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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



AFIAS COVID-19 Ag

Manufactured by Boditech Med Inc, South Korea - https://www.boditech.co.kr/en 

Device identification number
1989
CE Marking
Yes
HSC common list (RAT)
Yes
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, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H3N2, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, SARS-CoV
Lineages detected
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), P.1 (Gamma), P.2 (Zeta), P.3 (Theta), B.1.1.529 (Omicron), C.37 (Lambda),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
In the Link of Status validatie SARS-CoV-2 antigeen sneltesten, you can verify the clinical study, which shows that AFIAS COVID-19 Ag has a sensitivity of Ct <30: 96,4%.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
12 minutes
Subclass
Membrane-based
LOD
35.15 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1.25 % (2 false positive out of 160 tested negative samples confirmed by RT-PCR)
Fn
8.1 % (11 false negative out of 135 tested positive samples confirmed by RT-PCR)
Precision
Evaluated
Accuracy
95.6 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
91.9 % (95%CI: 86.0% ~ 95.4%)
Clinical Specificity
98.8 % (95%CI: 95.6% - 99.7%)
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