两种疟疾快速诊断检测方法与实时聚合酶链反应及显微镜检测金标准方法的性能比较

Performance comparison of two malaria rapid diagnostic test with real time polymerase chain reaction and gold standard of microscopy detection method.

作者信息

Wardhani Puspa, Butarbutar Trieva Verawaty, Adiatmaja Christophorus Oetama, Betaubun Amarensi Milka, Hamidah Nur

机构信息

Clinical Pathology Department.

Dr. Soetomo General Academic Hospital, Surabaya, Indonesia.

出版信息

Infect Dis Rep. 2020 Jul 6;12(Suppl 1):8731. doi: 10.4081/idr.2020.8731. eCollection 2020 Jul 7.

DOI:10.4081/idr.2020.8731

PMID:32874462

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7447940/

Abstract

BACKGROUND

The diagnostic test for malaria is mostly based on Rapid Diagnostic Test (RDT) and detection by microscopy. Polymerase Chain Reaction (PCR) is also a sensitive detection method that can be considered as a diagnostic tool. The outcome of malaria microscopy detection depends on the examiner's ability and experience. Some RDT has been distributed in Indonesia, which needs to be evaluated for their results.

OBJECTIVE

This study aimed to compare the performance of RightSign RDT and ScreenPlus RDT for detection of in human blood. We used specific real-time polymerase chain reaction abTESTMMalaria qPCRII) and gold standard of microscopy detection method to measure diagnostic efficiency.

METHODS

Blood specimens were evaluated using RightSign RDT, ScreenPlus RDT, Microscopy detection, and RT-PCR as the protocol described. The differences on specificity (Sp), sensitivity (Sn), positive predictive value (PPV), and negative predictive value (NPV) were analyzed using McNemar and Kruskal Wallis analysis.

RESULTS

A total of 105 subjects were recruited. Based on microscopy test, RightSign RDT had sensitivity, Specificity, PPV, NPV, 100%, 98%, 98.2%, 100%, respectively. ScreenPlus showed 100% sensitivity, 98% specificity, 98.2% PPV, 100% NPV. The sensitivity of both RDTs became lower (75%) and the specificity higher (100 %) when using real-time PCR. Both RDTs showed a 100% agreement. RTPCR detected higher mix infection when compared to microscopy and RDTs.

CONCLUSION

RightSign and ScreenPlus RDT have excellent performance when using microscopy detection as a gold standard. Real-time PCR method can be considered as a confirmation tool for malaria diagnosis.

摘要

背景

疟疾的诊断测试主要基于快速诊断测试（RDT）和显微镜检测。聚合酶链反应（PCR）也是一种敏感的检测方法，可被视为一种诊断工具。疟疾显微镜检测的结果取决于检查者的能力和经验。一些RDT已在印度尼西亚分发，需要对其结果进行评估。

目的

本研究旨在比较RightSign RDT和ScreenPlus RDT在检测人血中疟疾的性能。我们使用特异性实时聚合酶链反应（abTESTMMalaria qPCRII）和显微镜检测方法的金标准来测量诊断效率。

方法

按照所述方案，使用RightSign RDT、ScreenPlus RDT、显微镜检测和RT-PCR对血液标本进行评估。使用McNemar和Kruskal Wallis分析来分析特异性（Sp）、敏感性（Sn）、阳性预测值（PPV）和阴性预测值（NPV）的差异。

结果

共招募了105名受试者。基于显微镜检测，RightSign RDT的敏感性、特异性、PPV、NPV分别为100%、98%、98.2%、100%。ScreenPlus显示敏感性为100%，特异性为98%，PPV为98.2%，NPV为100%。使用实时PCR时，两种RDT的敏感性均降低（75%），特异性升高（100%）。两种RDT显示出100%的一致性。与显微镜和RDT相比，RT-PCR检测到更高的混合感染率。