COVID-19 Neutralizing Antibody Test Kit
Manufactured by Surge Medical Inc., China - www.surgemedical.cn
Device identification number
2762
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Card
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
LOD
10 AU/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.6 %
False negatives
0.8 %
Precision
Evaluated
Accuracy
98.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.4 %
Clinical Specificity
99.2 %
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