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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-NP

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

Device identification number
2975
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Biochip, Cartridge
Target type
Antigen
Antibody type
Monoclonal
Specimen
Nasopharyngeal swab, 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
2022-06-22 02:34:00 CET
Comments
IVD CAPSULE COVID-19-NP is a very rapid SARS-CoV-2 antigen test giving results in under 2 minutes for nasopharyngeal specimens (the collection NP swab is included). It is suitable for point-of-care environments. Optionally (with another accessory saliva swab), it can also be used with saliva specimen with specifically tested performance as given in the IFU. The diagnostic performance was validated in an independent external study executed by Unilabs (Switzerland).
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Subcategory
Extraction kit
Method
Immunoassay
Measurement
Qualitative
Time
2 minutes
LOD
755 TCID50/ml (Nasopharyngeal)
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
% Nasopharyngeal: 2 out of 301
Fn
0 % Nasopharyngeal: 0 out of 24 (for Ct<25)
Fn
8.4 % (7 out of 83 for Ct<30)
Fn
16.6 % (18 out of 108 for Ct<40)
Precision
Not evaluated
Accuracy
100 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % (for Ct<25 - Nasopharyngeal)
Clinical Sensitivity
83.3 % (overall - Nasopharyngeal)
Clinical Specificity
99.3 % (Nasopharyngeal)
Type of antigen
Nucleocapsid protein
Notes
Microfluidic

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