GLINE-2019-nCoV Ag
Manufactured by SHENZHEN YHLO BIOTECH Co. Ltd., China - http://www.szyhlo.com
Device identification number
1347
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The GLINE-2019-nCoV Ag has obtained the CE marking, and its clinical performance verification and analytical performance verification has also been completed.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
200 AU
Analysis of cross reactivity
Evaluated
False positives
0.75 % ((3/400))
False negatives
3.5 % ((4/114))
Robustness
Evaluated
Clinical Sensitivity
97.37 % ( (95%CI: 92.50% - 99.45%))
Clinical Specificity
99.25 % ( (95%CI: 97.82% - 99.85%))
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