title: Advances in multiplex nucleic acid diagnostics for blood-borne pathogens: promises and pitfalls.
abstract: The large number of blood-borne viruses, bacteria and parasites currently of concern, as well as many newly emerging pathogens, presents a daunting challenge to protection of the safety of blood for transfusion and diagnosing infectious diseases. Focusing on nucleic acid diagnostic tests, multiplex devices are coming into use with many more in various developmental stages that promise to offer solutions to the clinical need. The characteristics, advantages and disadvantages of platforms in clinical use and at the research and development stage are examined here. The presence of multiple assays and associated reagents operating simultaneously on one platform, implementation in traditional clinical laboratories and regulatory review will present special challenges. Fortunately, clinical laboratories have made dramatic technical progress in the last two decades and regulatory agencies have publicly expressed support for development of multiplex devices.
authors.affiliation: a Center for Biologics Evaluation and Research , US FDA , Silver Spring , MD , USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Duncan
authors.affiliation: a Center for Biologics Evaluation and Research , US FDA , Silver Spring , MD , USA.
authors.forename: Moussa
authors.initials: M
authors.lastname: Kourout
authors.affiliation: b Diatherix Laboratories , LLC , Huntsville , AL , USA.
authors.forename: Elena
authors.initials: E
authors.lastname: Grigorenko
authors.affiliation: a Center for Biologics Evaluation and Research , US FDA , Silver Spring , MD , USA.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Fisher
authors.affiliation: a Center for Biologics Evaluation and Research , US FDA , Silver Spring , MD , USA.
authors.forename: Ming
authors.initials: M
authors.lastname: Dong
mesh_terms: D000818:Animals; D001419:Bacteria / Q000302:isolation & purification / Q000472:pathogenicity; D017848:Blood-Borne Pathogens / Q000302:isolation & purification*; D006801:Humans; D009696:Nucleic Acids / Q000302:isolation & purification*; D010271:Parasites / Q000302:isolation & purification / Q000472:pathogenicity; D057089:Pathology, Molecular / Q000639:trends*; D014780:Viruses / Q000302:isolation & purification / Q000472:pathogenicity
chemical_list: D009696:Nucleic Acids
keywords: blood-borne; multiplex diagnostics; nucleic acid tests; pathogen