COVID-19
Lessons learned from setting and scaling up a SARS-CoV-2 RT-qPCR testing platform
Biogazelle, a Belgian contract research organisation, offers high-value applications to support research, clinical trials, and diagnostic test development for the pharma and biotech industry. As an ISO17025 accredited lab for RT-qPCR services, Biogazelle had the unique skill set and expertise to develop a robust, sensitive and high-throughput test for SARS-CoV-2 in record time. Professor Jo Vandesompele, its co- founder and chief scientific officer, explains how the company did it.
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n the absence of an effective therapeutic or vaccine, the global strategy to prevent the spread of Covid-19 has been a combination of quarantining, social distancing and widespread PCR testing for the presence of viral RNA. In designing its testing platform, Biogazelle did not want to be reliant on off-the-shelf magnetic bead-based viral RNA purification and CE-IVD-approved multiplex RT-qPCR assays. It placed special emphasis on the choice of reagents, consumables and instruments – in order to minimise potential supply chain issues stemming from increased global demand – with the following guiding principles:
Flexible and modular: different components from different suppliers can work together, each optimised for their specific part of the workflow.
High-throughput and smart scalable: the platform should handle at least 6,000 samples per day. Further increase in capacity could come through an introduction of more units of a given module, or more instruments in a module.
Business continuity assurance: establishment of strategic stocks, standing orders, drop shipments and validation of alternative suppliers. For instance, for the RT-qPCR mix and the RNA extraction, we have two validated suppliers to mitigate supply chain issues.
Autonomous platform: no A to Z commercial solution, most of which are relatively slow and/or generally face worldwide shortages for instruments and consumables.
92 | Outsourcing in Clinical Trials Handbook
High quality: obviously, it’s a diagnostic test, but built for constant innovation and improvements through internal cross-validation.
Biogazelle’s SARS-CoV-2 RT-qPCR test involves the transfer of the primary sample tube to a 96-well plate to increase throughput downstream, followed by viral RNA purification, RT-qPCR detection of the virus, data-analysis and authorisation. A lot of the innovative solutions the company came up with had the double goal of increasing efficiency, while also minimising the biosafety risk posed to operators. For example, while virtually all commercial nasopharyngeal swab solutions are designed to keep the virus alive in the individual patient tube, it realised that this was not necessary. In fact, collecting the swab in a virus inactivating and RNA preserving solution not only makes it safe to work with the transfer fluid, but it also stabilises the RNA – resulting in higher detection sensitivity, tested for up to five days. To select a suitable RNA extraction kit,
Biogazelle evaluated the cost, ease-of-use, throughput, guaranteed availability and, of course, performance. The company went to great lengths in comparing five different RNA extraction methods in a standardised set of viral stock dilutions, and positive and negative patients samples. Patient samples and viral stock were collected in four different transport media that are routinely used, including liquid Amies (eSwab buffer) and PBS. The results were quite shocking, with different
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