SARS-CoV-2 Neutralizing Antibodies Test Kit
Manufactured by CAS-Envision, China - www.cas-envision.com
Device identification number
2788
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Fingertip
Target type
Antibody
Specimen
Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
10 ng/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.37 % (1/269)
False negatives
2.59 % (3/116)
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.4 %
Clinical Specificity
99.6 %
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