Dixion Sars-CoV-2 Antigen Test Kit (Colloidal Gold)
Manufactured by Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd., China - www.dixion.de
Device identification number
2644
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, 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.1.525 (Eta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, C.36
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
PEI approval in Germany and registered in France
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
150 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.59 %
False negatives
2.65 %
Precision
Evaluated
Accuracy
97.9 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.58 % ((91.48%-99.06%))
Clinical Specificity
98.37 % ((94.25%-99.80%))
Type of antigen
Nucleocapsid 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