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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Rapid Test Cassette (Colloidal Gold Method)

Manufactured by Wuhan NanoDiagnosis for Health Biotechnology Co., Ltd, China - ndh-biotech.com 

Device identification number
1837
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Comments
LOD is 5x10ˆ2.55TCID50/ml Our rapid test reliably detects the known SARS-CoV-2 mutations VOC-202012/01 (or B.1.1.7, N501Y.V1, or UK variant) and N501Y.V2 (or B.1.351 or South African variant).
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
3581.5 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1.9 % (2 false positives in 105 tests)
Fn
0.6 % (2 false negatives in 331 tests)
Precision
Evaluated
Accuracy
99.08 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.1 %
Clinical Specificity
99.4 %
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