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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Novel coronavirus neutralizing antibody Rapid Test Device

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

Device identification number
1896
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The Novel coronavirus neutralizing antibody Rapid Test Device is a qualitative product, not applicable to LOD.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
0 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % 371 samples are proven negative of 371 negative specimens,so the false positive percentage is 0%.
Fn
5.27 % (144 samples are proven negative of 152 positive specimens,so the false negative percentage is 5.26%.)
Precision
Evaluated
Accuracy
98.47 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.73 %
Clinical Specificity
99.9 % ((>99.9))

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