ViroKey SARS-CoV-2 RT-PCR Test
Manufactured by Vela Diagnostics, Singapore - www.veladx.com/
Device identification number
751
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
210 minutes
LOD
50 copies/reaction
Positive control
ORF1a and RdRp
Crossreactivity
No cross-reactivity with 18 bacteria and virus species tested
Clinical Sensitivity
100 % ((95%CI: 88.6%-100%))
Clinical Specificity
100 % ((95%CI: 88.6%-100%))
Throughput
48 samples
Type of antigen
nucleoprotein
Notes
https://marketing.veladx.com/acton/media/31800/sars-cov-2-rt-pcr-test
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