Application of HTB-SiHa Cells Transfected with a Recombinant Plasmid for External Quality Assessment of Chlamydia trachomatis PCR.
10.3343/alm.2014.34.5.360
- Author:
Kuo ZHANG
1
;
Hong HUO
;
Yu SUN
;
Lunan WANG
;
Rui ZHANG
;
Guigao LIN
;
Jiehong XIE
;
Qingtao WANG
;
Jinming LI
Author Information
1. National Center for Clinical Laboratories, Beijing Hospital, Beijing, China. jmli63hn@gmail.com
- Publication Type:Original Article ; Research Support, Non-U.S. Gov't
- Keywords:
Chlamydia trachomatis;
Polymerase chain reaction;
Quality control;
Epithelial cells;
External Quality Assessment
- MeSH:
Cell Line;
Chlamydia Infections/diagnosis;
Chlamydia trachomatis/*genetics;
DNA, Bacterial/*analysis;
False Negative Reactions;
Humans;
Laboratories/*standards;
Plasmids/genetics/*metabolism;
Polymerase Chain Reaction/*standards;
Quality Control;
Reagent Kits, Diagnostic
- From:Annals of Laboratory Medicine
2014;34(5):360-366
- CountryRepublic of Korea
- Language:English
-
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.
