Covid-19 (2019-nCoV) Antigen Rapid Test Cassette
Manufactured by Dewei Medical Equipment Co. Ltd., China
Device identification number
2279
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, Antigen, IgG
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Type of Antigen is N-Antigen LOD: See URL for additional information
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
AU 0
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2.94 % ((3 out of 102))
False negatives
2.58 % ((3 out of 116))
Precision
Not evaluated
Accuracy
97.25 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
97.06 % ( (Antigen))
Clinical Specificity
97.41 % ( (Antigen))
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