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 (RAT)
×No
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
spike protein antigen
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Measurement
Qualitative
Time
20 minutes
LOD
600 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
% 1 out of 102 confirmed negatives
False negatives
% 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