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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antigen Rapid Swab

Manufactured by ASSUT EUROPE SPA, Italy - www.assuteurope.com 

Device identification number
2248
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette, Strip
Target
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2021-06-23 01:55:10 CET
Comments
IVDD CE marked
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
50 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
2 AU
Fn
3 AU
Precision
Evaluated
Accuracy
99.3 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 %
Clinical Specificity
99.3 % (MAGLIANO DEI MARSI (AQ))
Type of antigen
Nucleoprotein

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