SARS-CoV-2 Antigen Rapid Test Cassette
Manufactured by Merlin Biomedical (Xiamen) Co. Ltd., China - http://www.merlinbio.com.cn/en/
Device identification number
2029
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
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
Comments
BfArM Vorgangsnummer: AT214/20 Certificate TÜV Süd No. Q5 106286 0001 Rev. 00 CE number: BE-CA01/1-16963-00006-IVD
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
160 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5 AU
False negatives
1 AU
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.05 %
Clinical Specificity
98.99 %
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