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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)

Manufactured by Nanjing Vazyme Medical Technology Co., Ltd, China - www.vazyme.com 

Device identification number
1849
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-10-13 05:40:34 CET
Comments
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) is applicable to clinical qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen in human nasal swab, nasopharyngeal swab, oropharyngeal swab in vitro.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
50 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1.12 %
Fn
0 %
Precision
Evaluated
Accuracy
99.81 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.88 %
Clinical Specificity
100 %
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