Clinical Performance of the LiquidArray^® Gastrointestinal VER 1.0 Assay in Patients with Suspected Gastroenteritis.

IF 3 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

Diagnostics Pub Date : 2024-10-25 DOI:10.3390/diagnostics14212377

Sophie Jones, Kathleen Pheasant, Colette Dalton, Julie Green, Catherine Moore

{"title":"Clinical Performance of the LiquidArray® Gastrointestinal VER 1.0 Assay in Patients with Suspected Gastroenteritis.","authors":"Sophie Jones, Kathleen Pheasant, Colette Dalton, Julie Green, Catherine Moore","doi":"10.3390/diagnostics14212377","DOIUrl":null,"url":null,"abstract":"Background/objectives: Rapid and accurate pathogen identification is essential for the proper management of patients with infectious gastroenteritis, as well as for a better control of disease outbreaks. This observational, non-interventional, single-site study evaluated the diagnostic accuracy of LiquidArray® Gastrointestinal VER 1.0, a multiplex PCR syndromic panel capable of detecting up to 26 clinically relevant enteropathogens.Methods: Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and likelihood ratio (LR) were evaluated using stool samples from 1512 patients with suspected gastroenteritis and were compared to seven competitor assays.Results: LiquidArray® Gastrointestinal VER 1.0 showed a very low invalid rate (0.5% at initial testing, down to 0% after repeat) and high sensitivity (>90% for most detected targets) and specificity (>99% for all detected targets). Accordingly, the PPV and NPV were high (>90% for most targets and >99% for all targets, respectively). The analytical performance of LiquidArray® Gastrointestinal VER 1.0 was also excellent as to co-amplification capability, cross-reactivity and assay precision.Conclusions: This study demonstrates the excellent clinical performance of LiquidArray® Gastrointestinal VER 1.0 and its suitability for implementation in clinical routine for the rapid and accurate diagnosis of infectious gastroenteritis.","PeriodicalId":11225,"journal":{"name":"Diagnostics","volume":"14 21","pages":""},"PeriodicalIF":3.0000,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11544872/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diagnostics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3390/diagnostics14212377","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background/objectives: Rapid and accurate pathogen identification is essential for the proper management of patients with infectious gastroenteritis, as well as for a better control of disease outbreaks. This observational, non-interventional, single-site study evaluated the diagnostic accuracy of LiquidArray^® Gastrointestinal VER 1.0, a multiplex PCR syndromic panel capable of detecting up to 26 clinically relevant enteropathogens.

Methods: Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and likelihood ratio (LR) were evaluated using stool samples from 1512 patients with suspected gastroenteritis and were compared to seven competitor assays.

Results: LiquidArray^® Gastrointestinal VER 1.0 showed a very low invalid rate (0.5% at initial testing, down to 0% after repeat) and high sensitivity (>90% for most detected targets) and specificity (>99% for all detected targets). Accordingly, the PPV and NPV were high (>90% for most targets and >99% for all targets, respectively). The analytical performance of LiquidArray^® Gastrointestinal VER 1.0 was also excellent as to co-amplification capability, cross-reactivity and assay precision.

Conclusions: This study demonstrates the excellent clinical performance of LiquidArray^® Gastrointestinal VER 1.0 and its suitability for implementation in clinical routine for the rapid and accurate diagnosis of infectious gastroenteritis.

查看原文本刊更多论文

LiquidArray® Gastrointestinal VER 1.0 检测试剂盒在疑似肠胃炎患者中的临床表现。

背景/目的：快速准确地识别病原体对于正确处理传染性肠胃炎患者以及更好地控制疾病爆发至关重要。这项观察性、非干预性、单点研究评估了 LiquidArray® Gastrointestinal VER 1.0 的诊断准确性，这是一种多重 PCR 综合样本，能够检测多达 26 种临床相关的肠道病原体：方法：使用 1512 名疑似肠胃炎患者的粪便样本对灵敏度、特异性、阳性预测值 (PPV)、阴性预测值 (NPV) 和似然比 (LR) 进行了评估，并与七种同类检测方法进行了比较：LiquidArray® Gastrointestinal VER 1.0的无效率极低（初次检测为0.5%，重复检测后降至0%），灵敏度高（大多数检测目标的灵敏度大于90%），特异性高（所有检测目标的特异性大于99%）。相应地，PPV 和 NPV 也很高（对大多数目标的检测率>90%，对所有目标的检测率>99%）。LiquidArray® Gastrointestinal VER 1.0的分析性能在共沉淀能力、交叉反应性和检测精度方面也非常出色：本研究表明，LiquidArray® Gastrointestinal VER 1.0 具有出色的临床性能，适合用于临床常规快速准确诊断传染性胃肠炎。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Diagnostics Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry

CiteScore

4.70

自引率

8.30%

发文量

2699

审稿时长

19.64 days

期刊介绍： Diagnostics (ISSN 2075-4418) is an international scholarly open access journal on medical diagnostics. It publishes original research articles, reviews, communications and short notes on the research and development of medical diagnostics. There is no restriction on the length of the papers. Our aim is to encourage scientists to publish their experimental and theoretical research in as much detail as possible. Full experimental and/or methodological details must be provided for research articles.