SARS-CoV-2 IgG (Chemiluminescent Immunoassay)
Manufactured by Suzhou Hybiome Biomedical Engineering Co., Ltd., China - https://www.hybiome.com/
Device identification number
2042
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Lab-based
Physical Support
Other
Target
Antibody, IgG
Specimen
Plasma, Serum
Pathogens detected
Adenovirus, Anti-Nuclear Antibody, Chlamydia Pneumoniae, Hepatitis C Virus (HCV), Influenza B, Mumps Virus (MuV), Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
S-RBD, physical support= magnetic microparticles
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
CLIA
Measurement
Qualitative
Time
60 minutes
Detection Principle
Chemiluminescence
LOD
0 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.1 % IgG
Fn
0.6 % IgG
Precision
Evaluated
Accuracy
99.1 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.4 % IgG
Clinical Specificity
98.9 % 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