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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV RT-qPCR

Manufactured by 3D Medicines, China - www.3dmedcare.com/ 

Device identification number
2
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
Performance of 3D 2019-nCoV RT-qPCR Detection Kit has only been established in the specimens collected with oropharyngeal swabs and nasopharyngeal swabs.
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
LOD
5 RNA-copies/test
Positive control
ORF1ab, N and E gene. Internal control
Negative control
Not found
Analitical Specificity
tested negative with 27 species of Viruses/Bacteria/Parasites
Clinical Sensitivity
96 % (PPA 96-100% compared to NGS assays and CDC method)
Clinical Specificity
100 % (NPA 100%-100% compared to NGS and CDC method)
Throughput
Single tubes
Notes
http://www.3dmedcare.com/UploadImage/covid/01%20IFU%20for%203DMed%202019-nCoV%20RT-qPCR%20Detection%20Kit.pdf

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