采用 Strand Displacement Assay（SDA）比较女性人群中段尿样本和宫颈拭子用于沙眼衣原体检测。
Comparing urine samples and cervical swabs for Chlamydia testing in a female population by means of Strand Displacement Assay (SDA).
机构信息
Department of Public Health, University of Bergen, Norway.
出版信息
BMC Womens Health. 2010 Mar 25;10:9. doi: 10.1186/1472-6874-10-9.
BACKGROUND
There has been an increasing number of diagnosed cases of Chlamydia trachomatis in many countries, in particular among young people. The present study was based on a growing request to examine urine as a supplementary or primary specimen in screening for Chlamydia trachomatis in women, with the Becton Dickinson ProbeTec (BDPT) Strand Displacement Assay (SDA). Urine samples may be particularly important in screening young people who are asymptomatic.
METHODS
A total of 603 women aged 15 and older were enrolled from the Sexually Transmitted Infection (STI) clinic at Haukeland University Hospital, Norway, in 2007. Only 31 women were older than 35 years. Cervical swabs and urine samples were tested with BDPT for all participants. In cases of discrepant test results from a given patient, both samples were retested by Cobas TaqManCT and a Polymerase Chain Reaction (PCR)-method (in-house). Prevalence of C. trachomatis, sensitivity, and specificity were estimated by latent class analysis using all test results available. Bootstrap BC confidence intervals (10,000 computations) were estimated for sensitivity and specificity, and their differences in cervix vs. urine tests.
RESULTS
A total of 1809 specimens were collected from 603 patients. 80 women (13.4%) were positive for C. trachomatis. Among these, BDPT identified 72 and 73 as positive in cervix and urine samples, respectively. Of the 523 C. trachomatis negative women, BDPT identified 519 as negative based on cervical swabs, and 514 based on urine samples. Sensitivity for cervical swabs and urine samples with the BDPT were 89.0% (95% CI 78.8, 98.6) and 90.2% (95% CI 78.1, 95.5), respectively. The corresponding values for specificity were 99.2% (95% CI 98.3, 100) and 98.3% (95% CI 96.4, 100).
CONCLUSIONS
This study indicates that urine specimens are adequate for screening high-risk groups for C. trachomatis by the SDA method (BDPT). Such an approach may facilitate early detection and treatment of the target groups for screening, and be cost-effective for patients and the health services.
背景
在许多国家，包括年轻人在内，越来越多的人被诊断出患有沙眼衣原体。本研究基于越来越多的要求，即使用 Becton Dickinson ProbeTec (BDPT) 链置换检测法（SDA）检查尿液作为沙眼衣原体筛查的补充或主要标本。尿液样本在筛查无症状的年轻人时可能特别重要。
方法
2007 年，挪威豪克兰德大学医院性传播感染（STI）诊所共招募了 603 名 15 岁及以上的女性。只有 31 名女性年龄大于 35 岁。对所有参与者均用 BDPT 检测宫颈拭子和尿液样本。对于来自特定患者的不一致的检测结果，均用 Cobas TaqManCT 和聚合酶链反应（PCR）方法（内部）进行重复检测。使用所有可用的检测结果，通过潜在类别分析估计沙眼衣原体的患病率、敏感性和特异性。使用 10,000 次计算估计敏感性和特异性的引导 BC 置信区间，并估计宫颈与尿液检测的敏感性和特异性差异。
结果
从 603 名患者中采集了 1809 个标本。80 名女性（13.4%）沙眼衣原体阳性。其中，BDPT 在宫颈和尿液样本中分别鉴定出 72 例和 73 例阳性。在 523 例沙眼衣原体阴性的女性中，BDPT 在宫颈拭子上鉴定出 519 例阴性，在尿液样本上鉴定出 514 例阴性。宫颈拭子和尿液样本的 BDPT 敏感性分别为 89.0%（95%CI 78.8,98.6）和 90.2%（95%CI 78.1,95.5）。相应的特异性值分别为 99.2%（95%CI 98.3,100）和 98.3%（95%CI 96.4,100）。
结论
本研究表明，SDA 法（BDPT）的尿液标本可用于筛查沙眼衣原体高危人群。这种方法可能有助于早期发现和治疗目标筛查人群，并为患者和卫生服务机构节省成本。
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