iFlash-SARS-CoV-2 IgG-S
Manufactured by SHENZHEN YHLO BIOTECH Co. Ltd., China
Device identification number
2697
CE Marking
✓Yes
HSC common list (RAT)
×No
Target type
Antibody
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Herpes Simplex (HSV), Influenza B Victoria, Influenza B Yamagata, Mumps Virus (MuV), Mycoplasma Pneumoniae, Rhinovirus A, Rhinovirus B, Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The iFlash-SARS-CoV-2 IgG-S has obtained the CE marking, and its clinical performance verification and analytical performance verification has also been completed.
Assay Type
Immuno-Antibody
Time
37 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.74 % (2/270)
False negatives
3.08 % (2/65)
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.92 % (IgG-S)
Clinical Specificity
99.26 % (IgG-S)
Type of antigen
Spike 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