Biolidics notes that antigen rapid test kits such as the ClearEpi ART are different from serology rapid test kits for the detection of Covid-19 antibodies. Serology tests are administered via blood draw and seek to detect antibodies that usually appear in patients during the recovery phase of Covid-19, whereas antigen tests are performed via nasal swab and detect viral proteins in patients during the acute phase of the virus.
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While both serology and antigen tests are quicker and cheaper than polymerase chain reaction (PCR) tests, the company highlights that serology and antigen tests have “lower sensitivity and specificity than PCR tests”. As such, the company states that ClearEpiART test results are only for clinical reference and should not be the only basis for clinical diagnosis and treatment.
The company expects the authorisation to “contribute positively” to revenue for FY2021 ending December 2021, though it is unable to quantify the impact at this time.
Shares in Biolidics closed flat at 28 cents on March 15.