Authors: Hannah Makin, Future Science Group
A recent study published in the The Journal of Molecular Diagnostics evaluated a new OpenArray system for the simultaneous detection of multiple viral, bacterial and protozoan pathogens in human blood samples.
This new OpenArray device offers a potential new platform for molecular diagnostics as a faster, more accurate and flexible tool for pathogen identification.
“New multiplex PCR-based diagnostic technologies aimed at faster and more accurate pathogen identification are increasingly used for detection of respiratory or gastrointestinal pathogens, yet testing for a multitude of pathogens directly in the blood is still at the research stage. This study demonstrated that new technologies can enable early and accurate detection of pathogens directly in blood samples. The engagement and coordination of a number of stakeholders, including regulatory, clinical practitioner, and the diagnostics industry, are necessary for implementation of such disruptive technologies for patient care,” stated the Vice President of Research and Development at Diatherix Laboratories (AL, USA).
In this study, purified nucleic acids from each pathogen with pathogen-spiked human blood and plasma samples were utilized for testing the specificity and analytical sensitivity of this OpenArray device.
Of 92 characterized blood donor specimens, 17 viral pathogens in human plasma samples and 13 bacterial and protozoan pathogens in human blood samples were detected with a 95% accuracy.
No false positive results were observed and the samples that were not detected were revealed to be at the lower end of the detectible range or were indeterminate and therefore qualified for retesting.
Investigator with the US FDA’s Center for Biologics Evaluation and Research, Robert Duncan, commented on the need for such devices in the clinic: “All blood for transfusion must be tested for infectious agents. The increasing number of agents that may infect blood and the recognition that some of them only pose a risk in certain areas or certain times means that new methods to streamline blood testing must be developed. The major feature of our OpenArray device, the ability to test for multiple infectious agents at the same time, could be an answer to that need,
“We need the next generation of superior performance tests that will detect an increasing number of transfusion-transmittable agents in multiplex format with high sensitivity and specificity, robustness, and adaptability to accomplish detection of new pathogens and maintain the safety of blood products. Our goal in this research is to provide a proof of concept that will stimulate device developers to advance new technology for multiple assay testing devices into clinical use.”
Phillip Williamson, VP of Operations and Scientific Affairs, also stated: “As the largest independent blood donor testing organization in the US, Creative Testing Solutions welcomes the opportunity to work with the FDA and others on new research initiatives and clinical trials that will ideally improve blood donor testing and the safety of the US blood supply.”
Sources: Grigorenko E, Fisher C, Patel S et al. Highly Multiplex Real-Time PCR–Based Screening for Blood-Borne Pathogens on an OpenArray Platform. J. Mol. Diagn. Doi: org/10.1016/j.jmoldx.2017.03.004 (2017) Epub ahead of print; www.eurekalert.org/pub_releases/2017-06/e-nte061217.php