IFU_EN_GEN-HT Version 1.01
July2020
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Background Information
OptiGene Limited was formed in 2008 to develop and deliver advanced molecular diagnostics
solutions for applications across a range of market sectors, with the primary goal of providing
the highest quality instrumentation and performance-leading reagents to support isothermal
amplification of DNA and RNA. The market pull for this venture came from the growing
demands around the world for field testing, rapid results and point-of-care diagnostics.
OptiGene has developed innovative products that support sensitive and specific detection of
bacteria and viruses, for use in the fields of plant health, food safety, veterinary medicine,
environmental monitoring and human healthcare. Bio-defence and forensics are also key
markets that OptiGene addresses, either directly or through its growing network of
international distributors. The company has exploited its expertise in both instrument design
and enzymology to develop a sophisticated open platform that will support all isothermal
amplification methods that employ target detection by fluorescence measurement. Ultra-
sensitive molecular detection that has previously been constrained to laboratory use by highly-
qualified personnel and taking hours to complete can now be deployed to point of application
and run with very little training, producing results in single minutes. A continuous programme
of development is maintained at OptiGene to satisfy the evolving demands of its customers
and the wider market, in both instrumentation and enzymes and assays.
The Genie® platform
OptiGene Genie® instruments are essentially highly sophisticated temperature-controlled
fluorimeters. They are almost exclusively applied to running molecular diagnostic assays employing
isothermal amplification of DNA and RNA, enabling sensitive detection of bacteria and viruses at
a molecular level by fluorescence measurement. Genie® HT is the flagship high-throughput
instrument; it was released to market in spring 2020, joining Genie® II (released 2011) and
Genie® III instruments, many of which are to be found in a variety of diagnostic settings around
the world. This powerful and extremely flexible platform allows isothermal amplification of
DNA and RNA to take place in a compact device.
All Genie® instruments operate with the OptiGene strip-of-8 reaction tubes (catalogue number
Genie® strips OP-0008-50 [50 strips] and OP-0008-500 [500 strips]). This proprietary consumable
incorporates attached, locking caps which allow for a closed tube assay to prevent cross-
contamination. Enzymes are available in the form of several master mixes that feature combinations
of high-speed operation, inherent RT activity and thermostability, together with separate primers,
specific to the target bacterial or virus RNA/DNA.
Specific instructions for the preparation and use of the Genie® strips are to be found in the
appropriate OptiGene assay Instructions for Use (e.g. COVID-19_RNA RT-LAMP KIT-500_IFU V1.0
10/07/2020 and COVID-19_Direct RT-LAMP KIT-500_IFU V1.0 10/07/2020 for SARS-CoV-2 RNA).
To perform a test, the instrument is switched on and the software allowed to initialise. Dry and
disinfected loaded strips are placed in the instrument’s heater block (Genie® III – single block;
