SARS-CoV-2 antigen Immunofluorescence assay
Manufactured by Dianext, Italy
Device identification number
2568
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Semi-automated
Physical Support
Card, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
none
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Detection Principle
Fluorescence
LOD
1000
Calibration
Not evaluated
Analysis of cross reactivity
Not evaluated
False positives
6 AU
False negatives
1 AU
Precision
Evaluated
Accuracy
100 % ((antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92 %
Clinical Specificity
99.26 %
Type of antigen
Membrane protein
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