iFlash-2019-nCoV Antigen
Manufactured by SHENZHEN YHLO BIOTECH Co. Ltd., China - http://www.szyhlo.com
Device identification number
1169
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Cytomegalovirus (CMV)
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 iFlash-2019-nCoV Antigen 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
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
30 minutes
Subclass
Sandwich
Detection Principle
Chemiluminescence
LOD
120 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.46 % ((1/215))
False negatives
2.94 % ((1/34))
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.1 %
Clinical Specificity
99.5 %
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