SD Biosensor tests receive exception for self-diagnosis

The Health Ministry has some obligations to fulfil before the actual introduction of nasal antigen tests for Covid-19 self-diagnosis on the market.

Illustrative stock photoIllustrative stock photo (Source: TASR)

The Slovak Office of Standards, Metrology and Testing (ÚNMS) granted an exception for nasal antigen tests produced by SD Biosensor for self-diagnosis of Covid-19.

The expert commission evaluated the samples of the tests and packages, technical documentation, instruction for their use and other materials for home use and use in schools, companies and other places. The commission recommended that ÚNMS grant the exception, the TASR newswire reported.

State planned tests for home use, but those bought by the ministry cannot be used for it yet Read more 

According to the law, the Office decided to place antigen tests intended for self-testing on the market without conformity assessment.

In the decision, ÚNMS SR listed obligations the Health Ministry should fulfil before the actual introduction of nasal antigen tests for self-diagnosis on the market.

Former Minister Marek Krajčí (OĽANO) bought 35 million antigen nasal tests intended for self-diagnosis. He bought the tests from Siemens, where one test cost €3.50, and from SD Biosensor for €3.70 per test.

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