SARS-CoV-2 Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay)
Manufactured by Shenzhen Kisshealth Biotechnology Co. Ltd., China - http://en.kisshealth.cn/
Device identification number
1817
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Latex
Target type
Antibody
Specimen
Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Method
Immunoassay
Time
10 minutes
LOD
0.5 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1 % (≤1%)
False negatives
0 % None
Precision
Evaluated
Accuracy
96.79 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
96.25 %
Clinical Specificity
97.37 %
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