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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)

Manufactured by Hangzhou Realy Tech Co., Ltd, China - www.realytech.com 

Device identification number
2018
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-09-09 09:59:50 CET
Comments
/
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
1250 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % (430 samples are proven negative of 430 negative specimens)
Fn
4.61 % ((9 samples are proven negative of 195 positive specimens))
Precision
Evaluated
Accuracy
98.56 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
95.38 %
Clinical Specificity
99.9 % ((>99.9%))
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