- The corona test of the Turku-based company’s mariPOC diagnostic system has received the EU’s CE mark
- Deliveries of a test based on a swab sample for direct detection of the virus have already begun
- mariPOC devices are used in 50 different healthcare facilities in Finland
The Finnish medical device manufacturer ArcDia International Ltd has launched an automated COVID-19 point-of-care test for mariPOC® platform. The CE marked test conforms to the requirements of EU IVD directive and ISO 13485 quality standard. Customer deliveries of the test have started.
mariPOC® is the market leader in automated testing and surveillance of respiratory tract infections in Finland with its 50 installations. Because of its ease of use and short time to results, mariPOC® is ideal for decentral-ized rapid testing of acute infections in primary care and emergency clinics.
“The automated rapid test developed by ArcDia is clearly the most efficient and accurate solution on the market for testing COVID-19 in primary care and emergency clinics”, says Dr. Janne Koskinen, Head of R&D at ArcDia ‒
“The tests are performed at the site of sampling, so most of the positive findings are obtained immediately. This is an important advantage over PCR tests where you have to wait up to a cou-ple of days for the result“, Jenna Mäkilä, Product Manager at ArcDia says.
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 analyse 300 COVID-19 samples a day. This capacity is high enough for most outpatient and emergency care units to test all COVID-19 suspected patients.
“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 mariCloudTM 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.
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. Rapid dip-stick tests already on the market are based on measuring antibodies in a blood sample and do not work until two weeks after infection. Antibody tests are not suitable for detection of the acute phase of the disease, but they can be used for determining whether the patient has had the disease in the past. PCR gene testing is slow and not available for testing large numbers of patients in primary care. In addition, PCR tests may give positive results even weeks after the patient is no longer infectious.
ArcDia International Oy Ltd develops, manufactures and markets mariPOC® worldwide. The company in Turku, Finland, was founded in 2008 and employs 30 professionals. mariPOC® products enable central laboratory level quality, performance and pathogen coverage for primary health and emergency care units. ArcDia aims to expand the mariPOC® product line to cover all common infections and antimicrobial resistance
markers.
For more information about the test visit company website arcdia.com