SARS-CoV-2 Antigen Test Kit
Manufactured by Hubei Jinjian Biology Co. Ltd., China - en.jinjianbio.com/
Device identification number
1759
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Automated
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
115 U/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1 % (1 out of 100)
False negatives
1.35 % (2 out of 148)
Precision
Evaluated
Accuracy
98.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.02 %
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