title: Clinical evaluation of a new single-tube multiplex reverse transcription PCR assay for simultaneous detection of 11 respiratory viruses, Mycoplasma pneumoniae and Chlamydia in hospitalized children with acute respiratory infections.
abstract: Respiratory Pathogen 13 Detection Kit (13× kit) is able to simultaneously detect 11 respiratory viruses, Mycoplasma pneumoniae (MP) and Chlamydia in a single reaction. Using 572 Nasopharyngeal aspirates collected from hospitalized children, the clinical performance of 13× kit for detecting 11 respiratory viruses was evaluated in comparison with a routinely used 2-tube multiplex reverse transcription PCR assay (2-tube assay) at provincial Centers for Disease Control and Prevention in China. The clinical performance of 13× kit for detecting MP and Chlamydia was evaluated by commercial real-time quantitative PCR (qPCR) kits or sequencing. For tested viruses, the assay concordance was 95.98% and the kappa coefficient was 0.89. All the MP and Chlamydia positive samples detected by 13× kit were confirmed as true positives. The utilization of the 13× kit in clinical settings will be helpful for doctors to assess clinical outcome according to virus type or multiple infections, and to limit the use of antibiotics.
authors.affiliation: Pediatric Research Institute, Children's Hospital of Hebei Province, Shijiazhuang, 050031, Hebei Province, China; Key Laboratory for Medical Virology, National Health and Family Planning Commission, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206,China. Electronic address: zhaomengchuan1989@163.com.
authors.forename: Meng-Chuan
authors.initials: MC
authors.lastname: Zhao
authors.affiliation: Pediatric Research Institute, Children's Hospital of Hebei Province, Shijiazhuang, 050031, Hebei Province, China. Electronic address: 13832179762@139.com.
authors.forename: Gui-Xia
authors.initials: GX
authors.lastname: Li
authors.affiliation: Key Laboratory for Medical Virology, National Health and Family Planning Commission, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206,China. Electronic address: zhangdan9769@163.com.
authors.forename: Dan
authors.initials: D
authors.lastname: Zhang
authors.affiliation: Key Laboratory for Medical Virology, National Health and Family Planning Commission, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206,China. Electronic address: zhouhangyuzi@126.com.
authors.forename: Hang-Yu
authors.initials: HY
authors.lastname: Zhou
authors.affiliation: Key Laboratory for Medical Virology, National Health and Family Planning Commission, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206,China; Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, 41345, Sweden. Electronic address: hao.wang@gu.se.
authors.forename: Hao
authors.initials: H
authors.lastname: Wang
authors.affiliation: Pediatric Research Institute, Children's Hospital of Hebei Province, Shijiazhuang, 050031, Hebei Province, China. Electronic address: hbcheysys@163.com.
authors.forename: Shuo
authors.initials: S
authors.lastname: Yang
authors.affiliation: Pediatric Research Institute, Children's Hospital of Hebei Province, Shijiazhuang, 050031, Hebei Province, China. Electronic address: luka_wl@163.com.
authors.forename: Le
authors.initials: L
authors.lastname: Wang
authors.affiliation: Pediatric Research Institute, Children's Hospital of Hebei Province, Shijiazhuang, 050031, Hebei Province, China. Electronic address: 15131129999@139.com.
authors.forename: Zhi-Shan
authors.initials: ZS
authors.lastname: Feng
authors.affiliation: Key Laboratory for Medical Virology, National Health and Family Planning Commission, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206,China. Electronic address: maxj@ivdc.chinacdc.cn.
authors.forename: Xue-Jun
authors.initials: XJ
authors.lastname: Ma
mesh_terms: D000293:Adolescent; D002648:Child; D002673:Child, Hospitalized; D002675:Child, Preschool; D002689:Chlamydia / Q000235:genetics* / Q000302:isolation & purification; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000382:microbiology; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009177:Mycoplasma pneumoniae / Q000235:genetics* / Q000302:isolation & purification; D017817:Nasal Lavage Fluid / Q000382:microbiology / Q000821:virology; D011019:Pneumonia, Mycoplasma / Q000175:diagnosis* / Q000382:microbiology; D012141:Respiratory Tract Infections / Q000175:diagnosis*; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods*; D014777:Virus Diseases / Q000175:diagnosis*; D014780:Viruses / Q000235:genetics* / Q000302:isolation & purification
keywords: Chlamydia; Co-infection; Evaluation; Multiplex reverse transcription-PCR; Mycoplasma pneumoniae; Respiratory virus