Percentage of culture confirmation and melting curve analysis reveals false-positive Campylobacter detection in a molecular syndromic panel.

IF 5.4 2区 医学 Q1 MICROBIOLOGY
Journal of Clinical Microbiology Pub Date : 2025-08-13 Epub Date: 2025-07-14 DOI:10.1128/jcm.00028-25
Annie Sanchez, Michael Rauch, Sherry Buechner, Brittney Jung-Hynes, Eric Beck, Allen Bateman
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引用次数: 0

Abstract

Surveillance of enteric organisms can identify outbreaks and support control measures. The BIOFIRE FilmArray Gastrointestinal Panel (FilmArray GI) is the most common culture-independent diagnostic test (CIDT) used in Wisconsin to diagnose enteric infections. State clinical laboratories have raised concerns about inaccurate Campylobacter detection with the FilmArray GI. The Wisconsin State Laboratory of Hygiene (WSLH) evaluated the percentage of positivity and culture confirmations stratified by CIDT for Campylobacter, Salmonella, and STEC from 2018 to 2024. We further analyzed the transport time of Campylobacter specimens and the melt curves of specimens that tested positive by FilmArray GI. Campylobacter, Salmonella, and STEC specimens tested on the FilmArray GI had increases in percentage of positivity compared to those tested on other CIDTs. Salmonella and STEC specimens positive by FilmArray GI, compared to other CIDTs, had no significant culture confirmation differences. However, Campylobacter specimens positive by FilmArray GI had significantly lower culture confirmations than positive specimens from other CIDTs (62% vs. 78%; P < 0.05). Campylobacter culture confirmations were lower for FilmArray GI specimens, compared to other CIDTs, regardless of how many days the specimen spent in transport in 2023. Additionally, we found atypical melt curves among specimens positive by FilmArray GI with cultures that did not grow Campylobacter. Taken together, the higher percentage of positivity, the lower percentage of culture confirmation, and the atypical melt curves suggest that the FilmArray GI might yield false-positive Campylobacter results. These findings emphasize the importance of public health surveillance to identify potential issues with commercially available diagnostic tests.IMPORTANCEEnteric pathogens cause ~9.4 million illnesses annually in the United States. Clinical laboratories rely on culture-independent diagnostic testing platforms (CIDTs) for rapid and accurate diagnosis of enteric pathogens. Campylobacter, Salmonella, and Shiga-toxin-producing Escherichia coli (STEC) are three of the most identified enteric bacterial infections in Wisconsin. The BioFire FilmArray Gastrointestinal panel (FilmArray GI) is currently the most common CIDT used by Wisconsin clinical laboratories to diagnose Campylobacter, Salmonella, and STEC infections. However, the FilmArray GI has had notable issues and recalls in the past. Here, we used public health surveillance data to assess platform performance for these organisms. We analyzed percent positivity and culture confirmations based on testing platforms. Through our analysis, we identified potential false-positive Campylobacter results from the FilmArray GI, which were associated with atypical melt curve profiles on the BioFire platform. Public health surveillance can help identify potential issues with diagnostic platforms.

百分比的培养确认和熔化曲线分析显示假阳性弯曲杆菌检测在分子综合征面板。
对肠道生物的监测可以确定疫情并支持控制措施。BIOFIRE FilmArray胃肠道测试(FilmArray GI)是威斯康星州最常用的非培养诊断测试(CIDT),用于诊断肠道感染。国家临床实验室对使用FilmArray GI检测不准确的弯曲杆菌提出了担忧。威斯康星州卫生实验室(WSLH)评估了2018年至2024年弯曲杆菌、沙门氏菌和产肠毒素大肠杆菌的CIDT分层阳性和培养确认的百分比。我们进一步分析弯曲杆菌标本的运输时间和FilmArray GI检测阳性标本的熔化曲线。在FilmArray GI上检测的弯曲杆菌、沙门氏菌和产志毒素大肠杆菌标本与在其他cidt上检测的标本相比,阳性百分比有所增加。与其他CIDTs相比,经FilmArray GI检测阳性的沙门氏菌和产志贺毒素大肠杆菌标本培养证实无显著差异。然而,FilmArray GI阳性弯曲杆菌标本的培养确证率明显低于其他cidt阳性标本(62% vs. 78%;P < 0.05)。与其他cidt相比,无论标本在2023年运输了多少天,FilmArray GI标本的弯曲杆菌培养确认率都较低。此外,我们在FilmArray GI阳性标本中发现了非典型的熔化曲线,培养物中没有生长弯曲杆菌。综上所述,较高的阳性百分比,较低的培养确认百分比,以及非典型的熔融曲线表明FilmArray GI可能产生假阳性弯曲杆菌结果。这些发现强调了公共卫生监测的重要性,以识别商用诊断测试的潜在问题。在美国,肠道病原体每年导致约940万人患病。临床实验室依靠非培养诊断测试平台(CIDTs)快速准确地诊断肠道病原体。弯曲杆菌、沙门氏菌和产志贺毒素大肠杆菌(STEC)是威斯康辛州最常见的三种肠道细菌感染。BioFire FilmArray胃肠道面板(FilmArray GI)是目前威斯康星州临床实验室诊断弯曲杆菌、沙门氏菌和产肠毒素大肠杆菌感染最常用的CIDT。然而,FilmArray GI在过去也有过明显的问题和召回。在这里,我们使用公共卫生监测数据来评估这些生物的平台性能。我们分析了基于测试平台的阳性百分比和培养确认。通过我们的分析,我们从FilmArray GI中发现了潜在的假阳性弯曲杆菌,这与BioFire平台上的非典型熔融曲线曲线相关。公共卫生监测有助于识别诊断平台的潜在问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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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.
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