Biolidics has received product authorisation from Indonesia’s ministry of health for the usage and distribution of the company’s ClearEpi SARS-CoV-2 Antigen Rapid Test Kit (ClearEpi ART) in Indonesia.
In a filing to SGX dated March 15, the company states that the authorisation remains valid until March 10, 2022, and the extension of its validity may be permissible should there be no undesirable events upon usage.
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.
