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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 (Self-Testing)

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

Device identification number
2451
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-16 10:14:52 CET
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
160 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.46 % (2 out of 435)
Fn
2.94 % (5 out of 170)
Precision
Evaluated
Accuracy
98.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.1 %
Clinical Specificity
99.5 %
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