埃塞俄比亚绍阿东部阿达玛地区显微镜检查、疟疾快速诊断检测和聚合酶链反应作为疟疾诊断工具的比较评估：一项横断面研究。

Comparative assessment of microscopy, malaria rapid diagnostic test and polymerase chain reaction as malaria diagnostic tools in Adama Woreda, East shoa zone of Ethiopia: a cross-sectional study.

机构信息

Department of Medical Laboratory Science, Injibara University, Injibara, Ethiopia.

Armauer Hansen Research Institute (Malaria and Neglected Tropical Disease Research Directorate), Addis Ababa, Ethiopia.

出版信息

BMC Infect Dis. 2024 Nov 28;24(1):1363. doi: 10.1186/s12879-024-10173-x.

DOI:10.1186/s12879-024-10173-x

PMID:39609673

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11603952/

Abstract

BACKGROUND

One of the main challenge for controlling the morbidity and mortality related to malaria is the absence of reliable treatment and precise diagnostic tools in malaria-prone regions. Despite the number of diagnostic techniques used, and inconsistent results were found from previous studies. The aim of this study is to assess the effectiveness of 18S nested PCR(Polymerase Chain Reaction),microscopy, and CarestartTMpf/pan RDT(Rapid Diagnostic Tests) as malaria diagnostic methods using Microscopy and 18S nested PCR as reference techniques.

METHODS

A facilities and community based cross-sectional study was conducted in the villages of Batodegama kebele and Adama malaria control center from December 2016 to February 2017. A fingerprick blood sample was collected from each participant for the CarestartTM pf/pan RDT test, microscopy, and dry blood spot (DBS) analysis and 18S nested PCR assay. Data were analyzed using STATA11 to calculate the sensitivity, specificity, predictive values, and accuracy.

RESULTS

Among the 128 asymptomatic patients, 26 (20.3%) were positive for malaria nested 18S PCR, 5 (3.9%) through RDT, and 8 (6.3%) through microscopy. From 202 symptomatic Patients, 55 (27.23%), 26 (12.87%), and 28 (13.86%) individuals were positive for 18S nested PCR, RDT, and microscopy, respectively. Comparative analysis of 18S nested PCR, microscopy, and CarestartTMpf/pan RDT have similar sensitivities of 50% and specificities of 100%.for diagnosing symptomatic malaria infections. Furthermore, species level analysis showed that 18S nested PCR has a higher detection rate of 26 (20.31%) than microscopy 8 (6.25%) and CareStartTM pf/pan RDT 5 (4.1%). The CarestartTMpf/pan RDT had a sensitivity of 15.4% and specificity of 98% in detecting asymptomatic malaria infections. However, the two methods have comparable sensitivities.

CONCLUSIONS

The 18S nested PCR assay showed superior performance in all circumstances. On the other hand, the overall performance of CareStart TM pf/pan RDTs was found to be comparable to that of microscopy. This finding highlights the value of parallel application of CareStart TM pf/pan RDTs and microscopy in a resource-limited setup.

摘要

背景

控制疟疾发病率和死亡率的主要挑战之一是在疟疾流行地区缺乏可靠的治疗方法和精确的诊断工具。尽管使用了多种诊断技术，但以前的研究结果并不一致。本研究旨在评估 18S 巢式 PCR（聚合酶链反应）、显微镜和 CarestartTMpf/pan RDT（快速诊断测试）作为疟疾诊断方法的有效性，以显微镜和 18S 巢式 PCR 为参考技术。

方法

2016 年 12 月至 2017 年 2 月在 Batodegama 可比和阿达玛疟疾控制中心进行了基于设施和社区的横断面研究。从每个参与者采集指尖血样进行 CarestartTM pf/pan RDT 测试、显微镜检查和干血斑（DBS）分析以及 18S 巢式 PCR 检测。使用 STATA11 分析数据，计算敏感性、特异性、预测值和准确性。

结果

在 128 例无症状患者中，26 例（20.3%）18S 巢式 PCR 检测疟原虫阳性，5 例（3.9%）RDT 检测阳性，8 例（6.3%）显微镜检查阳性。在 202 例有症状患者中，55 例（27.23%）、26 例（12.87%）和 28 例（13.86%）分别对 18S 巢式 PCR、RDT 和显微镜检查呈阳性。18S 巢式 PCR、显微镜检查和 CarestartTMpf/pan RDT 的比较分析显示，诊断有症状疟疾感染的敏感性均为 50%，特异性均为 100%。此外，种系水平分析显示，18S 巢式 PCR 的检测率为 26（20.31%），高于显微镜检查的 8（6.25%）和 CareStartTM pf/pan RDT 的 5（4.1%）。CarestartTMpf/pan RDT 检测无症状疟疾感染的敏感性为 15.4%，特异性为 98%。然而，这两种方法的敏感性相当。