GLINE-2019-nCoV Ag (Self-test)
Manufactured by SHENZHEN YHLO BIOTECH Co. Ltd., China
Device identification number
2891
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), 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
The conformity assessment procedure of self-testing has been successfully completed, and we have obtained the EC Certificate of YHLO’s rapid antigen test product GLINE-2019-nCoV Ag (self-test). It is also listed on the Ministry's platform in France.
Assay Type
Immuno-Antigen
Reader Required
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
200 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.44 % (1/227)
False negatives
3.62 % (5/138)
Precision
Evaluated
Accuracy
98.36 % (95%CI: 96.46% - 99.39%)
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
96.38 % (95%CI: 91.75% - 98.81%)
Clinical Specificity
99.56 % (95%CI: 97.57% - 99.99%)
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