title: Fast preparation of a long chimeric armored RNA as controls for external quality assessment for molecular detection of Zika virus.
abstract: BACKGROUND
  The emergence of Zika virus demands accurate laboratory diagnostics. Nucleic acid testing is currently the definitive method for diagnosis of Zika infection. In 2016, an external quality assurance (EQA) for assessing the quality of molecular testing of Zika virus was carried out in China.
  
  
  METHODS
  A single armored RNA encapsulating a 4942-nucleotides (nt) long specific RNA sequence of Zika virus was prepared and used as positive samples. A pre-tested EQA panel, consisting of 4 negative and 6 positive samples with different concentrations of armored RNA, was distributed to 38 laboratories that perform molecular detection of Zika virus.
  
  
  RESULTS
  A total of 39 data sets (1 laboratory used two test kits in parallel), produced by using commercial (n=38) or laboratory developed (n=1) quantitative reverse-transcriptase PCR (qRT-PCR) kits, were received. Of these, 35 (89.7%) had correct results for all 10 samples, and 4 (10.3%) reported at least 1 error (11 in total). The testing errors were all false-negatives, highlighting the need of improvements in detecting sensitivity.
  
  
  CONCLUSIONS
  The EQA reveals that the majority of participating laboratories are proficient in molecular testing of Zika virus.
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, PR China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, China. Electronic address: linguigao1982@163.com.
authors.forename: Guigao
authors.initials: G
authors.lastname: Lin
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, PR China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, China. Electronic address: sarahkuo@163.com.
authors.forename: Kuo
authors.initials: K
authors.lastname: Zhang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, PR China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, China. Electronic address: danwin_0607@163.com.
authors.forename: Dong
authors.initials: D
authors.lastname: Zhang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, PR China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, China. Electronic address: hanyanxicici@163.com.
authors.forename: Yanxi
authors.initials: Y
authors.lastname: Han
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, PR China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, China. Electronic address: jhxie@nccl.org.cn.
authors.forename: Jiehong
authors.initials: J
authors.lastname: Xie
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, PR China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, China. Electronic address: jmli@nccl.org.cn.
authors.forename: Jinming
authors.initials: J
authors.lastname: Li
mesh_terms: D002681:China; D019411:Clinical Laboratory Techniques; D005188:False Negative Reactions; D006801:Humans; D015588:Observer Variation; D011786:Quality Control; D012367:RNA, Viral / Q000138:chemical synthesis / Q000592:standards*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D000071244:Zika Virus / Q000302:isolation & purification*; D000071243:Zika Virus Infection / Q000175:diagnosis*
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: Armored RNA; External quality assessment; Molecular diagnosis; Zika virus