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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Coronavirus Ag Rapid Test Cassette (Swab)

Manufactured by Van Oostveen Medical B.V., Netherlands - www.romed.nl/en 

Device identification number
1831
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
115 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.34 % (3 false positives / 874 true negative (sum of nasopharyngeal and nasal swab samples))
False negatives
2.19 % (5 false negatives / 228 true positive (sum of nasopharyngeal and nasal swab samples))
Precision
Evaluated
Accuracy
99.42 % (99.42 (antigen-nasopharyngeal), 98.73 (antigen-nasal))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.32 % (98.32 (antigen-nasopharyngeal), 97.25 (antigen-nasal))
Clinical Specificity
99.6 % (99.60 (antigen-nasopharyngeal), 100 (antigen-nasal))
Type of antigen
Nucleoprotein

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