Sanchez Annie, Rauch Michael, Buechner Sherry, Jung-Hynes Brittney, Beck Eric, Bateman Allen
Laboratory Leadership Service, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Communicable Disease Division, Wisconsin State Laboratory of Hygiene, Madison, Wisconsin, USA.
J Clin Microbiol. 2025 Aug 13;63(8):e0002825. doi: 10.1128/jcm.00028-25. Epub 2025 Jul 14.
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 detection with the FilmArray GI. The Wisconsin State Laboratory of Hygiene (WSLH) evaluated the percentage of positivity and culture confirmations stratified by CIDT for , , and STEC from 2018 to 2024. We further analyzed the transport time of specimens and the melt curves of specimens that tested positive by FilmArray GI. , , and STEC specimens tested on the FilmArray GI had increases in percentage of positivity compared to those tested on other CIDTs. and STEC specimens positive by FilmArray GI, compared to other CIDTs, had no significant culture confirmation differences. However, specimens positive by FilmArray GI had significantly lower culture confirmations than positive specimens from other CIDTs (62% vs. 78%; < 0.05). ulture 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 . 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 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. , , and Shiga-toxin-producing (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 , , 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 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.
对肠道微生物的监测可以识别疫情并支持控制措施。BIOFIRE FilmArray胃肠检测板（FilmArray GI）是威斯康星州用于诊断肠道感染的最常见的非培养诊断测试（CIDT）。州临床实验室对FilmArray GI检测结果的准确性表示担忧。威斯康星州卫生实验室（WSLH）评估了2018年至2024年期间按CIDT分层的、和产志贺毒素大肠杆菌（STEC）的阳性率和培养确认率。我们进一步分析了标本的运输时间以及FilmArray GI检测呈阳性的标本的熔解曲线。与在其他CIDT上检测的标本相比，在FilmArray GI上检测的、和STEC标本的阳性率有所增加。与其他CIDT相比，FilmArray GI检测呈阳性的和STEC标本在培养确认方面没有显著差异。然而，FilmArray GI检测呈阳性的标本的培养确认率明显低于其他CIDT检测呈阳性的标本（62%对78%；<0.05）。与其他CIDT相比，无论标本在2023年运输了多少天，FilmArray GI标本的培养确认率都较低。此外，我们在FilmArray GI检测呈阳性且培养未生长的标本中发现了非典型熔解曲线。综上所述，较高的阳性率、较低的培养确认率和非典型熔解曲线表明FilmArray GI可能产生假阳性结果。这些发现强调了公共卫生监测对于识别商用诊断测试潜在问题的重要性。重要性在美国，肠道病原体每年导致约940万例疾病。临床实验室依靠非培养诊断测试平台（CIDT）快速准确地诊断肠道病原体。、和产志贺毒素大肠杆菌（STEC）是威斯康星州最常被识别出的三种肠道细菌感染。BioFire FilmArray胃肠检测板（FilmArray GI）是目前威斯康星州临床实验室用于诊断、和STEC感染的最常见的CIDT。然而，FilmArray GI过去曾出现过显著问题并被召回。在此，我们使用公共卫生监测数据来评估该平台对这些微生物的性能。我们根据检测平台分析了阳性率和培养确认率。通过我们的分析，我们识别出FilmArray GI可能存在的假阳性结果，这些结果与BioFire平台上的非典型熔解曲线特征有关。公共卫生监测有助于识别诊断平台的潜在问题。
