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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



IVD CAPSULE COVID-19-SS

Manufactured by Abionic SA, Switzerland - www.abionic.com 

Device identification number
2993
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Biochip, Cartridge
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Saliva
Cross-reactivity (pathogens tested)
Adenovirus, 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), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, 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, SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The product is a very rapid SARS-CoV-2 antigen test giving results in under 2 minutes for saliva specimens (the collecting saliva swab is included). It is suitable for point-of-care environments.
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
Yes
Subcategory
Extraction kit
Method
Immunoassay
Measurement
Qualitative
Time
2 minutes
LOD
TCID50/ml 4x10E3 TCID50/mL
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % 0 out of 309
Fn
0 % 0 out of 12 for Ct<25
Fn
14.8 % (11 out of 74 for Ct<30)
Fn
30.8 % (33 out of 107 for Ct<35)
Fn
34.7 % (totally 40 out of 115)
Precision
Not evaluated
Accuracy
100 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % (for Ct<25)
Clinical Specificity
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