Certest Biotec VIASURE V-Flex

Diagnostic laboratories worldwide employ PCR-based tests to identify a range of illnesses, from respiratory and gastrointestinal infections to tropical diseases. However, sample preparation is often performed manually, which is time consuming and prone to errors, limiting the number of tests that can be performed each day. Many labs have turned to automation to increase throughput, but this isn’t always practical for those running low numbers of samples for each pathogen. In response to this challenge, Certest Biotec – a Spanish biotechnology company – partnered with Tecan to develop an automated and flexible workstation capable of performing nucleic acid extraction and PCR set-up for multiple different PCR reactions in a single plate.

Certest develops and manufactures a variety of in vitro diagnostic products for the detection of viruses, bacteria and parasites, including real-time (RT)-PCR kits under the VIASURE brand. During the SARS-CoV-2 pandemic, the company identified a need for flexible automation workstations that could run its kits at higher throughput. Dr Cristina Escolar, Product Specialist Manager for Molecular Diagnostics, explained: “The pandemic placed extraordinary pressure on diagnostic laboratories, which required a solution to cope with heightened workflow volumes. We envisioned an easy-to-use system to automate VIASURE reagents, as well as allow the processing of different clinical samples for subsequent analysis by RT-PCR.”

Certest’s roots are steeped in biotechnology, but this vision required engineering expertise on a grand scale, far beyond what the company could achieve alone. Cristina continued: “We’ve never worked in the field of engineering before, but we had clear ideas of what we wanted to create: a solution that could process a large volume of samples and simultaneously minimize the workload of the technicians in a laboratory. However, when we began to put these initial theories into practice, itbecame obvious that there were many things that we hadn’t considered, which is when we started looking externally for help.”

“We have a long history with Tecan, routinely using the company’s liquid handling workstations during the manufacture of our RT-PCR kits. This naturally led us to approach Tecan to help in the development of our own system, entering a partnership and basing our platform on the Cavro® Magni Flex. We started by creating a basic worktable and incorporating modules our users would need, knowing that they mostly work with clinical samples in a 96-well format, as well as using different types of tubes and labware. The system has eight channels that can move independently – allowing the desired level of flexibility and throughput – and we incorporated a gripper arm so users can move plates around the worktable. The rest of the worktable has been configured according to the different steps of the extraction process; we added a ThermoShaker for heating and agitating samples, and another position for sample separation using magnetic beads. There is also a cooler unit to store the final nucleic acid for up to eight hours, in case the technicians are not in the lab when the process finishes. There is even a station for tips of different sizes – given the broad pipetting range we need to use for the different reagents – so that everything is contained within the worktable, which is very important to maintain a sterile environment and when working with potentially infectious clinical samples.”

The result of this huge undertaking is the VIASURE V-Flex, a fully automated platform for nucleic acid extraction, purification and PCR set-up. The Cavro Magni Flex provides all the technological benefits Tecan is known for – such as handling small volumes and pipetting precision – but its advantages extend beyond this. Cristina commented: “We’ve built an instrument with the flexibility to process various sample types without having fixed numbers, even allowing the running of different diagnostic kits on the same processing plate. For example, if 10 sputum samples that need testing for a respiratory virus arrive at the same time as 10 fecal samples that need testing for gastrointestinal infection, they can all be run at the same time, reducing the waiting times for results. The instrument also incorporates the Tecan MAPlinx™ Software, which makes the platform easy to set up maintain, and provides a simple, automated and clear process to qualify the instrument after it has been installed. In addition, MAPlinx gives field service engineers the ability to troubleshoot any hardware issues, as well as managing instrument integrity after a service, complementing the carefully thought out design of the V-Flex.”

“The design and development of the V-Flex platform has been a bit like trying to build an airplane while it's flying but, thanks to the partnership between Tecan and our team here at Certest, we have created an instrument suited to the needs of diagnostic laboratories regardless of their workload. The development of a second version is already underway, which will offer even more adaptability. We are also searching for ways to reduce the wastage of reagents for laboratories that do not need to run full 96-well plates at a time, solving a big problem for smaller departments. We look forward to continuing our collaboration with Tecan for future iterations, as well as searching for methods to improve the service we provide to our customers.” Cristina concluded.

To find out more about Synergence OEM system development services, visit www.tecan.com/synergence

For more information about the VIASURE V-Flex from Certest, visit www.certest.es