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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 & Influenza A/B Antigen Nasal Test Kit

Manufactured by Assure Tech. (Hangzhou) Co., Ltd., China - www.diareagent.com 

Device identification number
2280
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Other
Pathogens detected
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, Mycobacterium Tuberculosis, 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 A, Rhinovirus B
Commercial Status
Commercialised
Last Update
2021-06-23 01:48:26 CET
Comments
None
Assay Type
Immuno-Antigen
Time
15 minutes
LOD
251 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
None
Fn
A total of 27 SARS-CoV-2 positive samples were tested, 1 sample was negative by this RDT.
Precision
Evaluated
Accuracy
98.9 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.3 %
Clinical Specificity
100 %
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