SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma)
Manufactured by CITEST DIAGNOSTICS Inc., Canada - www.citestdiagnostics.com
Device identification number
2400
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), Human Immunodeficiency Virus (HIV), 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 SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human serum, plasma, or whole blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 S-RBD IgG antibodies. Positive results indicate the presence of IgG antibodies to SARS-CoV-2.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
AU 100
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
AU 0.022
False negatives
AU 0.015
Precision
Evaluated
Accuracy
98.2 % IgG ((IgG))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.8 % IgG ((IgG))
Clinical Specificity
98.5 % IgG ((IgG))
Type of antigen
Other
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