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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



NADAL® COVID-19 Ag Test (self-testing)

Manufactured by Nal von minden GmbH, Germany - https://www.nal-vonminden.com/ 

Device identification number
2848
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow, Other
Target type
Antigen
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The NADAL® COVID-19 Ag Test detects components (viral nucleocapsid protein) of the COVID-19 pathogen SARS-CoV-2, and is intended for use in the qualitative detection of the virus. Samples are comprised of nasal secretions taken from the lower nasal passage (anterior nasal swab), which are collected with the help of the swab provided. The test can be used anywhere and is suitable for self-use outside a laboratory environment. A positive result provides a first indication that an infection is present and that there is therefore a risk of transmission to others.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
0.4 ng/mL
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
5.9 % (6 out of 102 clinical samples with Ct<30)
Precision
Evaluated
Accuracy
97.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.1 % (Ct<30)
Clinical Specificity
99.9 % (>99.9 %)
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