SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method)
Manufactured by Hefei Biohit Healthcare, China - www.biouhan.com
Device identification number
1637
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Fingertip, Lateral flow
Target type
Antibody, IgG, IgM
Antibody type
Monoclonal
Targets
nucleocapsid protein, spike protein
Specimen
Plasma, Serum, Whole blood
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)
Pathogens detected
Anti-Nuclear Antibody, Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Influenza A, Influenza B, Respiratory Syncytial V (RSV)
Lineages detected
B.1.1.529 (Omicron), 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 a single-use rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M(IgM) and Immunoglobulin G(IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, K2-EDTA, and sodium citrate), and whole blood (heparin, K2-EDTA, sodium citrate, and no anticoagulant).
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
14 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
10 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
99.4 % IgG
Accuracy
99.1 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.66 % IgM
Clinical Sensitivity
99.46 % IgG
Clinical Specificity
98.66 % 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