快速诊断检测、显微镜检查、环介导等温扩增（LAMP）和聚合酶链反应（PCR）在埃塞俄比亚疟疾诊断中的性能：系统评价和荟萃分析。
Performance of rapid diagnostic tests, microscopy, loop-mediated isothermal amplification (LAMP) and PCR for malaria diagnosis in Ethiopia: a systematic review and meta-analysis.
机构信息
Department of Microbiology, Immunology and Parasitology, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Ethiopian Public Health Institute, Addis Ababa, Ethiopia.
出版信息
Malar J. 2021 Sep 27;20(1):384. doi: 10.1186/s12936-021-03923-8.
BACKGROUND
Rapid accurate diagnosis followed by effective treatment is very important for malaria control. Light microscopy remains the "golden standard" method for malaria diagnosis. Diagnostic test method must have sufficient level of accuracy for detecting malaria parasites. Therefore, this study aimed to investigate the diagnostic accuracy of rapid diagnostic tests (RDTs), microscopy, loop-mediated isothermal amplification (LAMP) and/or polymerase chain reaction (PCR) for the malaria diagnosis in Ethiopia.
METHODS
Data bases such as PubMed, PubMed central, Science direct databases, Google scholar, and Scopus were searched from September to October, 2020 for studies assessing the diagnostic accuracy of RDTs, microscopy, LAMP and PCR methods for malaria diagnosis.
RESULTS
A total of 29 studies published between 2001 and 2020 were analysed using review manager, Midas (Stata) and Meta-disc. The sensitivity and specificity of studies comparing RDT with microscopy varies from 79%-100% to 80%-100%, respectively. The sensitivity of LAMP (731 tests) was 100% and its specificity was varies from 85 to 99% when compared with microscopy and PCR. Considerable heterogeneity was observed between studies included in this meta-analysis. Meta-regression showed that blinding status and target antigens were the major sources of heterogeneity (P < 0.05). RDT had an excellent diagnostic accuracy (Area under the ROC Curve = 0.99) when compared with microscopy. Its specificity was quite good (93%-100%) except for one outlier (28%), but lower "sensitivity" was observed when PCR is a reference test. This indicates RDT had a good diagnostic accuracy (AUC = 0.83). Microscopy showed a very good diagnostic accuracy when compared with PCR.
CONCLUSIONS
The present study showed that microscopy and RDTs had high efficiency for diagnosing febrile malaria patients. The diagnostic accuracy of RDT was excellent when compared with microscopy. This indicates RDTs have acceptable sensitivities and specificities to be used in resource poor settings as an alternative for microscopy. In this study, LAMP showed an excellent sensitivities and specificities. Furthermore, the need of minimum equipment and relatively short time for obtaining results can made LAMP one of the best alternatives especially for accurate diagnosis of asymptomatic malaria.
背景
快速准确的诊断后进行有效的治疗对疟疾控制非常重要。 显微镜检查仍然是疟疾诊断的“金标准”方法。诊断测试方法必须具有足够的检测疟疾寄生虫的准确性。因此，本研究旨在探讨在埃塞俄比亚快速诊断检测（RDT）、显微镜检查、环介导等温扩增（LAMP）和/或聚合酶链反应（PCR）检测疟疾的诊断准确性。
方法
2020 年 9 月至 10 月，我们在 PubMed、PubMed Central、Science Direct 数据库、Google Scholar 和 Scopus 数据库中搜索了评估 RDT、显微镜检查、LAMP 和 PCR 方法诊断疟疾的诊断准确性的研究。
结果
共分析了 2001 年至 2020 年期间发表的 29 项研究，使用 Review Manager、Midas（Stata）和 Meta-disc 进行分析。比较 RDT 与显微镜检查的研究的灵敏度和特异性分别为 79%-100%至 80%-100%。与显微镜检查和 PCR 相比，LAMP（731 次检测）的灵敏度为 100%，特异性为 85%-99%。Meta 分析中纳入的研究存在显著异质性。Meta 回归显示，盲法状态和靶抗原是异质性的主要来源（P<0.05）。与显微镜检查相比，RDT 具有优异的诊断准确性（ROC 曲线下面积=0.99）。当 PCR 作为参考测试时，其特异性相当好（93%-100%），除了一个异常值（28%）外，但其灵敏度较低。这表明 RDT 具有良好的诊断准确性（AUC=0.83）。与 PCR 相比，显微镜检查具有很高的诊断准确性。
结论
本研究表明，显微镜检查和 RDT 对诊断发热性疟疾患者具有高效性。与显微镜检查相比，RDT 的诊断准确性很高。这表明 RDT 具有可接受的敏感性和特异性，可作为资源匮乏地区替代显微镜检查的方法。在这项研究中，LAMP 表现出了极好的敏感性和特异性。此外，它需要的设备最少，获得结果的时间相对较短，这使其成为一个特别好的选择，特别是用于准确诊断无症状疟疾。
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