SARS-CoV-2 Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay)
Manufactured by Shenzhen Kisshealth Biotechnology Co., Ltd
Device identification number
1817
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Latex
Target
Antibody
Specimen
Serum
Commercial Status
Commercialised
Last Update
03/25/2021 12:12
Assay Type
Immuno-Antibody
Method
Immunoassay
Time
10 minutes
LOD
0.5 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1 % ≤1%
Fn
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