GeneFinder™ COVID-19 Ag Plus Rapid Test
Manufactured by OSANG Healthcare Co. Ltd., South Korea - http://www.osanghc.com/en
Device identification number
2741
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, 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, 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
Information on antigen epitope targeted by the antibodies used in the design of the device
Target Epitope : 47-173 - Monoclonal ani-SARS-CoV-2 nucleoprotein antibody (detection Ab) Target Epitope : 44-175 -Monoclonal anti-SARS-CoV-2 nucleoprotein antibody (capture Ab)
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
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Published article 1 : https://www.mdpi.com/2075-4418/12/5/1126 - Title : Validation of GeneFinder COVID-19 Ag Plus Rapid Test and Its Potential Utility to Slowing Infection Waves: A Single-Center Laboratory Evaluation Study - Published article 2: - https://www.mdpi.com/2673-8112/2/3/16 - Title : BA.1 Omicron Variant of SARS-CoV-2: First Case Reported in Calabria Region, Italy * Clinical Performance 1. Direct Nasopharyngeal Swab (Prospective study) Total : 603 Samples (Positive : 151, Negative : 452) Sensitivity: 96.03% (95% CI 91.55 - 98.53) Specificity: 99.78% (95% CI: 98.77 - 99.96) 2. Direct Oropharyngeal Swab (Prospective study) Total : 544 Samples (Positive : 144, Negative : 400) Sensitivity: 90.28% (95% CI 84.34 - 94.12) Specificity: 100.00% (95% CI: 99.05 - 100.00) 3. Direct Nasal Swab (Prospective study) Total : 170 Samples (Positive : 70, Negative : 100) Sensitivity: 92.86% (95% CI 84.34 - 96.91) Specificity: 100.00% (95% CI: 96.30 - 100.00) 4. Stored swab samples in transport media (Retrospective study) Total : 500Samples (Positive : 100, Negative : 400) Sensitivity: 89.00% (95% CI 81.37 - 93.75) Specificity: 100.00% (95% CI: 99.05 - 100.00)
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 (RdRP/S gene : Ct value 27.67)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.68 % (Predict Postivie Value : 99.32% (95% CI : 96.25 - 99.88))
False negatives
1.1 % (Predict Negative Value : 98.69% (95% CI : 97.46 - 99.53))
Precision
Evaluated
Accuracy
99 % (95% CI : 97.85 - 99.54, 597/603)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.03 (95% CI : 91.55% - 98.53%, 146/151)
Clinical Specificity
99.78 (95% CI : 98.76% - 99.96%, 451/452)
Type of antigen
Nucleocapsid protein
Notes
1) Available to detect asymptomatic patients => 90% (63/70) sensitivity and 100% specificity (28/28) in brazil clinical study (Total 70 positive patients and 28 negative out of 98 asymptomatic participants); 2) Available to use stored freeze specimens in transport media (UTM/VTM) : Please refer to manual file. lineages_performances 1. Positve standard material : 750 TCID50/mL 2. B.1.1.7 (Alpha) : 750 TCID50/mL 3. B.1.351 (Beta) : 380 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. 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. Ohter variants detected: BA2 (Stealth)
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