SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold)
Manufactured by Shenzhen Watmind Medical Co. Ltd., China - http://www.watmind.com
Device identification number
1769
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
-
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colorimetry
LOD
150 U/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 %
False negatives
4.85 %
Precision
Evaluated
Accuracy
93.7 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.15 % (for onset of symptoms within 7 days)
Clinical Specificity
99.12 %
Type of antigen
Nucleocapsid protein
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