title: Application of HTB-SiHa cells transfected with a recombinant plasmid for external quality assessment of Chlamydia trachomatis PCR.
abstract: BACKGROUND
  The participation of laboratories in external quality assessment (EQA) programs is required for the quality assurance of nucleic acid amplification of Chlamydia trachomatis. This study aimed to construct a new quality control (QC) material applicated in EQA of C. trachomatis PCR.
  
  
  METHODS
  A QC material-HTB-SiHa cells transfected with a recombinant plasmid containing the cryptic plasmid sequence-was constructed for C. trachomatis PCR detection, and four different panels, each consisting of 4 positive samples with serial dilution of the constructed QC material and 1 negative sample, were distributed by the National Center for Clinical Laboratories among four groups of 275, 268, 317, and 304 participants across China from 2011 through 2012. A total of eight commercial kits were used for C. trachomatis PCR detection in participants.
  
  
  RESULTS
  Nine laboratories reported false-positive results (0.9%). As the series dilution increased, the correct reporting of the data sets decreased; the lowest correct rate was 96.3% in the weakest positive samples (10(4) copies/mL). Eight laboratories reported false-positive results, and 42 laboratories reported false-negative results in the EQA detection of C. trachomatis. No significant differences were observed in the detection of the constructed C. trachomatis positive samples (97.9%, 98.5%, 100%, 98.5%; P=0.36) and negative samples (100%, 99.0%, 100%, 99.0%; P=0.764) using four commercial kits commonly used in China.
  
  
  CONCLUSIONS
  The results of the EQA study indicated that the constructed material provides a noninfectious, stable control material with sufficient volume for PCR detection of C. trachomatis.
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, China.
authors.forename: Kuo
authors.initials: K
authors.lastname: Zhang
authors.affiliation: Department of Clinical Laboratory, Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences, Beijing, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Huo
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Sun
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, China.
authors.forename: Lunan
authors.initials: L
authors.lastname: Wang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Zhang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, China.
authors.forename: Guigao
authors.initials: G
authors.lastname: Lin
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, China.
authors.forename: Jiehong
authors.initials: J
authors.lastname: Xie
authors.affiliation: Department of Clinical Laboratory, Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences, Beijing, China.
authors.forename: Qingtao
authors.initials: Q
authors.lastname: Wang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing, China.
authors.forename: Jinming
authors.initials: J
authors.lastname: Li
mesh_terms: D002460:Cell Line; D002690:Chlamydia Infections / Q000175:diagnosis; D002692:Chlamydia trachomatis / Q000235:genetics*; D004269:DNA, Bacterial / Q000032:analysis*; D005188:False Negative Reactions; D006801:Humans; D007753:Laboratories / Q000592:standards*; D010957:Plasmids / Q000235:genetics / Q000378:metabolism*; D016133:Polymerase Chain Reaction / Q000592:standards*; D011786:Quality Control; D011933:Reagent Kits, Diagnostic
chemical_list: D004269:DNA, Bacterial; D011933:Reagent Kits, Diagnostic
keywords: Chlamydia trachomatis; Epithelial cells; External Quality Assessment; Polymerase chain reaction; Quality control