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 (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
210 minutes
LOD
50 copies/reaction
Positive control
ORF1a and RdRp
Analysis of cross reactivity
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