SARS-CoV-2 Total Ab ELISA
Manufactured by BioMARIC, Belgium - www.biomaric.be
Device identification number
2639
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Semi-automated
Physical Support
Microplate
Target type
Antibody
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
none
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
95 minutes
Subclass
Sandwich
LOD
1.637 IU/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % no false positive detected in 352 negative samples
False negatives
0.8 % (1 false negative observed in 126 PCR-positive samples)
Precision
Evaluated
Accuracy
99.79 % ( (Total Ab))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.2 % (total Ab)
Clinical Specificity
100 % ( Total Ab)
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