Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold)
Manufactured by Shanghai BioGerm Medical Technology Co. Ltd., China - http://en.bio-germ.com/
Device identification number
2167
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
NA
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
10 minutes
Detection Principle
Colloidal gold
LOD
500 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
97.76 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.13 %
Clinical Specificity
99.25 %
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