COVID-19 S-RBD IgG Antibody Test Cassette (Whole Blood/Serum/Plasma)
Manufactured by Hangzhou AllTest Biotech Co. Ltd., China - www.alltests.com.cn
Device identification number
2327
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Enterovirus A71 (EV-A71), Hepatitis C Virus (HCV), Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV)
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 S-RBD IgG Antibody Test Cassette is a fluorescence immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike(S) protein receptor binding domain(RBD) in human whole blood, serum or plasma specimen.It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2.
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.048 AU
False negatives
0.011 AU
Precision
Evaluated
Accuracy
98.2 % (（Antibody）)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.2 % (（Antibody）)
Clinical Specificity
98.9 % (（Antibody）)
Type of antigen
Nucleoprotein
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