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五种分子检测方法对登革热病毒检测的诊断准确性。

Diagnostic Accuracy of Five Molecular Assays for the Detection of Dengue Virus.

机构信息

Department of Health Sciences, University of Genoa, 16132 Genoa, Italy.

Hygiene Unit, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.

出版信息

Medicina (Kaunas). 2024 Sep 23;60(9):1557. doi: 10.3390/medicina60091557.

Abstract

: The steady spread of dengue virus (DENV) poses a profound public health threat worldwide. Reverse transcription real-time polymerase chain reaction (RT2-PCR) has been increasingly recognized as a reference method for the diagnosis of acute dengue infection. The goal of this study was to assess the diagnostic accuracy of five different RT2-PCR kits for the detection of DENV in a historically processed set of sera samples. : In this retrospective study, 25 sera samples from routinely processed unique adult patients with a known DENV status (previously tested in both molecular and serological assays) were tested in parallel using four conventional (RealStar Dengue PCR Kit 3.0, Clonit'ngo Zika, Dengue & Chikungunya, BioPerfectus Zika Virus/Dengue Virus/Chikungunya Virus Real Time PCR Kit and Novaplex Tropical fever virus) and one sample-to-result (STANDARD M10 Arbovirus Panel) RT2-PCR assays. Additionally, an end-point dilution analysis was conducted in quintuplicate on six serial dilutions of an RNA preparation obtained from a culture-grown DENV serotype 1 strain for a total of 150 tests. : The overall accuracy of the evaluated tests ranged from 84% to 100%. In particular, the sensitivity of three conventional RT2-PCR assays (RealStar, Clonit'ngo and Novaplex) was 100% (95% CI: 79.6-100%), while it was lower (73.3%; 95% CI: 48.1-89.1%) for the BioPerfectus kit. The sample-to-result STANDARD M10 panel performed comparatively well, showing a sensitivity of 92.9% (95% CI: 68.5-98.7%). No false positive results were registered in any assay. The end-point dilution analysis suggested that the RealStar kit had the lowest limit of detection. : Available RT2-PCR kits for the detection of DENV are highly specific and generally sensitive and, therefore, their implementation in diagnostic pathways is advisable.

摘要

登革热病毒(DENV)的稳定传播对全球公共卫生构成了严重威胁。逆转录实时聚合酶链反应(RT2-PCR)已越来越被认为是诊断急性登革热感染的参考方法。本研究旨在评估五种不同 RT2-PCR 试剂盒在一组历史处理血清样本中检测 DENV 的诊断准确性。

在这项回顾性研究中,使用四种常规 RT2-PCR 试剂盒(RealStar Dengue PCR Kit 3.0、Clonit'ngo Zika、Dengue & Chikungunya、BioPerfectus Zika Virus/Dengue Virus/Chikungunya Virus Real Time PCR Kit)和一种样本到结果(STANDARD M10 Arbovirus Panel)对 25 份来自常规处理的具有已知 DENV 状态的独特成年患者的血清样本进行了平行检测。此前已在分子和血清学检测中进行了检测)。此外,还对从培养的 DENV 血清型 1 株获得的 RNA 制剂的六个连续稀释度进行了终点稀释分析,共进行了 150 次测试。

评估测试的整体准确性范围为 84%至 100%。特别是,三种常规 RT2-PCR 检测(RealStar、Clonit'ngo 和 Novaplex)的灵敏度为 100%(95%CI:79.6-100%),而 BioPerfectus 试剂盒的灵敏度较低(73.3%;95%CI:48.1-89.1%)。样本到结果的 STANDARD M10 面板表现相对较好,灵敏度为 92.9%(95%CI:68.5-98.7%)。任何检测均未出现假阳性结果。终点稀释分析表明,RealStar 试剂盒的检测下限最低。

用于检测 DENV 的可用 RT2-PCR 试剂盒具有高度特异性,通常具有较高的灵敏度,因此建议将其纳入诊断途径。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f5c/11434457/cf27dfdbede0/medicina-60-01557-g001.jpg

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