Improved clinical pathogen testing using innovative methods will benefit patients

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JRC scientists, in collaboration with partners of a European research project, addressed measurement issues that impact on the monitoring of harmful microorganisms. They conclude that innovative and standardised methods have the potential for better measurement results in supporting clinicians and patients’ health status.

Clinical laboratories increasingly use nucleic acid-based tests that are replacing traditional microbiological culturing methods, amongst others due to higher speed and information content for detection of infectious diseases. However, the current situation in clinical pathogen testing needs measurement improvements. There are challenges in the field of detection of the human cytomegalovirus, BK virus and Epstein-Barr virus. Moreover, the detection of the Mycobacterium tuberculosis and influenza virus would benefit from a better understanding and less arbitrary assessment of the performance of qualitative methods.

As a result, scientists from the JRC-Institute for Reference Materials and Measurements (IRMM) and partners of the European INFECT-MET project (funded by the EMRP participating countries within EURAMET and the European Union) have jointly elaborated the need for standardisation of nucleic acid tests for clinical measurements of bacteria and viruses. Emphasis was laid on three model pathogens selected by INFECT-MET, namely Mycobacterium tuberculosis, the cytomegalovirus (CMV), also called human herpesvirus, as well as influenza virus.  Concepts for achieving improved reliability and accuracy of measurements are being presented. The paper also includes improved advanced concepts for determining the diagnostic sensitivity of qualitative tests, i.e. those tests which are designed to detect the presence or absence of a pathogen but not the microbial load. Innovative quantitative nucleic measurement methods, such as those based on dPCR (Digital Polymerase Chain Reaction technique) have the potential to achieve this goal if adequately designed and validated.

Read more in: J. Pavšic et al., “Standardisation of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses“, J Clin Microbiol 53 (2015) 2008 –2014, doi:10.1128/JCM.02136-14.