Dixion Safetest SARS-CoV-2 Antigen Speichel Schnelltest
Manufactured by Dixion Vertrieb medizinischer Geräte GmbH and Shenzhen Dymind Biotechnology Co. Ltd., Germany - www.dixion.de
Device identification number
2489
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
PEI positive approval in Germany
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
150 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.45 %
False negatives
4.65 %
Precision
Evaluated
Accuracy
96.58 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.35 %
Clinical Specificity
97.55 %
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