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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Novel Coronavirus (COVID-19) Antigen Detection Kit (Swab)

Manufactured by Zhejiang Gene Science Co., Ltd, China - http://www.gene-science.com/ 

Device identification number
2684
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Card, Lateral flow, Strip
Target type
Antigen
Targets
nucleocapsid protein,
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), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-12-08 06:32:51 CET
Comments
None
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Time
15 minutes
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1.27 %
Fn
5.42 %
Precision
Evaluated
Accuracy
96.81 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.58 %
Clinical Specificity
98.73 %
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