VTRUST SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody)
Manufactured by TaiDoc Technology Corp., Taiwan ROC - https://taidoc.com/
Device identification number
2702
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow, Strip
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N/A
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
≦1%
False negatives
≦6.7%
Precision
Evaluated
Accuracy
≧97.7% (IgG)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
≧93.3% (IgG)
Clinical Specificity
≧99.0% (IgG)
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