Kluytmans J A, Goessens W H, Mouton J W, van Rijsoort-Vos J H, Niesters H G, Quint W G, Habbema L, Stolz E, Wagenvoort J H
Department of Clinical Microbiology, University Hospital Rotterdam Dijkzigt, The Netherlands.
J Clin Microbiol. 1993 Dec;31(12):3204-10. doi: 10.1128/jcm.31.12.3204-3210.1993.
The Clearview Chlamydia test (CV; Unipath Ltd., Bedford, United Kingdom), the Magic Lite Chlamydia test (ML; CIBA Corning, Medfield, Mass.), a polymerase chain reaction (PCR), and cell culture (CC) were evaluated for detection of Chlamydia trachomatis in urogenital specimens. Specimens were collected from 283 men and 724 women visiting the outpatient clinic for Sexually Transmitted Diseases at the University Hospital Rotterdam, Rotterdam, The Netherlands. ML, PCR, and CC were all performed on the same sample to prevent swab-to-swab variability. CV was performed on a separate sample. Analysis of discordant results was performed by application of the following confirmatory assays: first, PCR on the CC, second, ML was repeated, and third, PCR was repeated by using a different DNA extraction protocol. If more than one test was positive, the sample was considered true positive. If only one test was positive, which was confirmed by the confirmatory assay, the sample was also considered true positive. By using these interpretations, the following results were obtained. The sensitivity and specificity of CV for samples from men were 60.4 and 86.3%, respectively. For samples from women, these values were 62.3 and 99.7%, respectively. The low specificity for samples from men was caused by unidentified substances in the swab that was used. The use of CV on samples from men is not recommended by the manufacturer. For samples from women, the specificity of CV was high, but the low sensitivity of CV limits its use for diagnostic purposes. The sensitivities of ML were low for samples from both men and women (68.8% and 50.9% respectively), while specificities were excellent for samples from both groups (100 and 99.9%, respectively). The low sensitivity of ML limits its diagnostic value. The PCR technique was highly specific for samples from both men (99.6%) and women (99.9%). The sensitivity of PCR, however, was unexpectedly low for samples from both groups (men, 87.5%; women, 79.2%), most likely because of the sample treatment method used. The sensitivity and specificity values of CC for samples from men were 95.8 and 100%, respectively. For samples from women, these values were 100 and 99.9%, respectively. In the present study, CC was the most reliable technique for the detection of C. trachomatis.
对Clearview衣原体检测（CV；Unipath有限公司，英国贝德福德）、Magic Lite衣原体检测（ML；CIBA康宁公司，美国马萨诸塞州梅德菲尔德）、聚合酶链反应（PCR）和细胞培养（CC）检测泌尿生殖系统标本中沙眼衣原体的情况进行了评估。标本取自荷兰鹿特丹大学医院性传播疾病门诊的283名男性和724名女性。ML、PCR和CC均对同一样本进行检测，以防止拭子间差异。CV对另一份样本进行检测。对不一致结果采用以下确证试验进行分析：首先，对CC样本进行PCR检测；其次，重复进行ML检测；第三，采用不同的DNA提取方案重复进行PCR检测。如果不止一项检测呈阳性，则该样本被视为真阳性。如果只有一项检测呈阳性且经确证试验证实，则该样本也被视为真阳性。采用这些解读方式得出了以下结果。CV对男性样本的敏感性和特异性分别为60.4%和86.3%。对女性样本而言，这些值分别为62.3%和99.7%。男性样本特异性低是由于所用拭子中存在不明物质。制造商不建议对男性样本使用CV。对于女性样本，CV的特异性较高，但敏感性低限制了其用于诊断目的。ML对男性和女性样本的敏感性均较低（分别为68.8%和50.9%），而两组样本的特异性均极佳（分别为100%和99.9%）。ML敏感性低限制了其诊断价值。PCR技术对男性（99.6%）和女性（99.9%）样本均具有高度特异性。然而，PCR对两组样本的敏感性出人意料地低（男性为87.5%；女性为79.2%），很可能是由于所用的样本处理方法。CC对男性样本的敏感性和特异性值分别为95.8%和100%。对女性样本而言，这些值分别为100%和99.9%。在本研究中，CC是检测沙眼衣原体最可靠的技术。
