An easy path to automated molecular diagnostics
Automation plays an important role in molecular diagnostic workflows, minimizing manual interventions to help increase throughput and protect laboratory staff from potentially harmful pathogens. Finnish biotech enterprise Mobidiag specializes in developing and marketing novel, innovative molecular diagnostic solutions for infectious disease testing, and worked with Tecan to develop the Amplidiag® Easy platform for walkaway nucleic acid extraction and PCR plate set-up. This system is now helping with the detection of SARS-CoV-2, thanks to the newly launched Amplidiag COVID-19 molecular test.
Effective handling for dangerous pathogens
The Amplidiag Easy platform – introduced in 2017 – was originally designed for high volume screening and antibiotic resistance testing for gastrointestinal pathogens. Juha Kirveskari, R&D Director for Assay Development at Mobidiag, explained: “User safety is paramount in clinical laboratories, and molecular diagnostics can minimize the risk associated with the analysis of dangerous pathogens. However, performing these workflows manually is laborious and time consuming.”
Mobidiag worked with Tecan Synergence™ to develop the Amplidiag Easy system to automate nucleic acid extraction and PCR plate set-up for its panel of Amplidiag multiplex stool diagnostic tests.
“We already had a semi-automated platform, and wanted to fully automate our suite of real-time PCR-based assays for gastrointestinal diseases. We discussed our ideas with Tecan, the company suggested some very helpful features, and the result was Amplidiag Easy,” Juha added.
Adaptable to the current crisis
As a CE-marked instrument, the configuration and coding of the Amplidiag Easy system are locked, but there's still quite a lot of flexibility. Mobidiag has taken advantage of this versatility to create a new compatible assay – the Amplidiag COVID-19 test – to help meet the exceptional demand for molecular diagnostics in the current COVID-19 crisis. Dorothée Allard, MarCom Manager, explained: “Since the scale of the current pandemic became clear, our R&D team has worked tirelessly to develop molecular tests for the SARS-CoV-2 virus. Our primary focus as a company has historically been on detection and antibiotic resistance testing for gastrointestinal diseases, working with stool or biopsy samples. We therefore adapted the workflow to work with the nasopharyngeal swabs used for detecting respiratory diseases such as COVID-19.”
The Amplidiag Easy is a versatile, fully integrated platform operated through a simple TouchTools™-based graphical user interface. It includes a Te-MagS™ module for Mobidiag’s magnetic-bead based assays, a heat block, and a PosID™ barcode reader, which saves a lot of user time by automatically scanning all the sample tubes. The system can also accommodate all the consumables needed for the assays – reagent tubes, extraction beads and PCR plates.
This set-up enables users to perform parallel extraction for 48 samples in just two hours, producing two ready-to-run qPCR plates. Juha commented: “It is just not practical to do this manually, as it is quite a complex assay set-up. In theory, it would take a full day to perform, but it would be almost impossible to maintain the high level of concentration required to handle large numbers of samples without making a mistake, increasing the risk of cross-contamination and erroneous patient results. With the Amplidiag Easy, manual interventions are virtually eliminated.”
Supporting the fight against COVID-19
The Amplidiag COVID-19 test was initially approved for emergency use in several countries across Europe, and received CE marking at the beginning of June 2020. Mobidiag is working closely with Tecan to supply additional Amplidiag Easy systems to multiple sites in Finland, Sweden, France and the UK. Sara Mattei, Marketing Manager, added: “We are relying on Tecan’s global reach and resources to help us meet demand for extra automated systems, particularly for the main Finnish clinical laboratories sites – HUSLAB, SYNLAB and Mehiläinen.”
To find out more about Tecan Synergence™ OEM automated solution development services, visit www.tecan.com/synergence
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