SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence)
Manufactured by Shenzhen Watmind Medical Co., Ltd - http://www.watmind.com
Device identification number
1768
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Near POC / POC
Physical Support
Card, Lateral flow
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
03/25/2021 10:18
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Fluorescence
LOD
80 U/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1 AU
Fn
9 AU
Precision
Evaluated
Accuracy
96.3 %
Reproducibility
Evaluated
Clinical Sensitivity
97.83 % CT value ≤33
Clinical Sensitivity
90.08 % CT value ≤36
Type of antigen
Nucleoprotein
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