Freeze-dried Novel Coronavirus (COVID-19) nucleic acid detection kit （Fluorescence PCR method）
Manufactured by Bioteke Taizhou Biotechnology Co. Ltd., China - www.bioteke.cn/
Device identification number
1856
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Microplate, Microtiter plate
Target type
Nucleic acid
Specimen
Nasal aspiration, Nasal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.bioteke.cn/
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Quantitative
Time
50 minutes
Detection Principle
Fluorescence
LOD
500 cpr
Positive control
RNA pseudovirus containing target gene
Negative control
RNase free water
Analytical Sensitivity
95 %
Analytical Specificity
99 %
Clinical Sensitivity
95 %
Clinical Specificity
98 %
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