COVID-19 NAb Rapid Test
Manufactured by Zhejiang Kuaye Biotechnology Co. Ltd., China - www.zjky-bio.com
Device identification number
1966
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow, Strip
Target type
Antibody
Specimen
Plasma, Serum, Venous whole blood, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N.A.
Assay Type
Immuno-Antibody
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
10 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % (0 out of 100)
False negatives
6.25 % ( (5 out of 75))
Precision
Evaluated
Accuracy
97.22 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.75 %
Clinical Specificity
100 %
Type of antigen
Other
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