SARS-CoV-2 Nucleic Acid Detection Kit(Multiplex PCR Fluorescent Probe Method)
Manufactured by Foregene Co. Ltd., China - www.foregene.com
Device identification number
1869
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Strip
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Quick and easy; Avoid nucleic acid loss; Low detection limit and high sensitivity; Low equipment requirement and highly flexible use
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Measurement
Qualitative
Time
55 minutes
Detection Principle
Fluorescence
LOD
500 copies/ml
Analytical Sensitivity
96.72 %
Analytical Specificity
97.92 %
Clinical Sensitivity
96 %
Clinical Specificity
97 %
Notes
Target: S gene
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