SARS-CoV-2 Nucleic Acid Detection Kit(Multiplex PCR Fluorescent Probe Method)
Manufactured by Foregene Co., Ltd - www.foregene.com
Device identification number
1869
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Manual
Physical Support
Strip
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
03/15/2021 05:16
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
Subcategory
Other
Method
RT-PCR
Measurement
Qualitative
Time
55 minutes
LOD
500 copies/ml
Analytical Sensitivity
96.72 %
Analitical Specificity
97.92 %
Clinical Sensitivity
96 %
Clinical Specificity
97 %
Notes
Fluorescence detection
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