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New Diagnostics for Infectious Diseases: “ND4ID”

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The next generation of in vitro diagnostics

There is a great unmet medical need for point-of-care assays to diagnose infectious diseases. A large European initiative addressed the gaps in in vitro diagnostics by training the next generation of researchers.

Health

As highlighted by the COVID-19 pandemic, diagnostics is a major limiting factor in the identification and treatment of microorganisms causing infections. This renders infectious diseases a major burden on public health and the global economy.

A training network for in vitro diagnostics (IVD) development

To address this problem, the ND4ID project offered a holistic training programme to prepare the next generation of researchers in the field of IVD. Undertaken with the support of the Marie Skłodowska-Curie Actions programme, ND4ID aimed to bridge the gap between technological innovation and clinical need. ND4ID trained 15 early-stage researchers (ESRs) across the full breadth of disciplines spanning clinical, technological and market-oriented viewpoints. ESRs were selected from a wide range of scientific backgrounds such as clinical, biotechnology and electrical engineering. Each ESR worked on a particular aspect of the diagnostics landscape, covering respiratory tract and urinary tract infections as well as antimicrobial resistance. The training commenced with identification of clinical needs and shortcomings in current IVD. The participation of pharmaceutical companies in the project further offered young researchers the opportunity to familiarise themselves with the IVD development pipeline, including legal, financial and regulatory issues. “Alongside technological advances, the training of the students was the most important achievement of ND4ID,” notes project coordinator Herman Goossens.

Advances in IVD development

A point-of-care (POC) assay usually detects DNA, proteins or other molecules of the target microorganism. Given the low levels of these molecules present in patient samples, sensitivity is a key parameter in POC performance. “In any case, even with the best combination of technologies, an IVD must relate to the clinical need,” says Goossens. Therefore, ND4ID activities included novel biomarker investigation and bioassay development as well as new diagnostics tools. ESRs worked on projects that exploited the power of genome sequencing in diagnostics. They developed genotype tests for antimicrobial susceptibility and the identification of key virulence determinants of urinary tract infections. Additional state-of-the-art bioassays were generated with high sensitivity and specificity for subsequent use in digital diagnostics. Switching from paper to plastic offered increased immunoassay sensitivity and better sample flow properties. Furthermore, emphasis was given to the high-throughput selection of antibodies to be used in IVD. ND4ID addressed sepsis detection, which is currently limited by the low number of bacteria in blood. Through a method that concentrates blood bacteria, partners are hopeful to achieve increased sensitivity and significantly move the field forward.

Prospects of ND4ID deliverables

To address the high cost of IVD, which limits their implementation in clinical practice, scientists developed a low-cost molecular device based on DVD technology. One student developed a simple digital dipstick that allows the rapid identification of microorganisms causing urinary tract infections. Many of the ND4ID solutions, such as the next-generation sequencing test for antimicrobial susceptibility, will be directly exploited by the project’s industrial partners. The antibody-screening platform will be promoted by a spin-off company from KU Leuven to provide antibodies to academic and industrial partners. Overall, ND4ID has generated IVD innovations and paved the way for future research in the field. The developments further strengthen Europe’s position in the internationally competitive arena of IVD technology.

Keywords

ND4ID, IVD, training, urinary tract infection, in vitro diagnostics, bioassay, point-of-care, blood bacteria

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