STMicroelectronics has developed the Q3-Plus platform in order to collect gene expression molecular data on the prospective patients enrolled for the OraMod project. Q3-Plus is an innovative compact system that performs analysis of DNA and RNA on Lab-on-Chip cartridges, by means of real-time Polymerase Chain Reaction (PCR). It can represent a new frontier in portable molecular diagnostics.

The Q3-Plus system can be used by unskilled personnel working directly “on the field” as a Point-of-Care system – as instance, directly in the Otorhinolaryngology hospital department, in OraMod scenario – yielding fast and reliable results at competitive prices. Compared with standard laboratory instrumentation, the lower price of Q3-Plus platform eliminates the need to perform a batch of tests in order to be cost effective.

It is composed of three main components: a single-use Lab-on-Chip cartridge, a portable instrument and a dedicated software.

The Lab-on-Chip cartridge is the disposable component where the reactions occur; it is based on a silicon microchip that allows very precise and fast thermal control, which is needed for efficient real-time PCR with short time-to-results.

The instrument is very compact and lightweight, making it easily portable to the point of need; it integrates a lot of ST’s technology, especially for thermal control of the cartridge and measurement of the fluorescence signals inside the reaction mixture.

The software has been developed and fully customized for the OraMod purpose. Ease-of-use has been the key objective for its development. In fact, this software is totally “closed”; that is, all the reaction parameters are pre-determined and not modifiable, almost eliminating the possibility to make a mistake. The operator is guided through the very simple procedure by instructions on screen. Moreover, at the end of the test a dedicated data analysis automatically interprets the raw data and shows the results in a simple way. Another fundamental feature is that the software constantly interacts with the OraMod server developed by OneToNet: from login of the operator, through selection of the patient to analyze among an always-updated list, to automatic upload of the data generated by Q3-Plus to the OraMod server.

After developing all the components of Q3-Plus platform, ST has optimized them and demonstrated that the qRT-PCR performances are more than enough for the purpose. qRT-PCR stands for “quantitative Reverse Transcription-PCR”, that is, quantification of target mRNAs – which is the aim of OraMod molecular study.

ST has then administered a training on Q3-Plus use to the clinical partners – UNIPR, VUmc, UDUS – and has given them Q3-Plus instruments, Lab-on-Chip cartridges and the first version of the software. Feedbacks on usability are constantly collected from the partners, in order to release soon the final version of the OraMod dedicated software.

The clinical partners are now starting to use the Q3-Plus system: first on some retrospective samples, in order to compare the obtained data with those generated by standard instruments on the same samples. Then, they will analyze all the newly enrolled, prospective patients; their molecular data will be automatically uploaded to the OraMod server, where they will feed the prognostic models developed by VUmc.

The single-use Lab-on-Chip cartridge

The portable Q3-Plus instrument. It measures only 14 x 7 x 8.5 cm and weighs 300 g.

The OraMod dedicated software. This is the final screen with the results that are automatically uploaded to the OraMod server.