rTEST COVID-19/FLU qPCR DIAGNOSTIC KIT
Manufactured by MultiplexDX s.r.o., Slovakia - www.multiplexdx.coom
Device identification number
1332
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
81 minutes
LOD
3 cpr (range: 2-4)
Positive control
The PC4.01 consists of lyophilized isolated genomic RNA of SARS-CoV-2, IAV, IBV spiked with RNase P
Negative control
The NTC consists of using nuclease-free water (PCR water) in the RT-qPCR reactions instead of RNA
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples/run
Notes
https://www.multiplexdx.com/products/rtest-covid-19-flu-qpcr-diagnostic-kit
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