Evaluation of a point-of-care multiplex immunochromatographic assay for the diagnosis of typhoid: results from a retrospective diagnostic accuracy study.

IF 6.1 2区 医学 Q1 MICROBIOLOGY
Journal of Clinical Microbiology Pub Date : 2024-10-16 Epub Date: 2024-09-20 DOI:10.1128/jcm.00428-24
Rumina Hasan, Zahida Azizullah, Hina Shams, Sabine Dittrich, Jason R Andrews, Richelle C Charles, Javan Esfandiari, Dhammika Gunasekera, Kevin K A Tetteh, Jyotshna Sapkota
{"title":"Evaluation of a point-of-care multiplex immunochromatographic assay for the diagnosis of typhoid: results from a retrospective diagnostic accuracy study.","authors":"Rumina Hasan, Zahida Azizullah, Hina Shams, Sabine Dittrich, Jason R Andrews, Richelle C Charles, Javan Esfandiari, Dhammika Gunasekera, Kevin K A Tetteh, Jyotshna Sapkota","doi":"10.1128/jcm.00428-24","DOIUrl":null,"url":null,"abstract":"<p><p>There is a clear medical need for an accurate diagnostic test for typhoid that can be performed at point of care. Two antigens (lipopolysaccharide [LPS] and hemolysin E [HlyE]) have recently been identified that can distinguish typhoid from other bacterial infections. Here, we present the results of a diagnostic accuracy study of the Dual Path Platform (DPP) Typhoid assay (Chembio) that detects IgA to both LPS and HlyE using blood culture as the reference standard. This was a retrospective, observational, laboratory study conducted at the Aga Khan University research laboratory, Pakistan, to evaluate the sensitivity and specificity of the DPP Typhoid assay, using archived frozen serum samples collected during a previous typhoid diagnostic accuracy study (NCT04801602). The sensitivity, specificity, and accuracy (area under the receptor operating characteristics curve [AUC]) were then assessed using the manufacturer's and Youden's optimal thresholds. In total, 385 samples were included in the analysis. Using the manufacturer's thresholds, the sensitivity, specificity, and AUC were 97.8% (95% confidence interval [CI] 94.6-99.2), 65.3% (95% CI 58.5-71.6), and 81.5% (95% CI 75.5-85.3), respectively. At Youden's optimal threshold, the overall sensitivity of the DPP Typhoid assay was 89.7% and the specificity was 82.2%. In latent class modeling compared with other nine rapid diagnostic tests evaluated from the same cohort sample, the DPP Typhoid assay demonstrated the highest balanced accuracy (89.2%). The DPP Typhoid assay demonstrated a high diagnostic accuracy for typhoid fever. However, further adjustment to new thresholds is recommended to enhance its performance capabilities.</p><p><strong>Importance: </strong>Currently available diagnostic tests for typhoid have several limitations, including low sensitivity and specificity. Dual Path Platform Typhoid assay is a multiplex rapid test that detects IgA antibodies to lipopolysaccharide and hemolysin E antigen. It is considered to have high sensitivity and specificity, and its results were found to be highly correlated with ELISA results. However, very few studies have been conducted to evaluate this test and limited information about the accuracy of this test is present. Hence, this study evaluated the new typhoid test.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0042824"},"PeriodicalIF":6.1000,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481547/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Microbiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1128/jcm.00428-24","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/20 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MICROBIOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

