological tests that are being offered for the diagnosis of COVID-19 are not suitable for the diagnosis of COVID-19 at the acute stage. 

 

 

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