Novel Coronavirus (SARS-CoV-2) nucleic acid detection kit (Fluorescence PCR method)
Manufactured by Bioteke Taizhou Biotechnology Co. Ltd., China - www.bioteke.cn/
Device identification number
1486
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
50 minutes
LOD
500 copies/ml
Positive control
RNA pseudovirus containing target gene
Negative control
RNase free H2O
Analytical Sensitivity
95 %
Analytical Specificity
99 %
Clinical Sensitivity
95 %
Clinical Specificity
98 %
Throughput
48 samples/run
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