Freeze-dried Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit （Fluorescence PCR method）
Manufactured by BIOTEKE CORPORATION (WUXI) Co. Ltd., China - https://www.bioteke.cn/
Device identification number
2149
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Strip
Target type
Nucleic acid
Specimen
Anterior nasal swab, Nasal aspirate, Nasopharyngeal swab, Oropharyngeal swab, Sputum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
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
Subcategory
Validity test kit
Method
RT-PCR
Measurement
Quantitative
Time
60 minutes
Detection Principle
Fluorescence
LOD
500 cpm
Positive control
RNA pseudovirus containing target genes
Negative control
RNase free H2O
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