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基于超敏诊断的无症状疟疾患病率和流行病学特征:一项横断面研究。

Prevalence and Epidemiological Characteristics of Asymptomatic Malaria Based on Ultrasensitive Diagnostics: A Cross-sectional Study.

机构信息

Ethiopian Public Health Institute, Addis Ababa University, Ethiopia.

Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Ethiopia.

出版信息

Clin Infect Dis. 2019 Aug 30;69(6):1003-1010. doi: 10.1093/cid/ciy1005.

Abstract

BACKGROUND

As the global public-health objectives for malaria evolve from malaria control towards malaria elimination, there is increasing interest in the significance of asymptomatic infections and the optimal diagnostic test to identify them.

METHOD

We conducted a cross-sectional study of asymptomatic individuals (N = 562) to determine the epidemiological characteristics associated with asymptomatic malaria. Participants were tested by rapid diagnostic tests (CareStart, Standard Diagnostics [SD] Bioline, and Alere ultrasensitive RDT [uRDT]), loop-mediated isothermal amplification (LAMP), and quantitative reverse transcription polymerase chain reaction (qRT-PCR) to determine malaria positivity. Hemoglobin values were recorded, and anemia was defined as a binary variable, according to World Health Organization guidelines.

RESULTS

Compared to reference qRT-PCR, LAMP had the highest sensitivity (92.6%, 95% confidence interval [CI] 86.4-96.5), followed by uRDT Alere Malaria (33.9%, 95% CI 25.5-43.1), CareStart Malaria (14.1%, 95% CI 8.4-21.5), microscopy (5.0%, 95% CI 1.8-10.5), and SD Bioline (5.0%, 95% CI 1.8-10.5). For Plasmodium falciparum specimens only, the sensitivity for uRDT Alere Malaria was 50.0% (95% CI 38.8-61.3) and SD Bioline was 7.3% (95% CI 2.7-15.3). Based on multivariate regression analysis with qRT-PCR as the gold standard, for every 3.2% increase in the prevalence of asymptomatic malaria, hemoglobin decreased by 1 gram per deciliter (prevalence ratio 0.968, 95% CI 0.940-0.997; P = .032). Deletions (4.8%) in hrp2 were noted.

CONCLUSIONS

While uRDT Alere Malaria has superior sensitivity to rapid diagnostic tests and microscopy in detecting asymptomatic malaria, LAMP is superior still. Ultrasensitive diagnostics provide the accurate prevalence estimates of asymptomatic malaria required for elimination.

摘要

背景

随着全球疟疾防控目标从疟疾控制向疟疾消除转变,无症状感染的重要性以及用于识别无症状感染者的最佳诊断检测方法越来越受到关注。

方法

我们进行了一项横断面研究,纳入了 562 名无症状个体,旨在确定与无症状疟疾相关的流行病学特征。参与者接受了快速诊断检测(CareStart、Standard Diagnostics [SD] Bioline 和 Alere 超敏 RDT [uRDT])、环介导等温扩增(LAMP)和实时荧光定量聚合酶链反应(qRT-PCR)检测,以确定疟疾阳性。记录血红蛋白值,并根据世界卫生组织指南将贫血定义为二分类变量。

结果

与参考 qRT-PCR 相比,LAMP 的敏感性最高(92.6%,95%置信区间 [CI] 86.4-96.5),其次是 uRDT Alere Malaria(33.9%,95% CI 25.5-43.1)、CareStart Malaria(14.1%,95% CI 8.4-21.5)、显微镜(5.0%,95% CI 1.8-10.5)和 SD Bioline(5.0%,95% CI 1.8-10.5)。对于仅检测恶性疟原虫的标本,uRDT Alere Malaria 的敏感性为 50.0%(95% CI 38.8-61.3),而 SD Bioline 的敏感性为 7.3%(95% CI 2.7-15.3)。基于以 qRT-PCR 为金标准的多变量回归分析,无症状疟疾的流行率每增加 3.2%,血红蛋白就会降低 1 克/分升(患病率比 0.968,95% CI 0.940-0.997;P =.032)。检测到 hrp2 缺失(4.8%)。

结论

虽然 uRDT Alere Malaria 检测无症状疟疾的敏感性高于快速诊断检测和显微镜,但 LAMP 的敏感性更高。超敏诊断可提供消除疟疾所需的无症状疟疾准确流行率估计。

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