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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)

Manufactured by Beijing Hotgen Biotech Co., Ltd, China - www.hotgen.com.cn/ 

Device identification number
1870
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Lateral flow, Strip
Target
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2021-05-10 08:07:30 CET
Comments
This kit is used for in vitro qualitative determination of novel coronavirus antigen in human nasal swabs or throat swabs. It is used as rapid investigation for suspected cases of novel coronavirus, can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contained novel coronavirus antigen. A negative test result does not rule out the possibility of infection. This product is only used for clinical and emergency reserve during the pneumonia outbreak of novel coronavirus infection, and can not be used as a routine in vitro diagnostic reagent for clinical application . The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests. For professional use only.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
250 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
0 %
Precision
Evaluated
Accuracy
98.87 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
97.1 %
Clinical Specificity
99.76 %
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