Multicenter Evaluation of the BioFire FilmArray Gastrointestinal Panel for Etiologic Diagnosis of Infectious Gastroenteritis

Abstract

fThe appropriate treatment and control of infectious gastroenteritis depend on the ability to rapidly detect the wide range of etiologic agents associated with the disease. Clinical laboratories currently utilize an array of different methodologies to test for bacterial, parasitic, and viral causes of gastroenteritis, a strategy that suffers from poor sensitivity, potentially long turnaround times, and complicated ordering practices and workflows. Additionally, there are limited or no testing methods routinely available for most diarrheagenic Escherichia coli strains, astroviruses, and sapoviruses. This study assessed the performance of the FilmArray Gastrointestinal (GI) Panel for the simultaneous detection of 22 different enteric pathogens directly from stool specimens: Campylobacter spp., Clostridium difficile (toxin A/B), Plesiomonas shigelloides, Salmonella spp., Vibrio spp., Vibrio cholerae, Yersinia enterocolitica, enteroaggregative E. coli, enteropathogenic E. coli, enterotoxigenic E. coli, Shiga-like toxin-producing E. coli (stx 1 and stx 2 ) (including specific detection of E. coli O157), Shigella spp./enteroinvasive E. coli, Cryptosporidium spp., Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, adenovirus F 40/41, astrovirus, norovirus GI/GII, rotavirus A, and sapovirus. Prospectively collected stool specimens (n ‫؍‬ 1,556) were evaluated using the BioFire FilmArray GI Panel and tested with conventional stool culture and molecular methods for comparison. The FilmArray GI Panel sensitivity was 100% for 12/22 targets and >94.5% for an additional 7/22 targets. For the remaining three targets, sensitivity could not be calculated due to the low prevalences in this study. The FilmArray GI Panel specificity was >97.1% for all panel targets. The FilmArray GI Panel provides a comprehensive, rapid, and streamlined alternative to conventional methods for the etiologic diagnosis of infectious gastroenteritis in the laboratory setting. The potential advantages include improved performance parameters, a more extensive menu of pathogens, and a turnaround time of as short as 1 h. Infectious gastroenteritis (IGE) is a leading cause of global morbidity and mortality. It is estimated that IGE contributes to the death of 2,195 children each day (1). IGE also contributes to serious morbidities, such as malnutrition, stunting, and impaired cognitive function (2, 3). Diarrheal disease disproportionately affects developing nations, but IGE remains a significant problem in industrialized countries as well. For example, it is estimated that each year, approximately 178.8 million cases of gastrointestinal illness occur in the United States, resulting in 474,000 hospitalizations and 5,000 deaths (4). Although the etiologic agents responsible for about 80% of these illnesses are unidentified or otherwise unspecified (4), norovirus and Salmonella spp. are currently the most commonly identified pathogens associated with food-borne disease in the United States and account for 5.5 and 1.0 million cases each year, resp...

Panel Filmarray GI® en la detección de patógenos entéricos en deposiciones: experiencia preliminar

“…Estudios recientes, encontraron que 32,9%, 54,2% y 31,5% de las muestras positivas por Filmarray presentaban más de un patógeno [7][8][9][10] . Una explicación a estos hallazgos puede asociarse a la falta de experiencia clínica en exámenes que detectan un número importante de patógenos en una misma reacción.…”

“…Desde su descubrimiento, el diagnóstico de estos patógenos se basa en la detección de genes de patogenicidad específicos para cada serotipo mediante técnicas de biología molecular, una situación que impide determinar la prevalencia de estos patotipos y su uso como una técnica de rutina 10 . Tal como se presenta en la tabla 1, de las 354 detecciones positivas en 137 (38,7%) se detectaron E. coli diarreogénicas, en su mayoría asociado a co-infecciones (≥ 70%), con alto número de detecciones positivas para los patotipos EPEC y EAEC, consistentes con reportes previos [7][8][9] . Será interesante implementar en el futuro estudios epidemiológicos destinados a establecer la prevalencia de estos patógenos de modo de diseñar estrategias que permitan su manejo y control.…”

“…Además, esta técnica requiere de un tiempo de operador de alrededor de cinco minutos y no requiere análisis posteriores, obteniendo los resultados en una hora 7 .…”

Is Follow-Up Testing with the FilmArray Gastrointestinal Multiplex PCR Panel Necessary?

“…he FilmArray gastrointestinal (GI) panel (BioFire Diagnostics, Salt Lake City, UT) is a novel sample-to-answer, on-demand, multiplex, real-time PCR assay for the syndromic diagnosis of infectious gastroenteritis (1). The FilmArray GI panel has been adopted by many academic and community hospitals in the United States.…”

Challenges in fecal donor selection and screening for fecal microbiota transplantation: A review

“…37 Similarly, PCR-based multiplex panels that have been developed for rapid identification of other bacterial, viral and parasitic pathogens in infectious diarrhea have been developed compared with culture of loose/watery stool specimens. 42 While most donor screening recommendations suggest stool culture, antigen testing and microscopic examination for ova and parasites as a means of screening for asymptomatic carriage, a study to validate gastrointestinal pathogen panels for asymptomatic pathogen colonization could potentially reduce costs to stool banking programs and improve efficiency of screening.…”