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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 Oy Ltd, Finland - https://www.arcdia.com/ 

Device identification number
2078
CE Marking
✓Yes
HSC common list
✓Yes
HSC mutual recognition
✓Yes
Format
Automated, Near POC / POC
Physical Support
Cartridge, Other
Target
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
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
Commercial Status
Commercialised
Last Update
2021-11-17 03:50:22 CET
Comments
mariPOC Respi+ multianalyte test includes mariPOC SARS-CoV-2 test reagents Clinical validation data: https://www.medrxiv.org/content/10.1101/2021.02.08.21250086v2. Other linkages detected: B.1.617.2 (Delta variant)
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
120 minutes
Subclass
Sandwich
LOD
AU 2.7
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
Nucleoprotein
Notes
“No cross-reactivity with with MERS, seasonal coronaviruses (229E, HKU1, NL63, OC43) or other common respiratory tract pathogens or normal bacterial flora.

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