Veri-Q COVID-19 IgG ELISA Kit
Manufactured by MiCo Biomed Co. Ltd., South Korea - www.micobiomed.com/
Device identification number
2789
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Microplate
Target type
IgG
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
Influenza B
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The VERI-Q COVID-19 IgG ELISA Kit is a microplate based enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to SARS-CoV-2 present in human plasma or serum from patients suspected of COVID-19 infection. The VERI-Q COVID-19 IgG ELISA Kit is intended for use by the clinical laboratory personnel specifically trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures The VERI-Q COVID-19 IgG ELISA Kit is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of oth er laboratory tests.
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
100 minutes
Subclass
Enzyme-linked
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.7 < O.D. < 1.1
False negatives
0.7 < O.D. < 1.1
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
93.4 %
Clinical Specificity
100 %
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