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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/ 

Device identification number
2104
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza B
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.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
0.4 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2.43 % (COVID: 3 out of 123, Influenza A: 13 out of 78, Influenza B: 15 out of 85)
False negatives
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