title: External quality assessment for the molecular detection of MERS-CoV in China.
abstract: BACKGROUND
  In May 2015, an imported case of Middle East respiratory syndrome coronavirus (MERS-CoV) infection occurred in China, so rapid and reliable diagnosis of suspected cases was necessary.
  
  
  OBJECTIVE
  An external quality assessment (EQA) program for the molecular detection of MERS-CoV was organized by the National Center for Clinical Laboratories (NCCL).
  
  
  METHODS
  MS2 virus-like particles (VLPs) encapsulating specific RNA sequences of MERS-CoV were prepared as positive specimens. The assessment panel, which comprised of three negative and seven positive samples with different concentrations of VLPs, was distributed to 56 laboratories from 16 provinces, municipalities, or autonomous regions for molecular detection.
  
  
  RESULTS
  Among the received data sets, three employed an in-house-developed real-time reverse-transcription polymerase chain reaction (rRT-PCR) assay and the others applied various commercial rRT-PCR kits. Overall, the majority of laboratories (46/56, 82.1%) could achieve 100% accuracy for MERS-CoV detection, but three laboratories (5.4%) still had room for improvement. Consequently, all negative samples were identified correctly, reaching 100% specificity. The false-negative rate was 3.1%, and most of the false-negative results were obtained from samples with relatively low concentration, indicating an urgent need to improve detection in weak-positive specimens.
  
  
  CONCLUSIONS
  The majority of participants possessed reliable diagnostic capacity for the detection of MERS-CoV. Moreover, EQA is indispensable because it can help enhance the diagnostic capability for the surveillance of MERS-CoV infections and allow comparison of the results among different laboratories.
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, PR China; Peking University Fifth School of Clinical Medicine, Beijing, PR China.
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, PR China; Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, PR China.
authors.forename: Mingju
authors.initials: M
authors.lastname: Hao
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, PR China.
authors.forename: Kuo
authors.initials: K
authors.lastname: Zhang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, PR China.
authors.forename: Rui
authors.initials: R
authors.lastname: Zhang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, PR China.
authors.forename: Guigao
authors.initials: G
authors.lastname: Lin
authors.affiliation: Department of Clinical Laboratory, Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences, Beijing, PR China.
authors.forename: Tingting
authors.initials: T
authors.lastname: Jia
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, PR China; Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, PR China.
authors.forename: Dong
authors.initials: D
authors.lastname: Zhang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, PR China; Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, PR China.
authors.forename: Le
authors.initials: L
authors.lastname: Chang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, PR China.
authors.forename: Jiehong
authors.initials: J
authors.lastname: Xie
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, PR China; Peking University Fifth School of Clinical Medicine, Beijing, PR China. Electronic address: jmli@nccl.org.cn.
authors.forename: Jinming
authors.initials: J
authors.lastname: Li
mesh_terms: D002681:China; D006801:Humans; D065207:Middle East Respiratory Syndrome Coronavirus / Q000235:genetics / Q000302:isolation & purification*; D025202:Molecular Diagnostic Techniques; D016730:Program Development; D011785:Quality Assurance, Health Care; D012367:RNA, Viral / Q000235:genetics; D060888:Real-Time Polymerase Chain Reaction; D012015:Reference Standards; D012016:Reference Values; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral
keywords: External quality assessment; MERS-CoV; MS2 virus-like particles; Molecular diagnosis; Real time RT-PCR