Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold)
Manufactured by Nanjing Norman Biological Technology Co. Ltd., China - https://www.normanbio.com
Device identification number
2506
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The Antigen Test cassette is used for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human Oropharyngeal swabs, Anterior Nasal swabs, or Nasopharyngeal swab in vitro.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colloidal gold
LOD
121 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.71 % (Nasopharyngeal swab)
False positives
0.77 % (Anterior Nasal swab)
False negatives
6.79 % (Nasopharyngeal swab)
False negatives
6.98 % (Anterior Nasal swab)
Precision
Evaluated
Accuracy
97.61 % (Nasopharyngeal swab)
Accuracy
96.76 % (Anterior Nasal swab)
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
91.13 % (（Saliva）)
Clinical Sensitivity
93.02 % (Anterior Nasal swab)
Clinical Sensitivity
93.21 % (Nasopharyngeal swab)
Clinical Specificity
93.02 % (Anterior Nasal swab)
Clinical Specificity
99.23 % (Anterior Nasal swab)
Clinical Specificity
99.29 % (Nasopharyngeal swab)
Type of antigen
Nucleocapsid protein
Notes
https://www.normanbio.com/novel-coronavirus-2019-ncov-antigen-testing-kit-colloidal-gold_p8.html
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