title: Use and evaluation of molecular diagnostics for pneumonia etiology studies.
abstract: Comprehensive microbiological testing will be a core function of the Pneumonia Etiology Research for Child Health (PERCH) project. The development stage of PERCH provided the time and resources necessary for us to conduct a comprehensive review of the current state of respiratory diagnostics. These efforts allowed us to articulate the unique requirements of PERCH, establish that molecular methods would be central to our testing strategy, and focus on a short list of candidate platforms. This process also highlighted critical challenges in the general design and interpretation of diagnostic evaluation studies, particularly in the field of respiratory infections. Although our final molecular diagnostic platform was ultimately selected on the basis of operational and strategic considerations determined by the specific context of PERCH, our review highlighted several conceptual and practical challenges in respiratory diagnostics that have broader relevance for the performance and interpretation of pneumonia research studies.
authors.affiliation: Department of International Health, Johns Hopkins Bloomberg School of Public Health.
authors.forename: Niranjan
authors.initials: N
authors.lastname: Bhat
authors.forename: Katherine L
authors.initials: KL
authors.lastname: O'Brien
authors.forename: Ruth A
authors.initials: RA
authors.lastname: Karron
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Driscoll
authors.forename: David R
authors.initials: DR
authors.lastname: Murdoch
mesh_terms: D001419:Bacteria / Q000302:isolation & purification; D001424:Bacterial Infections / Q000175:diagnosis / Q000382:microbiology; D006801:Humans; D008828:Microbiological Techniques / Q000379:methods* / Q000592:standards; D025202:Molecular Diagnostic Techniques / Q000379:methods* / Q000592:standards; D011014:Pneumonia / Q000175:diagnosis / Q000209:etiology*; D011786:Quality Control; D012141:Respiratory Tract Infections / Q000175:diagnosis* / Q000382:microbiology / Q000821:virology; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods / Q000592:standards; D013997:Time Factors; D014777:Virus Diseases / Q000175:diagnosis / Q000821:virology; D014780:Viruses / Q000302:isolation & purification