GB SARS-CoV-2 Ab ELISA
Manufactured by General Biologicals Corporation, Taiwan ROC - www.gbc.com.tw/
Device identification number
1586
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
120 minutes
LOD
0.089 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
1.92 %
Precision
Evaluated
Accuracy
98.75 % ((Total antibody))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
100 % ((Total antibody))
Type of antigen
nucleoprotein
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