SARS-CoV-2 Variant Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method)
Manufactured by Foregene Co. Ltd., China - www.foregene.com
Device identification number
2071
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Strip
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This kit uses Real-time RT PCR technology (rRT-PCR) for qualitative detection of SARS-CoV-2 and variant lineages nucleic acidsin human nasopharyngeal or oropharyngeal swab samples such as SARS-CoV-2 B.1.1.7 lineage (UK), B.1.351 lineage (ZA) , P.1 lineage (BR),B.1.617.1,B.1.617.2,B.1.617.3 lineage(India).
Assay Type
Nucleic acid-PCR
Reader Required
No
Subcategory
Validity test kit
Method
RT-PCR
Measurement
Qualitative
Time
55 minutes
Subclass
JRC-S
Detection Principle
Fluorescence
LOD
500 copies/ml
Positive control
plasmid with detection position and armed RNA
Negative control
TE buffer
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
96.72 %
Clinical Specificity
97.92 %
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