dedicio® COVID-19 Ag plus Test
Manufactured by Nal von minden GmbH, Germany - https://www.nal-vonminden.com/
Device identification number
2914
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The dedicio® COVID-19 Ag plus Test is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 viral nucleoprotein antigens in human nasal, nasopharyngeal or oropharyngeal specimens. This test is intended for use as an aid in the diagnosis of infections with SARS-CoV-2.
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
75.5 TCID50/mL
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
<0.01%, 0 out of 431
False negatives
2.9%, 5 out of 172
Precision
Evaluated
Accuracy
99.17%
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.09%
Clinical Specificity
>99.99%
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