Ninonasal-Autotest
Manufactured by NG Biotech, France - https://ngbiotech.com/
Device identification number
2281
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal 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.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), 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
Updated list of variants
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Membrane-based
LOD
1 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.51 (2 false positive result out of 390 negative samples confirmed by RT-PCR))
False negatives
2.34 % (3 false negative results out of 128 positive samples confirmed by RT-PCR)
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
98 %
Clinical Specificity
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