SARS-CoV-2 IgG (Electrochemiluminescence Immunoassay)
Manufactured by Shenzhen Lifotronic Technology Co. Ltd., China - http://en.lifotronic.com
Device identification number
2753
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Fully automated (robot)
Physical Support
Card, Cartridge, Cassette, Chip
Target type
IgG
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Immunoassay for in vitro quantify determination of SARS-CoV-2 IgG antibodies in human serum and/or plasma, which is clinically used for auxiliary diagnosis of coronavirus disease COVID-19.
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
CLIA
Measurement
Quantitative
Time
9 minutes
Subclass
Sandwich
Detection Principle
Electrochemiluminescence
LOD
0.498 AU/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.88 % (3 false positives out of a total of 104 negative specimens)
False negatives
19 false negatives for specimens collected from positive subjects ≥14 days post-symptom
Precision
Evaluated
Accuracy
100 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.04 % IgG
Clinical Specificity
97.12 % IgG
Type of antigen
Spike 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