title: Clinical utility of droplet digital PCR for human cytomegalovirus.
abstract: Human cytomegalovirus (CMV) has historically been the major infectious cause of morbidity and mortality among patients receiving hematopoietic cell or organ transplant. Standard care in a transplant setting involves frequent monitoring of CMV viral load over weeks to months to determine when antiviral treatment may be required. Quantitative PCR (qPCR) is the standard molecular diagnostic method for monitoring. Recently, digital PCR (dPCR) has shown promise in viral diagnostics, although current dPCR systems have lower throughput than qPCR systems. Here, we compare qPCR and droplet digital PCR (ddPCR) for CMV detection in patient plasma samples. Droplet digital PCR exhibits increased precision over qPCR at viral loads of ≥4 log10 with equivalent sensitivity. However, retrospective analysis of longitudinal samples from transplant patients with CMV viral loads near therapeutic thresholds did not provide evidence that the improved precision of ddPCR would be of clinical benefit. Given the throughput advantages of current qPCR systems, a widespread switch to dPCR for CMV monitoring would appear premature.
authors.affiliation: Molecular Virology Laboratory, Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA.
authors.forename: Ruth Hall
authors.initials: RH
authors.lastname: Sedlak
authors.affiliation: Molecular Virology Laboratory, Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Cook
authors.affiliation: Department of Biostatistics, University of Washington, Seattle, Washington, USA.
authors.forename: Anqi
authors.initials: A
authors.lastname: Cheng
authors.affiliation: Molecular Virology Laboratory, Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA Department of Biostatistics, University of Washington, Seattle, Washington, USA The Vaccine and Infectious Disease Institute, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
authors.forename: Amalia
authors.initials: A
authors.lastname: Magaret
authors.affiliation: Molecular Virology Laboratory, Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA The Vaccine and Infectious Disease Institute, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA kjerome@fhcrc.org.
authors.forename: Keith R
authors.initials: KR
authors.lastname: Jerome
mesh_terms: D003587:Cytomegalovirus / Q000302:isolation & purification*; D003586:Cytomegalovirus Infections / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D010949:Plasma / Q000821:virology; D016133:Polymerase Chain Reaction / Q000379:methods*; D066027:Transplant Recipients; D019562:Viral Load / Q000379:methods