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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AffiDX SARS-CoV-2 Antigen Lateral Flow Test

Manufactured by Avacta Life Sciences Ltd, United Kingdom - www.avacta.com 

Device identification number
2426
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-12 04:30:41 CET
Comments
spike protein antigen
Assay Type
Immuno-Antigen
Reader Required
No
Measurement
Qualitative
Time
20 minutes
LOD
600 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
% 1 out of 102 confirmed negatives
Fn
% 2 out of 98 confirmed positives (PCR Ct values up to 31)
Precision
Evaluated
Accuracy
98.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 %
Clinical Specificity
99 %
Type of antigen
Other

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