Parallel comparison of 7 kinds of domestic Chlamydia trachomatis nucleic acid test reagents

doi:10.3969/j.issn.1673-8640.2018.12.005

Abstract

Abstract:

Objective To investigate the performance of domestic Chlamydia trachomatis nucleic acid test reagents,and to provide a reference for clinic.Methods For parallel comparison,7 kinds of domestic Chlamydia trachomatis nucleic acid test were selected to analyze the clinical swab samples with different levels of Chlamydia trachomatis. E and D reagents were used as reference. The DNA from 101 clinical swab samples were amplified,and the performance of various reagents were analyzed.Results The 2 reference reagants had consistent results for the 101 clinical swab samples. Compared to the results of the 2 reference reagents,the sensitivities for the other 5 reagents were 88.89%-100.00%,and the specificities were 97.59%-100.00%. There was difference for sensitivities between the other 5 reagents and the 2 reference reagents without statistical significance（P>0.05）.Conclusions The 7 domestic reagents have different sensitivities,some reagents have poor performance for determining low-level samples,and the sensitivity and specificity for some reagents should be improved for the screening of Chlamydia trachomatis infection,further considering non-invasive samples.

Key words: Chlamydia trachomatis, Nucleic acid test, Reagent, Parallel comparison

CLC Number:

R446.61

CHEN Kai, HAN Yan, YIN Yueping, ZHONG Mingying, ZHU Bangyong, SHI Meiqin. Parallel comparison of 7 kinds of domestic Chlamydia trachomatis nucleic acid test reagents[J]. Laboratory Medicine, 2018, 33(12): 1081-1085.

Figures/Tables 5

References 12

1	NEWMAN L,ROWLEY J,VANDER HOORN S,et al.Global estimates of the prevalence and incidence of four curable sexually transmitted infections in 2012 based on systematic review and global reporting[J]. PLoS One,2015,10(12):e0143304.
2	LANJOUW E,OUBURG S,DE VRIES H J,et al.2015 European guideline on the management of Chlamydia trachomatis infections[J]. Int J STD AIDS,2016,27(5):333-348.
3	Centers for Disease Control and Prevention. Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae--2014[J]. MMWR Recomm Rep,2014,63(RR-02):1-19.
4	王雪亮,刘芬,蒋玲丽,等. 环介导等温扩增技术快速检测沙眼衣原体[J]. 检验医学,2017,32(9):809-812.
5	MOORE E R. Sphingolipid trafficking and purification in Chlamydia trachomatis-infected cells[J].Curr Protoc Microbiol,2012,11:11A. 2.
6	赵广录,张娟娟,王峰,等. 五种不同沙眼衣原体实验室筛查试剂检测性能评价[J]. 中国艾滋病性病,2012,18(2):109-112.
7	PARRA-SÁNCHEZ M,PALOMARES J C,BERNAL S,et al. Evaluation of the cobas 4800 CT/NG test for detecting Chlamydia trachomatis and Neisseria gonorrhoeae DNA in urogenital swabs and urine specimens[J]. Diagn Microbiol Infect Dis,2012,74(4):338-342.
8	HAN Y,YIN Y P,SHI M Q,et al.Evaluation of Abbott RealTime CT/NG assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in cervical swabs from female sex workers in China[J]. PLoS One,2014,9(3):e89658.
9	GAYDOS C A,VAN DER POL B,JETT-GOHEEN M,et al.Performance of the Cepheid CT/NG Xpert rapid PCR test for detection of Chlamydia trachomatis and Neisseria gonorrhoeae[J]. J Clin Microbiol,2013,51(6):1666-1672.
10	SCHACHTER J.NAATs to diagnose Chlamydia trachomatis genital infection:a promise still unfulfilled[J]. Expert Rev Mol Diagn,2001,1(2):137-144.
11	KEIJZER H,ENDENBURG S C,SMITS M G,et al.Automated genomic DNA extraction from saliva using the QIAxtractor[J]. Clin Chem Lab Med,2010,48(5):641-643.
12	RIPA T,NILSSON P. A variant of Chlamydia trachomatis with deletion in cryptic plasmid:implications for use of PCR diagnostic tests[J]. Euro Surveill,2006,11(11):E061109.2.

