Development and Evaluation of a Point-of-Care Test in a Low-Resource Setting with High Rates of Chlamydia trachomatis Urogenital Infections in Fiji.
Development and Evaluation of a Point-of-Care Test in a Low-Resource Setting with High Rates of Chlamydia trachomatis Urogenital Infections in Fiji.
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在低资源环境中的电点测试的开发和评估，斐济的沙眼衣原体感染率很高。
DOI：
10.1128/jcm.00182-21
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发表时间：
2021-06-18
影响因子：
9.4
通讯作者：
Mitra D
中科院分区：
文献类型：
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作者：
Dean D;Swaminathan S;Kama M;Goemans S;Faktaufon D;Alnabelseya N;Spelke D;Kahrizi K;Black M;Mitra D
沙眼衣原体是全球性传播感染 (STI) 的主要原因，需要在护理点 (POC) 快速、准确地检测沙眼衣原体，以制定治疗决策，以防止传播和后遗症，包括盆腔炎、宫外孕、输卵管因素不孕和早产。我们开发了一种快速 POC 测试 (POCT)，称为 LH-POCT，它使用核酸的环介导扩增 (LAMP)。我们使用临床医生从一项母研究中收集的、未识别的配对阴道样本与 Cepheid Xpert CT/NG 检测进行了头对头比较，该母研究连续招募了来自斐济卫生和医疗服务部健康中心的有症状和无症状的 18 岁以上女性。样品通过 Xpert CT/NG 检测和 LH-POCT 进行处理，对比较器不知情。通过定量 PCR 解决了差异样品。提供了阴道毛滴虫、念珠菌和细菌性阴道病 (BV) 的详细临床数据和测试。共有来自 327 名女性的 353 个样本。差异解决后沙眼衣原体阳性率为16.7%（59/353），患病率为16.82%（55/327）。 LH-POCT 的 7 个差异样本解析为 4 个假阴性、2 个假阳性和 1 个真阳性。 LH-POCT 的敏感性为 93.65%（95% 置信区间 [CI]，84.53% 至 98.24%），特异性为 99.31%（95% CI，97.53% 至 99.92%）。不一致的样本集中在有阴道分泌物和/或细菌性阴道病的女性中。原型 LH-POCT 工作流程具有出色的性能，满足世界卫生组织 POC 测试的许多 ASSURED 标准，包括 35 分钟的采样到结果时间。我们的 LH-POCT 有望改善全球不同医疗保健环境中预防和控制沙眼衣原体性传播感染的临床实践。
Rapid and precise detection of Chlamydia trachomatis, the leading global cause of sexually transmitted infections (STI), at the point of care (POC) is required for treatment decisions to prevent transmission and sequelae, including pelvic inflammatory disease, ectopic pregnancy, tubal factor infertility, and preterm birth. We developed a rapid POC test (POCT), termed LH-POCT, which uses loop-mediated amplification (LAMP) of nucleic acids. We performed a head-to-head comparison with the Cepheid Xpert CT/NG assay using clinician-collected, deidentified paired vaginal samples from a parent study that consecutively enrolled symptomatic and asymptomatic females over 18 years of age from the Ministry of Health and Medical Services Health Centers in Fiji. Samples were processed by the Xpert CT/NG assay and LH-POCT, blinded to the comparator. Discrepant samples were resolved by quantitative PCR. Deidentified clinical data and tests for Trichomonas vaginalis, Candida, and bacterial vaginosis (BV) were provided. There were a total of 353 samples from 327 females. C. trachomatis positivity was 16.7% (59/353), while the prevalence was 16.82% (55/327) after discrepant resolution. Seven discrepant samples resolved to four false negatives, two false positives, and one true positive for the LH-POCT. The sensitivity of the LH-POCT was 93.65% (95% confidence interval [CI], 84.53% to 98.24%), and specificity was 99.31% (95% CI, 97.53% to 99.92%). Discrepant samples clustered among women with vaginal discharge and/or BV. The prototype LH-POCT workflow has excellent performance, meeting many World Health Organization ASSURED criteria for POC tests, including a sample-to-result time of 35 min. Our LH-POCT holds promise for improving clinical practice to prevent and control C. trachomatis STIs in diverse health care settings globally.
DOI：
10.1093/bioinformatics/btp615
发表时间：
2010-01-01
期刊：
Bioinformatics (Oxford, England)
影响因子：
--
作者：
Qi J;Zhao F;Buboltz A;Schuster SC
通讯作者：
Schuster SC