3DMed 2019-nCoV RT-qPCR Detection Kit
Manufactured by 3D Medicines, China - www.3dmedcare.com/
Device identification number
4
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
N.A.
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
5 RNA-copies/test (5.00 RNA copies/test)
Positive control
positive control, process control, internal control ( MS2 RNA)
Negative control
yes
Analytical Specificity
tested negative with 27 species of microorganisms
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