SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence)
Manufactured by Shenzhen Watmind Medical Co. Ltd., China - http://www.watmind.com
Device identification number
1768
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Automated, Near POC / POC
Physical Support
Card, Lateral flow
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
LOD
80 U/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
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