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Finnish coronavirus test receives CE Mark

ArcDia

The CE marked automated COVID-19 point-of-care test conforms to the requirements of EU IVD directive and ISO 13485 quality standard.

The new coronavirus test is available both as part of an extensive multianalyte mariPOC Respi test panel identifying 11 common pathogens and as a single target test enabling high-capacity rapid testing, for example at airports or workplaces. The mariPOC Respi panel provides diagnosis and enables appropriate treatment also for patients with a viral or bacterial disease other than COVID-19. A single bench-top analyser can automatically analyze 300 COVID-19 samples a day, states the company. This capacity is high enough for most outpatient and emergency care units to test all COVID-19 suspected patients, it states.

Looking for strategic partners

“mariPOC tests are affordable compared to PCR tests and can be performed for much larger number of patients. The test results are automatically transferred to ArcDia’s mariCloud service, providing a comprehensive real-time epidemiological picture for the use of authorities and health care professionals. Such data is key in infection surveillance and in creation and implementation of strategies to fight the pandemic,” says Vesa Kemppainen, ArcDia’s CEO.

Customer deliveries have now started and ArcDia is looking for new international distribution partners and a strategic partner for entering the US market.

Ready in 20 minutes

The rapid mariPOC test is based on the direct detection of infectious virus from a swab sample. The method is ideal for diagnosing the acute phase of the disease and assessing patient infectivity.

“A sample is taken from the patient’s nose with a swab. The swab is cut into a test tube. The tube is filled with liquid and put into the analyzer. The results are ready in 20 minutes. The patient will have a name for his/her disease and correct medication and treatment before he/she leaves the hospital or clinic. Our test reduces unnecessary use of antibiotics as well. The results are automatically sent to our cloud service for epidemic surveillance, i.e. test results are visualized on map. The Finnish health authorities THL use this map already,” describes Kemppainen.