Direct RT-qPCR SARS-CoV-2
Manufactured by Redcell Biyoteknoloji, Turkey - en.redcell.com.tr/
Device identification number
1714
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
80 minutes
LOD
500 cpm
Positive control
Synthetic SARS-CoV-2 genome fragment
Negative control
Synthetic SARS-CoV-2 genome fragmentDEPC-treated moleculer grade water
Analytical Sensitivity
97.63 %
Analytical Specificity
100 %
Clinical Sensitivity
96.92 %
Clinical Specificity
100 %
Throughput
96 samples/run
Notes
Test Kit for Detecting SARS-CoV-2 is a real-time reversetranscription polymerase chain reaction (rRT-PCR) test.The oligonucleotide primers and probes for specific detection of SARS-CoV-2 are selectedfrom regions of Open Reading Frame 1ab (ORF1ab) and the nucleocapsid gene (N) ofthe SARS-CoV-2 genome. https://en.redcell.com.tr/covid-19
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