Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR Method)
Manufactured by Suzhou TianLong Biotechnology Co. Ltd., China
Device identification number
2488
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Semi-automated
Physical Support
Microplate
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Deep (cough) sputum, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The test targets the ORF1ab region and the gene that encodes the N protein of the viral genome.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
32 minutes
Detection Principle
Fluorescence
LOD
200 copies/ml
Positive control
ORF1ab/N
Negative control
Buffer
Analytical Specificity
100 %
Clinical Sensitivity
98 %
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