Diagnostic Cleared for Covid-19, Other Diseases

Amplidiag Easy system for automated processing of patient samples (Mobidiag Ltd.)

1 Mar. 2021. A single diagnostic test for the virus causing Covid-19 infections and three other respiratory diseases received clearance for marketing in Europe. The Amplidiag RESP-4 test made by molecular diagnostics company Mobidiag Ltd. in Espoo, Finland was granted a CE mark, which authorizes marketing of the device in the 30 countries of the European Economic Area.

Mobidiag is a developer of diagnostic tests for infectious diseases as well as automated platforms for analyzing and reporting the results. The company’s diagnostics are designed mainly for use in medical labs, for high-volume processing or on demand. Much of Mobidiag’s recent work is concentrated on detecting SARS-CoV-2 viruses responsible for Covid-19 infections, but the company’s product line covers diagnostics for respiratory and gastrointestinal infections, as well as sepsis, infections associated with health care facilities, and antibiotic resistance.

The RESP-4 test is a high-volume diagnostic in Morbidiag’s Amplidiag line. The test assesses samples from nasopharyngeal swabs, the now-famous method that collects mucous from the back of the nose for SARS-CoV-2 viruses, as well as influenza A and B, and respiratory syncytial virus, or RSV. All four diseases have similar symptoms and occur more frequently in winter, making them difficult to diagnose by symptoms alone.

Manual or automated processing

The Amplidiag RESP-4 test uses reverse transcription – polymerase chain reaction, or RT-PCR, to analyze the samples. RT-PCR looks for viral RNA signatures in samples, in this case signatures for the four respiratory diseases. The RNA is then reverse-transcribed back into DNA, where Amplidiag RESP-4 tests simultaneously for the four viruses. Mobidiag says labs can run the test manually or on the company’s automated platform. The company says the test can return results from 46 samples in three hours.

Tuomas Tenkanen, CEO of Mobidiag, says in a company statement that the Amplidiag RESP-4 test “is highly relevant to both the traditional flu season and Covid-19. Symptoms caused by these viruses — SARS-CoV-2, influenza A, influenza B, and RSV — can be very similar, and it is imperative that health care professionals are able to rapidly distinguish between them, in order to start the appropriate treatment for the benefit of patients.”

The CE mark, originally abbreviated from the French Conformité Européenne, indicates a product meets technical and quality standards for a specific product group, in this case in-vitro diagnostics. A CE mark clears a product for sale and distribution in the 27 countries of the European Union, as well as Iceland, Liechtenstein, and Norway.

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