{"title":"Fungal false positive in BioFire® FilmArray® analysis for bloodstream infection","authors":"Osamu Imataki , Ryoko Masumoto , Masahiro Hamano , Masaki Ishimatsu , Shin-ichiro Suemori , Takayuki Tsujioka , Masayo Tamura , Akira Kitanaka","doi":"10.1016/j.mimet.2025.107380","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>The BioFire FilmArray® system is an automated multiplex PCR tool for detecting pathogens in clinical samples. False positives occasionally occur due to cross-reactivity, contamination, or assay specificity issues. This study investigated false-positive fungal results in FilmArray® blood culture identification panel 2 (BCID2) detection system.</div></div><div><h3>Method</h3><div>We collected the continuous cases in which bloodstream infection (BSI) was suspected in our institute for 12 months, from April in 2024 to March in 2025. We routinely used Bactec FX culture system (Beckton Dickinson) with BD BACTEC culture bottles. Alongside, we identified fungus using standard culture method and matrix-assisted laser desorption ionization-time of flight mass spectrometry (biomerieux, VITEK MS PRIME).</div></div><div><h3>Results</h3><div>We evaluated continuous 454 blood culture positive sample. Average blood culture sampling were totally 5357 samples per year (44.3/1000 patients days) of blood cultures during our study period. We collected 28 cases of fungemia among totally recruited 454 samples (6.2 %, 28/454). Accordance of blood culture and FilmArray® were 50.0 % (14 samples). We observed eight false positive samples (1.8 %. 8/454) as fungemia out of total 454 samples, in where one false organism was <em>Candida albicans</em> and seven were <em>Candida tropicalis</em>. In the cases of four false <em>Candida tropicalis</em> samples, the FilmArray® reported the two fungal combination, <em>Candida parapsilosis</em> and <em>Candida tropicalis</em>.</div></div><div><h3>Conclusion</h3><div>Our investigation revealed a substantial incident of false positive of <em>Candida</em>. The study highlights recurrent false positives of <em>Candida tropicalis</em>, often detected alongside <em>Candida parapsilosis</em>. The main cause of the detection of false positive organism in BCID2 including <em>Candida</em> spp. has been reported as contamination or technical errors. We speculated that our observation could be derived from the non-viable DNA fragments (<em>Candida albicans</em>) contained in the blood culture media and cross-reaction of <em>Candida parapsilosis</em> with <em>Candida tropicalis</em>. We should remember these FilmArray® assay limitations linked to non-viable DNA contamination and high reactivity of sensitive PCR analysis. False positive results for <em>Candida</em> spp. in BCID2 assays require careful interpretation with microbiological expertise. Clinical decisions should be guided by the patient's overall context. Further research is necessary to assess the accuracy of fungal BSI. (341/500 words).</div></div>","PeriodicalId":16409,"journal":{"name":"Journal of microbiological methods","volume":"241 ","pages":"Article 107380"},"PeriodicalIF":2.5000,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of microbiological methods","FirstCategoryId":"99","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0167701225002969","RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/12/25 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
引用次数: 0
Abstract
Background
The BioFire FilmArray® system is an automated multiplex PCR tool for detecting pathogens in clinical samples. False positives occasionally occur due to cross-reactivity, contamination, or assay specificity issues. This study investigated false-positive fungal results in FilmArray® blood culture identification panel 2 (BCID2) detection system.
Method
We collected the continuous cases in which bloodstream infection (BSI) was suspected in our institute for 12 months, from April in 2024 to March in 2025. We routinely used Bactec FX culture system (Beckton Dickinson) with BD BACTEC culture bottles. Alongside, we identified fungus using standard culture method and matrix-assisted laser desorption ionization-time of flight mass spectrometry (biomerieux, VITEK MS PRIME).
Results
We evaluated continuous 454 blood culture positive sample. Average blood culture sampling were totally 5357 samples per year (44.3/1000 patients days) of blood cultures during our study period. We collected 28 cases of fungemia among totally recruited 454 samples (6.2 %, 28/454). Accordance of blood culture and FilmArray® were 50.0 % (14 samples). We observed eight false positive samples (1.8 %. 8/454) as fungemia out of total 454 samples, in where one false organism was Candida albicans and seven were Candida tropicalis. In the cases of four false Candida tropicalis samples, the FilmArray® reported the two fungal combination, Candida parapsilosis and Candida tropicalis.
Conclusion
Our investigation revealed a substantial incident of false positive of Candida. The study highlights recurrent false positives of Candida tropicalis, often detected alongside Candida parapsilosis. The main cause of the detection of false positive organism in BCID2 including Candida spp. has been reported as contamination or technical errors. We speculated that our observation could be derived from the non-viable DNA fragments (Candida albicans) contained in the blood culture media and cross-reaction of Candida parapsilosis with Candida tropicalis. We should remember these FilmArray® assay limitations linked to non-viable DNA contamination and high reactivity of sensitive PCR analysis. False positive results for Candida spp. in BCID2 assays require careful interpretation with microbiological expertise. Clinical decisions should be guided by the patient's overall context. Further research is necessary to assess the accuracy of fungal BSI. (341/500 words).
期刊介绍:
The Journal of Microbiological Methods publishes scholarly and original articles, notes and review articles. These articles must include novel and/or state-of-the-art methods, or significant improvements to existing methods. Novel and innovative applications of current methods that are validated and useful will also be published. JMM strives for scholarship, innovation and excellence. This demands scientific rigour, the best available methods and technologies, correctly replicated experiments/tests, the inclusion of proper controls, calibrations, and the correct statistical analysis. The presentation of the data must support the interpretation of the method/approach.
All aspects of microbiology are covered, except virology. These include agricultural microbiology, applied and environmental microbiology, bioassays, bioinformatics, biotechnology, biochemical microbiology, clinical microbiology, diagnostics, food monitoring and quality control microbiology, microbial genetics and genomics, geomicrobiology, microbiome methods regardless of habitat, high through-put sequencing methods and analysis, microbial pathogenesis and host responses, metabolomics, metagenomics, metaproteomics, microbial ecology and diversity, microbial physiology, microbial ultra-structure, microscopic and imaging methods, molecular microbiology, mycology, novel mathematical microbiology and modelling, parasitology, plant-microbe interactions, protein markers/profiles, proteomics, pyrosequencing, public health microbiology, radioisotopes applied to microbiology, robotics applied to microbiological methods,rumen microbiology, microbiological methods for space missions and extreme environments, sampling methods and samplers, soil and sediment microbiology, transcriptomics, veterinary microbiology, sero-diagnostics and typing/identification.