NADAL GX COVID-19 Ag Test
Manufactured by Zhejiang Greylynx Biotech Co.,Ltd., China
Device identification number
3097
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
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
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.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 03:32:47 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
75.5 AU
Analytical Specificity
99.07 %
False positives
0.93 %
False negatives
3.21 %
Accuracy
98.46 %
Clinical Sensitivity
96.79 %
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