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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

BIOSYNEX AUTOTEST ANTIGENIQUE COVID-19 Ag

Manufactured by BIOSYNEX S.A., Switzerland - www.biosynex.com 

Device identification number
2965
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Specimen
Nasal 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, Enterovirus A71 (EV-A71), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, Mumps Virus (MuV), 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
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.351 (Beta), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N/A
Assay Type
Immuno-Antigen
Self Test
No
Method
Immunochromatography
Time
15 minutes
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 0 false positive out of 140 tested negative samples confirmed by RT-PCR
False negatives
2.75 % (3 false negative out of 109 tested positive samples confirmed by RT-PCR)
Precision
Evaluated
Accuracy
98.4 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.2 % (Antigen)
Clinical Specificity
100 % (Antigen)
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