Bio-Speedy Direct RT-qPCR SARS-CoV-2
Manufactured by Bioeksen R&D Technologies Ltd., Turkey - www.bioeksen.com.tr
Device identification number
1060
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
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
65 minutes
LOD
89 cpm (range: 89 - 562 cpm)
Positive control
Synthetic SARS-CoV-2 genom fragment and nucleic acid extract from human for RNase P
Negative control
Water, DEPC-Treated, Molecular Biology Grade (CAS 7732-18-5)
Analytical Sensitivity
99.8 %
Analytical Specificity
100 %
Clinical Sensitivity
97.8 %
Clinical Specificity
100 %
Throughput
96 samples/run
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