Immuno-on COVID-19 IgG Test
Manufactured by OSANG Healthcare Co. Ltd., South Korea - http://www.osanghc.com/en
Device identification number
3105
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge, Lateral flow
Target type
IgG
Antibody type
Monoclonal
Targets
spike protein
Specimen
Plasma, Serum, Venous whole blood, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Epstein-Barr Virus (EBV), Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Varicella Zoster Virus (VZV)
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Semi-qualitative for detection of SARS CoV-2 antibody in human blood
Assay Type
Immuno-Antibody
Self Test
No
Reader Required
Yes
Subcategory
Other ()
Method
Immunoassay
Measurement
Semiquantitative
Time
15 minutes
Subclass
Capture
LOD
PRNT50 853 (CPE 1280) / (Serum, Plasma, Whole blood : 1/32 Titer)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.94%[Predict Positive Value : 98.06% (95% CI: 93.19 ~ 99.47)]
False negatives
1.33%[Predict Negative Value : 98.67% (95% CI: 95.27 ~ 99.63)]
Precision
Evaluated
Accuracy
98.42% (95% CI: 96.01 - 99.38)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.06% (95% CI: 93.19 ~ 99.47)
Clinical Specificity
98.67% (95% CI: 95.27 ~ 99.63)
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