Novel Coronavirus (2019-nCoV) Neutralization Antibody Test Kit (Colloidal Gold Immunochromatography)
Manufactured by Glallergen Co. Ltd., China - www.glallergen.com
Device identification number
2707
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antibody
Targets
non-structural protein NSP6, ORF1a polyprotein, ORF1ab polyprotein
Specimen
Whole blood
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
Novel coronavirus (2019-nCoV) neutralization antibody test kit is a solid phase immunochromatographic assay for the in vitro qualitative detection of neutralization antibodies in human serum, plasma and whole blood after vaccination against 2019-nCoV.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
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
94.44 %
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