Lauderdale T L, Landers L, Thorneycroft I, Chapin K
Department of Pathology, University of South Alabama, Mobile, Alabama, USA.
J Clin Microbiol. 1999 Jul;37(7):2223-9. doi: 10.1128/JCM.37.7.2223-2229.1999.
Screening for sexually transmitted diseases (STDs) in a greater proportion of sexually active patients has become an accepted protocol by most health care providers. The purpose of this study was to compare the current test methods for detection of Chlamydia trachomatis used at the University of South Alabama, the PACE 2 assay (Gen-Probe) and the Clearview EIA (Wampole Laboratories), with two amplification technologies, the AMP CT (Gen-Probe) and LCx (Abbott) assays. In addition, a number of demographic parameters were ascertained by asking questions at the time of examination as well as for health care provider concerns and preferences. One urine and four endocervical swab specimens were collected in random order from 787 female patients attending one of four obstetrics-gynecology clinics. Eighty-seven percent of patients had no STD-related symptoms. Patients were considered positive for C. trachomatis if three or more assays (swab and/or urine) were positive. Abbott and Gen-Probe confirmed discrepant results by alternate amplified assays. A total of 66 true-positive specimens were detected by use of the combination of endocervical swabs and urine specimens. After discrepant analysis, sensitivities for endocervical swab specimens for the EIA and the PACE 2, LCx, and AMP CT assays were 50, 81, 97, and 100%, respectively. Sensitivities for the LCx and AMP CT assays with urine specimens were 98 and 81%, respectively. The prevalence of C. trachomatis was 8.4%, as determined by amplification technology. Overall, the amplification technologies were the most sensitive methods with either swab (AMP CT assay) or urine (LCx assay) specimens. The PACE 2 assay offered the advantage of a simpler and less expensive assay with acceptable sensitivity. The clearview CT EIA, while yielding a rapid in-office result, had unacceptably low sensitivity. The wide variation in performance with amplification assays with urine specimens as reported in both this study and the literature obviates the need to clarify optimal parameters for this specimen type.
对更大比例的性活跃患者进行性传播疾病（STD）筛查已成为大多数医疗服务提供者认可的方案。本研究的目的是将南阿拉巴马大学目前用于检测沙眼衣原体的检测方法，即PACE 2检测法（基因探针公司）和Clearview酶免疫分析（Wampole实验室），与两种扩增技术，即AMP CT（基因探针公司）和LCx（雅培公司）检测法进行比较。此外，通过在检查时提问以及了解医疗服务提供者的关注点和偏好，确定了一些人口统计学参数。从四家妇产科诊所之一就诊的787名女性患者中随机采集了一份尿液和四份宫颈拭子标本。87%的患者没有与性传播疾病相关的症状。如果三种或更多检测方法（拭子和/或尿液）呈阳性，则患者被视为沙眼衣原体阳性。雅培公司和基因探针公司通过替代扩增检测法确认了不一致的结果。通过宫颈拭子和尿液标本的组合共检测到66份真阳性标本。经过差异分析，酶免疫分析、PACE 2、LCx和AMP CT检测法对宫颈拭子标本的灵敏度分别为50%、81%、97%和100%。LCx和AMP CT检测法对尿液标本的灵敏度分别为98%和81%。通过扩增技术确定沙眼衣原体的患病率为8.4%。总体而言，扩增技术是使用拭子（AMP CT检测法）或尿液（LCx检测法）标本时最敏感的方法。PACE 2检测法具有操作更简单、成本更低且灵敏度可接受的优点。Clearview CT酶免疫分析虽然能在办公室快速得出结果，但其灵敏度低得令人无法接受。本研究和文献中报道的尿液标本扩增检测法性能差异很大，因此无需明确该标本类型的最佳参数。