试剂	DNA量（µL）	性质	质控品	最低检测限
A	4	定性	生理盐水和基因组DNA	500 拷贝/mL
B	2	定性	灭菌注射用水和克隆质粒	20 拷贝/mL
C	5	定量	内标、临床阳性和阴性样本	400 拷贝/mL
D	6	定性	生理盐水、阳性质粒
E	4	定性	内标、生理盐水和基因组DNA	500 拷贝/mL
F	5	定量	核酸稀释液、含目的基因的质粒	500 拷贝/mL
G	2	定量	阴性（生理盐水）、临界和强阳	10 个/μL

试剂	DNA量（µL）	性质	质控品	最低检测限
A	4	定性	生理盐水和基因组DNA	500 拷贝/mL
B	2	定性	灭菌注射用水和克隆质粒	20 拷贝/mL
C	5	定量	内标、临床阳性和阴性样本	400 拷贝/mL
D	6	定性	生理盐水、阳性质粒
E	4	定性	内标、生理盐水和基因组DNA	500 拷贝/mL
F	5	定量	核酸稀释液、含目的基因的质粒	500 拷贝/mL
G	2	定量	阴性（生理盐水）、临界和强阳	10 个/μL

定量样本	A试剂	B试剂	C试剂	D试剂	E试剂	F试剂	G试剂
阴性						>33	>37
10¹拷贝/mL			27.16	33.97	35.45	>33	34.96
10²拷贝/mL	>37	>40	24.18	33.60	34.06	>33	32.02
10³拷贝/mL	36.71	>40	24.07	31.33	32.84	>33	33.84
10⁴拷贝/mL	34.02	>40	22.75	28.69	30.37	31.81	31.26
10⁵拷贝/mL	30.60	37.48	20.21	25.36	27.60	29.22	28.13
10⁶拷贝/mL	27.67	33.78	16.76	23.26	24.60	26.70	25.15
10⁷拷贝/mL	24.34	31.77	14.00	20.26	21.29	22.02	22.00
10⁸拷贝/mL	21.60	31.25	11.10	17.31	18.56	21.22	19.01
评判标准	≤37	≤40	≤30	≤37	≤38	≤33	<37

定量样本	A试剂	B试剂	C试剂	D试剂	E试剂	F试剂	G试剂
阴性						>33	>37
10¹拷贝/mL			27.16	33.97	35.45	>33	34.96
10²拷贝/mL	>37	>40	24.18	33.60	34.06	>33	32.02
10³拷贝/mL	36.71	>40	24.07	31.33	32.84	>33	33.84
10⁴拷贝/mL	34.02	>40	22.75	28.69	30.37	31.81	31.26
10⁵拷贝/mL	30.60	37.48	20.21	25.36	27.60	29.22	28.13
10⁶拷贝/mL	27.67	33.78	16.76	23.26	24.60	26.70	25.15
10⁷拷贝/mL	24.34	31.77	14.00	20.26	21.29	22.02	22.00
10⁸拷贝/mL	21.60	31.25	11.10	17.31	18.56	21.22	19.01
评判标准	≤37	≤40	≤30	≤37	≤38	≤33	<37

编号	E试剂	D试剂	A试剂	C试剂	G试剂	F试剂	B试剂
450100-003	+	+	+	+	-	-	+
450100-007	-	-	-	-	-	-	+
450100-055	-	-	-	+	-	-	-
450100-110	-	-	-	-	-	+	-
450100-112	+	+	+	+	+	-	+
450100-150	+	+	-	+	+	+	-
450100-194	-	-	-	-	-	+	-