RefKit SARS-CoV-2 Multiplex qPCR Assay
Manufactured by REFGEN BİYOTEKNOLOJİ ANONİM ŞİRKETİ, Turkey - www.refgen.com
Device identification number
2926
CE Marking
✓Yes
HSC common list (RAT)
×No
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
RefKit SARS-CoV-2 Multiplex qPCR assay is developed by a probe-based one-step real-time RT-PCR technology for the molecular qualitative detection of SARS-CoV-2 RNA in collected samples from patients and provide results in less than one hour. The assay is specifically designed for testing from the upper respiratory tract (nasopharyngeal, oropharyngeal and nasal swabs, nasopharyngeal aspirate, bronchoalveolar lavage and saliva) samples collected in viral transport medium.
Assay Type
Nucleic acid-PCR
Self Test
No
Method
RT-PCR
Measurement
Quantitative
Time
56 minutes
LOD
0.4 cpu
Positive control
Synthetic SARS-CoV-2 genome partial RNA fragments and Synthetic Human RNAseP gene fragment
Negative control
Synthetic Human RNAseP gene fragment
Analytical Specificity
100 %
Clinical Sensitivity
96 %
Clinical Specificity
100 %
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