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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

MARESKIT

Manufactured by NESAPOR EUROPA SL, Spain - www.mareskit.cat 

Device identification number
2241
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
NA
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
100 (pg/mL)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % Positive Predictive Value 100.00%
False negatives
1.18 % (Negative Predictive Value 98.82%)
Precision
Evaluated
Accuracy
99.05 % (95% CI: 96.21% to 99.92%)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.24 % (95% CI: 83.84% to 99.42%)
Clinical Specificity
100 % (95% CI: 97.22% to 100.00%)
Type of antigen
Nucleocapsid protein

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