Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal gold immunochromatography)
Manufactured by Glallergen Co. Ltd.
Device identification number
2695
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Card, Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The product is listed by BfArM with AT755/21 ,and has positive results by PEI.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.98 %
False negatives
5.56 %
Precision
Evaluated
Accuracy
96.67 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.44 %
Clinical Specificity
99.02 %
Type of antigen
Nucleocapsid protein
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