GeneFinder™ COVID-19 Ag Dipstick
Manufactured by OSANG Healthcare Co. Ltd., South Korea - http://www.osanghc.com/en
Device identification number
1593
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Dipstick, Lateral flow, Strip
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV
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), P.2 (Zeta)
Commercial Status
In development
Last Update
2022-08-24 09:08:01 CET
Comments
Nasal Swab -> GeneFinder™ COVID-19 Ag Dipstick Self Test: other linkages detected: BA2.0 (Stealth); antigen_epi Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (detection Ab) Epitope Target : 47-173 Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab) Epitope arget : 44-175
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
750 TCID50/ml (Ct Value (RdRP/S) 27.67)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.04 % (Predict Positive Value : 98.96%)
False negatives
0.83 % (Predict Negative Value : 99.17%)
Precision
Evaluated
Accuracy
99.09 % (95% CI : 97.89 - 99.61, 545/550)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % (95% CI : 90.16 - 98.43, 96/100)
Clinical Specificity
99.78 % (95% CI : 98.75 - 99.96, 449/450)
Type of antigen
Nucleocapsid protein
Notes
Around 30 pathogens tested and confirmed no cross-reactivity, except SARS-CoV. lineages_performances 1. Positve standard material : 750 TCID50/mL 2. B.1.1.7 (Alpha) : 750 TCID50/mL 3. B.1.351 (Beta) : 750 TCID50/mL 4. B.1.617.2 (Delta) : 750 TCID50/mL 5.. P.1 (Gamma) : 750 TCID50/mL 6. B.1.1.529 (Omicron) : 750 TCID50/mL
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