GeneFinder™ COVID-19 IgG/IgM Rapid Test
Manufactured by OSANG Healthcare Co. Ltd., South Korea - http://www.osanghc.com/en
Device identification number
3102
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
Antibody type
Polyclonal
Targets
spike protein
Specimen
Plasma, Serum, Venous whole blood, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), 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
Published article : Positivity of SARS-CoV-2 Antibodies among Korean Healthy Healthcare Workers 1 and 2 Weeks after Second Dose of Pfizer-BioNTech Vaccination
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
Serum IgG 1/128 (Dilution rate), IgM 1/4 (Dilution rate)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3.06 % (Predict Postivie Value : 96.94% (95% CI : 91.38 - 98.95))
False negatives
3.29 % (Predict Negative Value : 96.71% (95% CI : 92.53 - 98.59))
Precision
Evaluated
Accuracy
96.8 % (95% CI: 93.81 - 98.37)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95 % (95% CI: 88.82 - 97.85)
Clinical Specificity
98 % (95% CI: 94.29 - 99.32)
Type of antigen
Spike protein
Notes
Tested total 20 pathogens (No cross-reactivity : 20, Detected : only SARS-CoV).
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