Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal gold immunochromatography) - Saliva
Manufactured by Glallergen Co. Ltd., China - www.glallergen.com
Device identification number
2802
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
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 - Oral saliva specimen collection - is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. The test uses SARS-CoV-2 antibody (test line T) and goat anti-mouse IgG (control line C) immobilized on a nitrocellulose strip.
Assay Type
Immuno-Antigen
Reader Required
Yes
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
9.65 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
not allowed
False negatives
Improper preparation, mutant strains, virus in the samples below detection limits
Precision
Evaluated
Accuracy
96.19 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.52 %
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