A game-changing fast Covid test – which can produce results in 15 minutes and can be done by health workers outside laboratory conditions – has become available in South Africa and will add a powerful weapon to the anti-pandemic armoury.
Roche Diagnostics announced that the South African Health Products Regulatory Authority and National Agency for Food and Drug Administration and Control have recently authorised the SARSCoV-2 Rapid Antigen Test test for sale in South Africa and Nigeria.
The SARS-CoV-2 Rapid Antigen Test is for use in point of care settings for symptomatic and asymptomatic people. This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes.
In addition, it serves as a valuable initial screening test for individuals that have been exposed to SARS-CoV-2 infected patients or a high risk environment. The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers.
Sandra Orta, corporate general manager South Africa and head of management centre Sub-Saharan Africa, said: “As South Africa enters the second wave of infections, it will be critical to provide testing in areas where outbreaks are suspected.”
The test is the 10th addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat Covid-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions which help diagnose and manage Covid-19 during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.
The SARS-CoV-2 Rapid Antigen Test will help to quickly identify people who are infected and allows better patient management, as well as more effective use of healthcare resources.
Thomas Schinecker, chief executive of Roche Diagnostics, said: “As the Covid-19 pandemic persists, healthcare systems remain challenged. Testing continues to be an important focus for many countries.”
Roche’s SARS-CoV-2 Rapid Antigen Test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx. This test is performed by healthcare professionals using a nasopharyngeal swab collected from a patient.
An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen.
In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample and can be offered as a rapid strip test that is performed at the point of care.
If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes.
Antigen tests are not as sensitive as molecular tests that amplify the target viral DNA or RNA sequence. A negative results should be analysed together with additional patient factors, such as Covid-19 exposure history and clinical symptoms.