Respiratory tract infections such as pneumonia, influenza and tuberculosis account for almost 50 % of all deaths from infections. Accurate and rapid disease diagnosis is important for public health protection, monitoring transmission in the community and checking for increasing antibiotic resistance. The infectious disease testing market is growing rapidly, with the in-vitro diagnostics predicted to be worth $75.1 billion by 2020. Molecular diagnostic technologies will be a major driving force behind this growth, but there are issues concerning quality, comparability and traceability of measurements.
Bacteria and viruses present in clinical samples at very low levels make accurate disease detection and measurement challenging. A lack of measurement consistency can lead to over- or under-diagnosis, resulting in costly and inappropriate treatment. The EMRP project HLT08 Metrology for monitoring infectious diseases, antimicrobial resistance, and harmful micro-organisms successfully developed highly accurate SI traceable methods to support the quantification of bacteria in clinical samples and generated reference materials for use in External Quality Assessment schemes.
- Developed quantitative, validated methods for the measurement of viruses and bacteria with known uncertainties for digital polymerase chain reaction (PCR) methods used for extracting and rapidly amplifying DNA.
- Developed a reference material and measurement framework using traceable digital PCR approaches in collaboration with end-user communities. The calibration and quality assurance of current clinical PCR for diagnostic kits and ‘in-house’ clinical tests for detecting bacterial diseases was improved.
- Evaluated new and emerging molecular approaches (next generation sequencing and epidemiology) for the surveillance and monitoring of bacterial infectious disease load and detection of antimicrobial resistant mutations.
- Evaluated new and emerging diagnostic technologies for the rapid detection of infectious agents including the measurement challenges associated with rapid, near-patient testing.
The project team worked with the standards, quality assurance and clinical communities to ensure the widest adoption of improved measurement methods and traceability. The project’s PCR reference material has enabled a number of clinical labs to confirm their PCR instruments’ response and gain SI traceability, and the digital PCR technique is now being included in relevant ISO standards. The provision of a metrology framework helps healthcare providers and the biotechnology/diagnostic industry to demonstrate the reliability and robustness of their assays and ultimately supports improved traceability for disease diagnosis and treatment. The research outputs are particularly important for supporting the proposed new network of Reference Laboratories for Class D (infectious pathogens) In Vitro Diagnostic devices (IVDs) and meeting the requirements for metrological traceability in the new EU IVD regulation.