Annals of Laboratory Medicine

Korean Society for Laboratory Medicine (대한진단검사의학회)
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Application of HTB-SiHa Cells Transfected with a Recombinant Plasmid for External Quality Assessment of Chlamydia trachomatis PCR

  • Zhang, Kuo (National Center for Clinical Laboratories, Beijing Hospital) ;
  • Huo, Hong (Department of Clinical Laboratory, Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences) ;
  • Sun, Yu (National Center for Clinical Laboratories, Beijing Hospital) ;
  • Wang, Lunan (National Center for Clinical Laboratories, Beijing Hospital) ;
  • Zhang, Rui (National Center for Clinical Laboratories, Beijing Hospital) ;
  • Lin, Guigao (National Center for Clinical Laboratories, Beijing Hospital) ;
  • Xie, Jiehong (National Center for Clinical Laboratories, Beijing Hospital) ;
  • Wang, Qingtao (Department of Clinical Laboratory, Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences) ;
  • Li, Jinming (National Center for Clinical Laboratories, Beijing Hospital)
  • Received : 2013.12.23
  • Accepted : 2014.06.24
  • Published : 2014.09.01
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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 (104 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.

Keywords

Acknowledgement

Supported by : National Natural Science Foundation of China

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