Biolidics' Covid-19 rapid test kit allowed to be sold in EU

SINGAPORE-BASED cancer diagnostics company Biolidics on Monday said its rapid test kit for Covid-19 is allowed for sale in the European Union (EU).

This was after the test kit obtained confirmation for CE marking, a notification process to the relevant authority which allows the company to market and sell the kit in the EU. Having the CE marking confirms the test kit complies with the relevant EU product safety directives.

Biolidics' rapid test kit is "simple to use and portable" and is "one of the few that combines both the IgG/IgM antibody tests for Covid-19". It may be used as a point-of-care test in a wide range of healthcare settings even by clinical staff not trained in complex clinical laboratory procedures.

However, Biolidics noted that test results are not to be used for confirmatory testing or as a sole basis for diagnosis. They need to be interpreted together with clinical presentation and are to be confirmed with supplementary testing.

Currently, polymerase chain reaction testing is used to confirm patients with Covid-19. The swab test usually requires laboratory specialists and dedicated medical testing equipment. It takes three hours to obtain the result but the accuracy is 99 per cent.

Biolidics disclosed on April 1 that the kit had obtained relevant authorisation for use in the Philippines. The same statement noted that the kit received provisional authorisation on March 27 from Singapore's Health Sciences Authority for use in the city-state. 

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Previously, the company said it was working closely with partner Clearbridge Health to obtain approval from health authorities in Asia - particularly in the Philippines, Malaysia, Indonesia and Hong Kong - for the use of this rapid test kit.

Biolidics shares closed two Singapore cents or 7.3 per cent lower at 25.5 cents last Friday.