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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)
Yes
Format
Near POC / POC, Semi-automated
Physical Support
Biochip, Cartridge
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
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
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2023-02-17 08:44:03 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.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Subcategory
Extraction kit
Method
Immunoassay
Measurement
Qualitative
Time
2 minutes
Subclass
Other (Nanofluidic)
Detection Principle
Immunofluorescence
LOD
755 TCID50/ml (Nasopharyngeal)
Calibration
Not evaluated
Analytical Sensitivity
100 % (For samples with a viral load at the indicated LOD (or higher))
Analytical Specificity
100 % (Based on tested interference substances)
Analysis of cross reactivity
Evaluated
False positives
samples 0 out of 326 negative samples
False negatives
31 samples (31 out of 105 positive samples)
Precision
Not evaluated
Accuracy
100 %
Robustness
Evaluated
Clinical Sensitivity
93 % (Nasopharyngeal: for Ct≤30)
Clinical Specificity
100 % (Nasopharyngeal: for 326 negative samples)

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