PCR Diagnostics products

DIANA Biotechnologies has developed series of ultra-sensitive PCR-based diagnostics to fight the COVID-19 epidemic. These are optimized to be run in diagnostic labs in high-throughput format. Our COVID-19 tests are currently in use at over 30 clinical laboratories in the Czech Republic and also being exported abroad. We have already produced more than 6 milion COVID-19 tests, covering 40 % of Czech testing capacity.

In January 2021 we have introduced to the market our novel technology DBdirect, allowing PCR detection directly from clinical samples (both nasopharyngeal swabs and saliva) without the need of prior isolation of RNA. DBdirect based saliva tests can in our view revolutionize the COVID-19 testing, combining ultra-sensitive detection with the easy self-collection of the samples. These tests are suitable both for clinical diagnostics (CE IVD mark) and preventive screening programs.

  • Parallel detection of SARS-CoV-2, Influenza A, Influenza B, RSV
  • Manual and automated sample processing
  • Ultra-sensitive analysis(LOD 2 to 10 copies depending on virus type)
  • Design taking into consideration most recent virus sequences
  • Tested for nasopharyngeal swabs and saliva
  • Standard RT-PCR version and DBdirect™ version (without the need for RNA isolation)
  • More than 6 million tests performed
  • Czech development and production
  • Ultra-sensitive analysis (LOD 1 virus copy)
  • 4 kit versions – enables optimal choice for every lab
    • 2 detection methods: standard RT-PCR a DBdirect™ (direct RT-PCR without RNA isolation)
    • 2 multiplex designs: they differ in the detected genes and in the possibility to differentiate virus variants
  • Validated for diagnosis from nasopharyngeal swabs and saliva
  • Suitable for manual and automated sample processing
  • High efficacy of RNA isolation
  • Reproducible and applicable to a range of biological samples, such as pharyngeal and nasal swabs or saliva
  • Efficacy of COVID-19 RNA isolation is tested for each lot
  • In-house production from basic chemicals, sustainable large scale production 
  • Two versions of the kit currently available:
    • Automated RNA isolation kit for Agilent Bravo (DB-1206, reagents provided in multi-well plate format, includes all the plastic required)
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  • Easy self-collection of upto 1.2 ml of saliva sample
  • CE-IVD marked – validated for in vitro diagnostics from saliva
  • Compatible with 96 well-plate racks / automation
  • 2D barcoded – unique ID on each tube
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