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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette ( Colloidal Gold Method)

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

Device identification number
1757
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Comments
This kit applied chromatographic immunoassay technology as a blocking detection tool. This kit is intended for the qualitative detection of SARS-CoV-2 neutralizing antibodies in human serum, plasma, or whole blood specimen. This kit is intended for use as an aid in identifying individuals with an adaptive immune response to vaccination or natural infection.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Chromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0 AU
Calibration
Not Evaluated
Crossreactivity
Evaluated
Fp
0 AU
Fn
0 AU
Precision
Evaluated
Accuracy
100 % (neutralizing antibodies)
Reproducibility
Evaluated
Robustness
Not Evaluated
Clinical Sensitivity
100 % (neutralizing antibodies)

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