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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



mariPOC SARS-CoV-2

Manufactured by ArcDia International Ltd, Finland - www.arcdia.com 

Device identification number
768
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Automated, Near POC / POC
Physical Support
Cartridge
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab, Other
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), MERS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
No crossreactivity with MERS, seasonal coronaviruses (229E, HKU1, NL63, OC43) or other common respiratory tract pathogens or normal bacterial flora. The test is designed to escape SARS-CoV strain variations. It detects so conserved epitope that it is shared also by SARS-CoV(-1) from year 2003.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Semiquantitative
Time
20 minutes
Subclass
Sandwich
LOD
2.7 AU
Crossreactivity
Evaluated
Fp
0 % no
Fn
0 % no
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Type of antigen
Nucleocapsid protein
Notes
https://www.nature.com/articles/s41598-021-99886-6

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements