Point-of-care immunodiagnostic tests for COVID 19

In response to the growing COVID-19 pandemic, multiple diagnostic test manufacturers have developed and begun marketing rapid and easy-to-use devices to facilitate testing for evidence of the infection. These simple test kits are based either on detection of proteins from the COVID-19 virus in respiratory samples (e.g. sputum, throat swab) or detection, in blood or serum, of human antibodies (e.g. IgG, IgM) generated in response to infection.

Therefore, based on current evidence, WHO recommends the use of these new point-of-care immunodiagnostic tests only in research settings. They should not be used in any other setting, including for clinical decision making and patient care, until evidence supporting use for specific indications is available. The NMRA does not issue market authorizations to point-of-care rapid antigen/antibody diagnostic test kits at present.

Molecular (e.g. PCR) testing of respiratory tract samples remains the recommended method for identification and laboratory confirmation of COVID-19 cases.