Morré S A, Van Valkengoed I G, Moes R M, Boeke A J, Meijer C J, Van den Brule A J
Department of Pathology, Section of Molecular Pathology, University Hospital Vrije Universiteit, Amsterdam, The Netherlands.
J Clin Microbiol. 1999 Oct;37(10):3092-6. doi: 10.1128/JCM.37.10.3092-3096.1999.
This study determined the performances of the LCx (Abbott) and COBAS Amplicor (Roche) tests with urine specimens for the detection of Chlamydia trachomatis in an asymptomatic screening population. Randomly selected women and men (age range, 15 to 40 years) registered in 20 general practices in Amsterdam, The Netherlands, were invited to participate in this study. Urine specimens (n = 2, 906; 1,138 specimens from men and 1,717 specimens from women) were tested for C. trachomatis by the COBAS Amplicor (Roche) and LCx (Abbott) tests. Samples which were positive by only one assay were subjected to discrepant analyses by a third assay (in-house plasmid PCR). By the LCx assay C. trachomatis DNA was detected in urine specimens from 46 of 1,717 women and 29 of 1,138 men, while the COBAS Amplicor detected C. trachomatis DNA in 52 and 35 specimens, respectively. When comparing the LCx and COBAS Amplicor tests, 32 test results (20 for women and 12 for men) were discrepant. After discrepant analyses the following sensitivities, specificities, and positive predictive values were found for the LCx and COBAS Amplicor tests: 78.6 versus 98.8%, 99.7 versus 99.9%, and 88.0 versus 95.4%, respectively. No prominent differences were found between men and women with regard to the test performances. After discrepant analyses the overall prevalences of C. trachomatis in women and men were 3.0 and 2.8%, respectively. For both women and men the prevalence in the younger age groups was higher than that in the older age groups. In conclusion, the COBAS Amplicor tests shows better diagnostic characteristics than the LCx assay for the detection of C. trachomatis in urine specimens from an asymptomatic screening population. In this asymptomatic population the overall prevalence of C. trachomatis was 2.9%.
本研究确定了在无症状筛查人群中,使用尿液标本通过雅培LCx检测法和罗氏COBAS Amplicor检测法检测沙眼衣原体的性能。在荷兰阿姆斯特丹的20家普通诊所登记的年龄在15至40岁之间的随机选择的女性和男性被邀请参加本研究。通过罗氏COBAS Amplicor检测法和雅培LCx检测法对尿液标本(n = 2906;1138份男性标本和1717份女性标本)进行沙眼衣原体检测。仅一种检测呈阳性的样本通过第三种检测方法(内部质粒PCR)进行差异分析。通过LCx检测法,在1717名女性的尿液标本中检测到46例沙眼衣原体DNA,在1138名男性的尿液标本中检测到29例;而COBAS Amplicor检测法分别在52份和35份标本中检测到沙眼衣原体DNA。比较LCx检测法和COBAS Amplicor检测法时,有32个检测结果(女性20个,男性12个)存在差异。差异分析后,LCx检测法和COBAS Amplicor检测法的灵敏度、特异性和阳性预测值分别为:78.6%对98.8%、99.7%对99.9%、88.0%对95.4%。在检测性能方面,男性和女性之间未发现显著差异。差异分析后,女性和男性沙眼衣原体的总体患病率分别为3.0%和2.8%。对于女性和男性,较年轻年龄组的患病率均高于较年长年龄组。总之,对于在无症状筛查人群的尿液标本中检测沙眼衣原体,COBAS Amplicor检测法显示出比LCx检测法更好的诊断特征。在这个无症状人群中,沙眼衣原体的总体患病率为2.9%。