AFIAS COVID-19/Flu Ag Combo
Manufactured by Boditech Med Inc., South Korea - https://www.boditech.co.kr/en
Device identification number
1449
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cartridge, Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Herpes Simplex (HSV), Influenza A, Influenza B, Mumps Virus (MuV), Mycobacterium Tuberculosis, Respiratory Syncytial V (RSV) Type A, Rhinovirus
Pathogens detected
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The sens/spec of this kit can be compared with AFIAS COVID-19 Ag product (Device Identification number : 1989). https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/1989
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Membrane-based
LOD
35.15 TCID50/ml (SARS-CoV-2)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 0 false positive out of 117 tested negative samples confirmed by RT-PCR
False negatives
3.2 % (1 false negative out of 31 tested negative samples confirmed by RT-PCR)
Precision
Evaluated
Accuracy
99.3 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.8 % (95%CI:81.5% - 99.8%)
Clinical Specificity
100 % (95%CI: 96.0% - 100%)
Type of antigen
Nucleocapsid 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