一项针对女性生殖道沙眼衣原体感染的 30 分钟核酸扩增即时检测：一项前瞻性、多中心诊断准确性研究。
A 30-Min Nucleic Acid Amplification Point-of-Care Test for Genital Chlamydia trachomatis Infection in Women: A Prospective, Multi-center Study of Diagnostic Accuracy.
机构信息
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK; Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK.
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK.
出版信息
EBioMedicine. 2018 Feb;28:120-127. doi: 10.1016/j.ebiom.2017.12.029. Epub 2018 Jan 10.
BACKGROUND
Rapid Point-Of-Care Tests for Chlamydia trachomatis (CT) may reduce onward transmission and reproductive sexual health (RSH) sequelae by reducing turnaround times between diagnosis and treatment. The io® single module system (Atlas Genetics Ltd.) runs clinical samples through a nucleic acid amplification test (NAAT)-based CT cartridge, delivering results in 30min.
METHODS
Prospective diagnostic accuracy study of the io® CT-assay in four UK Genito-Urinary Medicine (GUM)/RSH clinics on additional-to-routine self-collected vulvovaginal swabs. Samples were tested "fresh" within 10days of collection, or "frozen" at -80°C for later testing. Participant characteristics were collected to assess risk factors associated with CT infection.
RESULTS
CT prevalence was 7.2% (51/709) overall. Sensitivity, specificity, positive and negative predictive values of the io® CT assay were, respectively, 96.1% (95% Confidence Interval (CI): 86.5-99.5), 97.7% (95%CI: 96.3-98.7), 76.6% (95%CI: 64.3-86.2) and 99.7% (95%CI: 98.9-100). The only risk factor associated with CT infection was being a sexual contact of an individual with CT.
CONCLUSIONS
The io® CT-assay is a 30-min, fully automated, high-performing NAAT currently CE-marked for CT diagnosis in women, making it a highly promising diagnostic to enable specific treatment, initiation of partner notification and appropriately intensive health promotion at the point of care.
背景
沙眼衣原体（CT）即时检测可通过减少诊断和治疗之间的周转时间，降低性传播和生殖健康（RSH）后遗症的发生率。io® 单模块系统（Atlas Genetics Ltd.）通过基于核酸扩增试验（NAAT）的 CT 试剂盒对临床样本进行检测，可在 30 分钟内得出结果。
方法
在英国四家生殖泌尿系统医学（GUM）/RSH 诊所，对常规自我采集的外阴阴道拭子进行了 io® CT 检测的前瞻性诊断准确性研究。样本在采集后 10 天内“新鲜”检测，或在-80°C 冷冻保存以备后续检测。收集参与者特征以评估与 CT 感染相关的风险因素。
结果
CT 总流行率为 7.2%（51/709）。io® CT 检测的灵敏度、特异性、阳性预测值和阴性预测值分别为 96.1%（95%置信区间（CI）：86.5-99.5）、97.7%（95%CI：96.3-98.7）、76.6%（95%CI：64.3-86.2）和 99.7%（95%CI：98.9-100）。唯一与 CT 感染相关的风险因素是与 CT 感染者有性接触。
结论
io® CT 检测是一种 30 分钟、全自动、高性能的 NAAT，目前已在欧盟获得 CE 标志，可用于女性 CT 诊断，是一种极具前景的诊断方法，可在护理点进行针对性治疗、启动性伴侣通知和适当强化健康促进。
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