Van Der Pol B, Williams J A, Smith N J, Batteiger B E, Cullen A P, Erdman H, Edens T, Davis K, Salim-Hammad H, Chou V W, Scearce L, Blutman J, Payne W J
Department of Medicine, Division of Infectious Diseases, Indiana University School of Medicine, 545 N. Barnhill Drive, Indianapolis, IN 46202-5124, USA.
J Clin Microbiol. 2002 Oct;40(10):3558-64. doi: 10.1128/JCM.40.10.3558-3564.2002.
Screening for chlamydial and gonococcal infection has been strongly recommended for all sexually active women under the age of 26. Advances in the ability to detect infection by nucleic acid detection techniques have improved access to screening methods in routine clinical practices. To meet the increasing demand for testing, a high-throughput system is desirable. We evaluated the performance of the Hybrid Capture 2 CT/GC (HC2) assay with the Digene Rapid Capture System (HC2-RCS). The results of HC2-RCS for endocervical samples from 330 women were compared to those of culture and the COBAS Amplicor PCR. For detection of chlamydial infection, HC2-RCS had a sensitivity and a specificity similar to those of PCR (P > 0.5) and an improved sensitivity compared to that of culture (P = 0.007). For identification of gonococcal infections, all assays performed similarly (P > 0.5). The performance of HC2-RCS was also compared to that of the manual HC2 format (HC2-M) with these samples and with 911 endocervical samples collected previously. The performance of HC2-RCS was equivalent to that of HC2-M; the overall concordance rates for the detection of chlamydia and gonorrhea were 99.7% (kappa = 0.97) and 99.8% (kappa = 0.97), respectively. When the HC2 assay was performed with a semiautomated system application designed for high throughput, it demonstrated high sensitivity and a high specificity for detection of both Chlamydia trachomatis and Neisseria gonorrhoeae.
强烈建议对所有26岁以下有性行为的女性进行衣原体和淋病奈瑟菌感染筛查。核酸检测技术在检测感染能力方面的进步，改善了常规临床实践中筛查方法的可及性。为满足日益增长的检测需求，一种高通量系统是可取的。我们评估了采用Digene快速捕获系统（HC2-RCS）的杂交捕获2 CT/GC（HC2）检测法的性能。将330名女性宫颈样本的HC2-RCS检测结果与培养法和COBAS Amplicor PCR检测结果进行比较。对于衣原体感染的检测，HC2-RCS的敏感性和特异性与PCR相似（P>0.5），与培养法相比敏感性有所提高（P=0.007）。对于淋病奈瑟菌感染的鉴定，所有检测方法表现相似（P>0.5）。还将这些样本以及之前收集的911份宫颈样本的HC2-RCS性能与手动HC2形式（HC2-M）进行了比较。HC2-RCS的性能与HC2-M相当；衣原体和淋病检测的总体一致性率分别为99.7%（kappa=0.97）和99.8%（kappa=0.97）。当使用专为高通量设计的半自动系统应用进行HC2检测时，它对沙眼衣原体和淋病奈瑟菌的检测均显示出高敏感性和高特异性。
