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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method)

Manufactured by BIOHIT HealthCare (Hefei) Co. Ltd., China - www.biouhan.com 

Device identification number
87
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Wash aspirate
Cross-reactivity (pathogens tested)
Anti-Nuclear Antibody, Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Influenza A, Influenza B, Respiratory Syncytial V (RSV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The SARS-CoV-2 IgM/IgG antibody test kit is based on the immunochromatographic method. The SARS-CoV-2 IgM/IgG is detected by SARS-CoV-2 recombinant N protein.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
10 (μg/mL)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
99.1 % IgM
Accuracy
99.4 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.66 % IgM
Clinical Sensitivity
99.46 % IgG
Clinical Specificity
98.46 % IgM
Clinical Specificity
100 % IgG
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