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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 Antigen Rapid Test Strip

Manufactured by Acon Biotech (Hangzhou) Co., Ltd, China - https://www.aconbio.com/ 

Device identification number
1909
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow, Strip
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Comments
N.A.
Assay Type
Immuno-Antigen
Method
Immunochromatography
Measurement
Qualitative
Subclass
Membrane-based
LOD
160 AU
Crossreactivity
Evaluated
Fp
0.24 ((1 out of 410))
Fn
2.59 ((3 out of 116))
Precision
Evaluated
Accuracy
99.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.4 %
Clinical Specificity
99.8 %
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