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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Detection Kit

Manufactured by New Gene (Hangzhou) Bioengineering Co., Ltd, China - www.new-gene.net/ 

Device identification number
1501
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
Adenovirus, Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Commercial Status
Commercialised
Last Update
2021-11-03 09:36:34 CET
Comments
The COVID-19 Antigen Detection Kit by New Gene (Hangzhou) Bioengineering Co., Ltd. has been widely used in practice in many EU member countries. Please visit the following links, and search search “New Gene” in their whitelists for more information. (Germany) https://antigentest.bfarm.de/ords/f?p=110:100:17097377707548 (France) https://covid-19.sante.gouv.fr/tests (Belgium)https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/covid_19/tests ( Italy) https://www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=ACTION_MASCHERA (Portugal) https://www.infarmed.pt/web/Infarmed/pesquisa-dispositivos
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Sample collection device
Method
Immunoassay
Measurement
Qualitative
Time
30 minutes
Subclass
Sandwich, Double
LOD
0.05 ng/mL
Calibration
Evaluated
Calibration
Evaluated
Crossreactivity
Evaluated
Crossreactivity
Evaluated
Fp
0.87 % (1 out of 114)
Fn
2.02 % (5 out of 247)
Precision
Evaluated
Accuracy
98.3 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 % (Antigen)
Clinical Specificity
99.1 % (Antigen)
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