STANDARD F COVID/Flu Ag Combo FIA
Manufactured by SD BIOSENSOR Inc., South Korea - http://sdbiosensor.com/xe/
Device identification number
24757
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, 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 A H1N1, Influenza A H3N2, 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 B, SARS-CoV
Pathogens detected
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, SARS-CoV
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2023-03-27 05:00:02 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Fluorescence
LOD
216 TCID50/ml
Calibration
Evaluated
Analytical Sensitivity
90.91 % (According to the results of clinical evaluation study)
Analytical Specificity
100 % (According to the results of clinical evaluation study)
Analysis of cross reactivity
Evaluated
False positives
samples 0/195
False negatives
5 samples (5/55)
Precision
Evaluated
Accuracy
100 % (According to the results of the precision study)
Robustness
Evaluated
Clinical Sensitivity
90.91 % (50/55 (95%CI: 80.05% - 96.98%))
Clinical Specificity
100 % (195/195 (95%CI: 98.13% - 100%))
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