Investigation of suspected false positive norovirus results on a syndromic gastrointestinal multiplex molecular panel

IF 4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2024-09-30 DOI:10.1016/j.jcv.2024.105732

Mélissa Caza , Kevin Kuchinski , Kerstin Locher , Jonathan Gubbay , Matisse Harms , David M. Goldfarb , Rachel Floyd , Ethan Kenmuir , Marzieh Kalhor , Marthe Charles , Natalie Prystajecky , Amanda Wilmer

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引用次数: 0

Abstract

Background

Suspected false positive norovirus results occurred after introduction of the BioFire® FilmArray® Gastrointestinal panel (BF-GIP) into 6 laboratory sites, in British Columbia, Canada.

Objectives

The primary objective was to investigate suspected false positive results by performing additional molecular assays and whole genome sequencing (WGS). The second objective was to determine if melting curve review could predict false positive results.

Study design

From February 2023 to May 2024, the proportion of potential false positive norovirus results from the BF-GIP was calculated based on confirmatory testing using alternate molecular method. A subset of 65 norovirus BF-GIP positive specimens, including 35 negatives and 30 positives on additional molecular assays, underwent WGS. Melting curves appearances from 150 specimens were reviewed.

Results

Overall, 215/784 (27.4 %) BF-GIP norovirus results were suspected to be false positives. When using WGS, 64/65 results were in agreement with confirmatory testing. Notably, 35 specimens negative on confirmatory testing and suspected to be BF-GIP norovirus false positive results were undetectable by WGS. Melting curves did not accurately predict false positives, since 20/72 (27.8 %) had typical appearances upon review.

Conclusions

BF-GIP produces false positive results for norovirus, which cannot be predicted by melting curve review.

查看原文本刊更多论文

对综合症胃肠道多重分子检测中诺如病毒假阳性结果的调查。

背景：加拿大不列颠哥伦比亚省的 6 家实验室在引入 BioFire® FilmArray® Gastrointestinal panel (BF-GIP) 后出现了诺如病毒假阳性结果：在加拿大不列颠哥伦比亚省的 6 个实验室引入 BioFire® FilmArray® Gastrointestinal panel (BF-GIP) 后，出现了诺如病毒假阳性结果：主要目的是通过执行额外的分子检测和全基因组测序 (WGS) 来调查疑似假阳性结果。第二个目标是确定熔解曲线审查能否预测假阳性结果：研究设计：从 2023 年 2 月到 2024 年 5 月，根据使用替代分子方法进行的确证检测结果，计算出 BF-GIP 可能出现的诺如病毒假阳性结果的比例。对 65 份诺如病毒 BF-GIP 阳性标本进行了 WGS 检测，其中包括 35 份阴性标本和 30 份经其他分子检测呈阳性的标本。对 150 份标本的熔解曲线进行了审查：总的来说，215/784（27.4%）个 BF-GIP 诺如病毒结果被怀疑为假阳性。在使用 WGS 时，64/65 的结果与确证检验结果一致。值得注意的是，35 份在确证检验中呈阴性、疑似 BF-GIP 诺如病毒假阳性结果的标本在 WGS 中检测不到。熔解曲线并不能准确预测假阳性，因为有 20/72 个样本（27.8%）在复查时出现了典型的外观：结论：BF-GIP 会产生诺如病毒假阳性结果，而熔解曲线检测无法预测假阳性结果。

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 Virology 医学-病毒学

CiteScore

22.70

自引率

1.10%

发文量

149

审稿时长

24 days

期刊介绍： The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)