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KMID : 1100720140340050360
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Annals of Laboratory Medicine
2014 Volume.34 No. 5 p.360 ~ p.366
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Application of HTB-SiHa Cells Transfected with a Recombinant Plasmid for External Quality Assessment of Chlamydia trachomatis PCR
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Zhang Kuo
Huo Hong
Sun Yu
Wang Lunan
Zhang Rui
Lin Gui-Gao
Xie Jie-Hong
Wang Qing-Tao
Li Jin-Ming
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Abstract
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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.
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KEYWORD
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Chlamydia trachomatis, Polymerase chain reaction, Quality control, Epithelial cells, External Quality Assessment
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