NG-Test SARS-CoV-2 Ag
Manufactured by NG Biotech, France - https://ngbiotech.com/
Device identification number
1646
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), SARS-CoV
Pathogens detected
SARS-CoV
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Information on antigen epitope targeted by the antibodies used in the design of the device
Target epitope (amino acid position) : 44-55 (linear)
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), Other (BA.4,BA.5), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-10-05 01:56:28 CET
Comments
Update of performances with additional data
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
1 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
0.33 % (1 false positive out of 305 negative samples confirmed by RT-PCR)
False negatives
24 % (29 false negative results out of 121 positive samples confirmed by RT-PCR)
Precision
Evaluated
Accuracy
95.3 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
92 % (for Ct <30)
Clinical Sensitivity
97.5 % (for CT < 25)
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