2019-nCoV IgM/IgG Antibody Test Kit（Colloidal Gold）
Manufactured by Biobase Biodustry（Shandong） Co. Ltd., China - https://www.biobase.cc/
Device identification number
2895
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
Targets
envelope protein, membrane protein, non-structural protein NSP1, nucleocapsid protein, spike protein
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The SARS-COV-2 IgM/IgG Rapid Test Kit is used for the qualitative detection of IgM and IgG antibodies in human serum, plasma or whole blood.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
5 ng/mL (IgG )
LOD
25 ng/mL (IgM)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.67 %
False negatives
1.85 %
Precision
Evaluated
Accuracy
98.33 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.15 %
Clinical Specificity
98.44 %
Type of antigen
Nucleocapsid protein
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