There is a clear medical need for an accurate diagnostic test for typhoid that can be performed at point of care. Two antigens (lipopolysaccharide [LPS] and hemolysin E [HlyE]) have recently been identified that can distinguish typhoid from other bacterial infections. Here, we present the results of a diagnostic accuracy study of the Dual Path Platform (DPP) Typhoid assay (Chembio) that detects IgA to both LPS and HlyE using blood culture as the reference standard. This was a retrospective, observational, laboratory study conducted at the Aga Khan University research laboratory, Pakistan, to evaluate the sensitivity and specificity of the DPP Typhoid assay, using archived frozen serum samples collected during a previous typhoid diagnostic accuracy study (NCT04801602). The sensitivity, specificity, and accuracy (area under the receptor operating characteristics curve [AUC]) were then assessed using the manufacturer's and Youden's optimal thresholds. In total, 385 samples were included in the analysis. Using the manufacturer's thresholds, the sensitivity, specificity, and AUC were 97.8% (95% confidence interval [CI] 94.6-99.2), 65.3% (95% CI 58.5-71.6), and 81.5% (95% CI 75.5-85.3), respectively. At Youden's optimal threshold, the overall sensitivity of the DPP Typhoid assay was 89.7% and the specificity was 82.2%. In latent class modeling compared with other nine rapid diagnostic tests evaluated from the same cohort sample, the DPP Typhoid assay demonstrated the highest balanced accuracy (89.2%). The DPP Typhoid assay demonstrated a high diagnostic accuracy for typhoid fever. However, further adjustment to new thresholds is recommended to enhance its performance capabilities.

Importance: Currently available diagnostic tests for typhoid have several limitations, including low sensitivity and specificity. Dual Path Platform Typhoid assay is a multiplex rapid test that detects IgA antibodies to lipopolysaccharide and hemolysin E antigen. It is considered to have high sensitivity and specificity, and its results were found to be highly correlated with ELISA results. However, very few studies have been conducted to evaluate this test and limited information about the accuracy of this test is present. Hence, this study evaluated the new typhoid test.

评估用于伤寒诊断的护理点多重免疫层析测定:一项回顾性诊断准确性研究的结果。
医学界显然需要一种可在医疗点进行的伤寒准确诊断检测。最近发现的两种抗原(脂多糖 [LPS] 和溶血素 E [HlyE])可将伤寒与其他细菌感染区分开来。在此,我们介绍了以血液培养为参考标准的双路径平台(DPP)伤寒检测法(Chembio)的诊断准确性研究结果,该检测法可同时检测 LPS 和 HlyE 的 IgA。这是一项回顾性、观察性实验室研究,在巴基斯坦阿迦汗大学研究实验室进行,目的是利用之前伤寒诊断准确性研究(NCT04801602)中收集的存档冷冻血清样本,评估DPP伤寒检测法的灵敏度和特异性。然后使用制造商和尤登的最佳阈值评估灵敏度、特异性和准确性(受体工作特征曲线下面积 [AUC])。共有 385 份样本被纳入分析。使用制造商的阈值,灵敏度、特异性和 AUC 分别为 97.8%(95% 置信区间 [CI] 94.6-99.2)、65.3%(95% CI 58.5-71.6)和 81.5%(95% CI 75.5-85.3)。在尤登最佳阈值下,DPP 伤寒检测法的总体灵敏度为 89.7%,特异度为 82.2%。在潜类模型中,DPP 伤寒检测法与同组样本中的其他九种快速诊断检测法进行了比较,DPP 伤寒检测法的平衡准确率最高(89.2%)。DPP 伤寒检测法对伤寒的诊断准确率很高。然而,建议进一步调整新的阈值,以提高其性能能力:重要性:目前可用的伤寒诊断检测方法存在一些局限性,包括灵敏度和特异性较低。双路径平台伤寒检测法是一种多重快速检测法,可检测脂多糖和溶血素 E 抗原的 IgA 抗体。它被认为具有高灵敏度和特异性,其结果与 ELISA 结果高度相关。然而,很少有研究对该检测方法进行评估,有关该检测方法准确性的信息也很有限。因此,本研究对新的伤寒检验方法进行了评估。
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
Journal of Clinical Microbiology
Journal of Clinical Microbiology 医学-微生物学
CiteScore
17.10
自引率
4.30%
发文量
347
审稿时长
3 months
期刊介绍: The Journal of Clinical Microbiology® disseminates the latest research concerning the laboratory diagnosis of human and animal infections, along with the laboratory's role in epidemiology and the management of infectious diseases.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信