Mahilum-Tapay Lourdes, Laitila Vivian, Wawrzyniak James J, Lee Helen H, Alexander Sarah, Ison Catherine, Swain Alison, Barber Penelope, Ushiro-Lumb Ines, Goh Beng T
Diagnostics for the Real World (Europe) Ltd, Cambridge Science Park, Cambridge CB4 0WG.
BMJ. 2007 Dec 8;335(7631):1190-4. doi: 10.1136/bmj.39402.463854.AE. Epub 2007 Nov 30.
To evaluate the performance of a new Chlamydia Rapid Test with vaginal swab specimens as a potential tool for chlamydia diagnosis and screening.
Performance evaluation study. Settings A young people's sexual health centre (site 1) and two genitourinary medicine clinics (sites 2 and 3) in the United Kingdom.
1349 women aged between 16 and 54 attending one of the three clinics.
Sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test versus polymerase chain reaction and strand displacement amplification assays; correlation between the Chlamydia Rapid Test visual signal and organism load; acceptability to participants of self collected vaginal swabs as the specimen type for Chlamydia testing.
Polymerase chain reaction positivity rates for Chlamydia trachomatis infection were 8.4% (56/663) at site 1, 9.4% (36/385) at site 2, and 6.0% (18/301) at site 3. Compared with polymerase chain reaction assay, the resolved sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test were 83.5% (91/109), 98.9% (1224/1238), 86.7% (91/105), and 98.6% (1224/1242). Compared with strand displacement amplification assay, sensitivity and specificity of the Chlamydia Rapid Test were 81.6% (40/49) and 98.3% (578/588). Organism load of self collected vaginal swabs ranged from 5.97x10(2) to 1.09x10(9) Chlamydia plasmids per swab, which correlated well with the Chlamydia Rapid Test's visual signal (r=0.6435, P<0.0001). Most (95.9%) surveyed participants felt comfortable about collecting their own swabs.
The performance of the Chlamydia Rapid Test with self collected vaginal swabs indicates that it would be an effective same day diagnostic and screening tool for Chlamydia infection in women. The availability of Chlamydia Rapid Test results within 30 minutes allows for immediate treatment and contact tracing, potentially reducing the risks of persistent infection and onward transmission. It could also provide a simple and reliable alternative to nucleic acid amplification tests in chlamydia screening programmes.
评估一种新型衣原体快速检测法在使用阴道拭子标本时作为衣原体诊断和筛查潜在工具的性能。
性能评估研究。地点：英国一家青少年性健康中心（地点1）和两家泌尿生殖医学诊所（地点2和3）。
1349名年龄在16至54岁之间、在三家诊所之一就诊的女性。
衣原体快速检测法相对于聚合酶链反应和链置换扩增检测法的敏感性、特异性、阳性预测值和阴性预测值；衣原体快速检测法视觉信号与病原体载量之间的相关性；参与者对自我采集阴道拭子作为衣原体检测标本类型的接受度。
沙眼衣原体感染的聚合酶链反应阳性率在地点1为8.4%（56/663），在地点2为9.4%（36/385），在地点3为6.0%（18/301）。与聚合酶链反应检测法相比，衣原体快速检测法的敏感性、特异性、阳性预测值和阴性预测值分别为83.5%（91/109）、98.9%（1224/1238）、86.7%（91/105）和98.6%（1224/1242）。与链置换扩增检测法相比，衣原体快速检测法的敏感性和特异性分别为81.6%（40/49）和98.3%（578/588）。自我采集阴道拭子的病原体载量范围为每拭子5.97×10²至1.09×10⁹个衣原体质粒，这与衣原体快速检测法的视觉信号相关性良好（r = 0.6435，P < 0.0001）。大多数（95.9%）接受调查的参与者对自行采集拭子感到自在。
使用自我采集阴道拭子的衣原体快速检测法的性能表明，它将是女性衣原体感染的一种有效的当日诊断和筛查工具。30分钟内即可获得衣原体快速检测结果，这使得能够立即进行治疗和接触者追踪，有可能降低持续感染和传播的风险。在衣原体筛查项目中，它还可以为核酸扩增检测提供一种简单可靠的替代方法。
