Advances in multiplex nucleic acid diagnostics for blood-borne pathogens: promises and pitfalls - an update

ABSTRACT

Introduction: Multiplex nucleic acid diagnostics for blood-borne pathogens have moved closer to clinical application in the two years since we first reviewed this topic.

Areas covered: A new emphasis on detecting pathogens directly in a blood sample without culture, coupling PCR amplification to microfluidic devices and higher multiplexing in isothermal amplification are some of the advances. A wholly new approach of correlating host gene expression response with specific infectious agents opens another opportunity for multiplex detection. Established microarrays, which had been the highest multiplicity platform, are being displaced by Next Generation Sequencing (NGS) having potentially no limit to the number of pathogens that it can identify. Greater accessibility of sequencing devices, standardization of bioinformatic analysis pathways and increased acceptance from regulatory authorities are driving this technology.

Expert commentary: The landscape of traditional diagnostics for detection of blood-borne pathogens has changed in the last 5 years. There is no doubt that NSG is recognized as a disruptive technology with a growing repertoire of tools, such as subtyping, resistome analysis, etc., available for clinical microbiology. Increasing acceptance indicates the dominating position of NGS as the future of multiplex molecular diagnostics for blood-borne pathogens.

KEYWORDS:

• Multiplex diagnostics
• nucleic acid tests
• blood-borne
• pathogen

Acknowledgments

We acknowledge the contribution of Sreenivas Gannaram and Ranadhir Dey for preview of the manuscript.

Declaration of interest

R Duncan and C Fisher are employees of the FDA. D Hockman and E Grigorenko are employees of Diatherix. B Lanning is funded as an Oak Ridge Institute for Science and Education Post-Doctoral Fellow at the FDA Center for Biologics Evaluation and Research. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.