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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 +Influenza A/B Test

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

Device identification number
2104
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
Influenza A, Influenza B
Commercial Status
Commercialised
Last Update
2021-07-07 05:23:20 CET
Comments
Limit of Detection: COVID: 2 x 10^2,4 TCID50/mL (virustiter), 0,4 ng/mL (nucleoprotein) Influenza A: A2/Aichi/2/68(H3N2), 2,3×10^3 CEID50/Test* Influenza B: Hong Kong 5/72, 3,5×10^3 CEID50/Test* *CEID50: Chicken Embryo Infectious Dose
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
0.4 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
2.43 % (COVID: 3 out of 123, Influenza A: 13 out of 78, Influenza B: 15 out of 85)
Fn
0 % COVID: 0 out of 161, Influenza A: 9 out of 112, Influenza B: 6 out of 105
Precision
Evaluated
Accuracy
99 % ((over 99 %))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97 % ((COVID); 83,3 %(Influenza A); 82,4 % (Influenza B))
Clinical Specificity
98 % ((COVID); 92 %(Influenza A); 94,3 % (Influenza B))
Type of antigen
Nucleoprotein

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