Novel Coronavirus (2019-nCov) Antigen Test Kit (Colloidal Gold immunochromatography)- Lolly Pop
Manufactured by Glallergen Co. Ltd., China - www.glallergen.com
Device identification number
2777
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, 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 COVID-19 Antigen Rapid Test Kit is intended for in vitro qualitative detection of 2019-nCoV nucleocapsid antigens in oral saliva specimen from individuals who are suspected of COVID-19.
Assay Type
Immuno-Antigen
Reader Required
Yes
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
9.65 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
False positive is not allowed
False negatives
Improper operation procedures, below limits detection, mutant strains, disease stage
Precision
Evaluated
Accuracy
96.67 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.59 %
Clinical Specificity
99.02 %
Type of antigen
Nonstructural protein NS6
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