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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



mariPOC Respi+

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

Device identification number
2078
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
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Beta Coronavirus OC43 (HCoV-OC43), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, SARS-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 SARSCoV(-1) from year 2003. Most positive results are reported in 20 minutes. Low positive and negatives are reported in 120 minutes. Please update the link of the scientific publication in the online database to https://www.nature.com/articles/s41598-021-99886-6 since the article has now been peer reviewed and published.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Semiquantitative
Time
120 minutes
Subclass
Sandwich
LOD
2.7 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 % No false positives
Fn
0 % No false negatives
Precision
Evaluated
Accuracy
100 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % ( (Antigen))
Clinical Specificity
100 % ( (Antigen))
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