Bacteriology
Performance of the Verigene® enteric pathogens test, Biofire FilmArray™ gastrointestinal panel and Luminex xTAG® gastrointestinal pathogen panel for detection of common enteric pathogens

https://doi.org/10.1016/j.diagmicrobio.2016.09.013Get rights and content

Abstract

Background

Multiplex syndromic panels have the capability of identifying causes of diarrheal illness. This study evaluated the performance characteristics of three multiplex molecular assays for the detection of common stool pathogens.

Methods

A total of 152 stool specimens were tested using three platforms: Verigene Enteric Pathogens Test (Verigene), Biofire FilmArray Gastrointestinal Panel (Biofire) and Luminex xTAG® Gastrointestinal Pathogen Panel (Luminex). Assays were assessed only for the targets common among all three; namely, Campylobacter, Salmonella, Shigella, Shiga toxin-producing E. coli (STEC), norovirus, and rotavirus.

Results

The sensitivities (%) and specificities (%) of the assays were: Campylobacter, Biofire (100,100), Verigene (83.3,99.3), Luminex (91.7,100); Salmonella, Biofire (95.8,100), Verigene (83.3,100), Luminex (79.2,100); Shigella, Biofire (100,100), Verigene (95.4,99.1), Luminex (100,100); STEC, Biofire (100,100), Verigene (91.7,100), Luminex (91.7,100); norovirus, Biofire (94.7,99.3), Verigene (89.0,100), Luminex (89.5,100); and rotavirus, Biofire (100, 98.6), Verigene (71.4,100), Luminex (100,100).

Conclusions

All multiplex panels detected the majority of gastrointestinal pathogens when compared to conventional methods.

Introduction

Annually, 2 billion new cases of gastroenteritis occur worldwide resulting in the death of 1.9 million children <5 years of age (Farthing et al., 2013). Gastroenteritis can be caused by bacterial, viral, & parasitic infections; and it is usually transmitted by improperly prepared foods, contaminated water, or close contact with infectious individuals (Guerrant et al., 2001). The mainstay of treatment for gastroenteritis is oral/intravenous rehydration. However, antimicrobials may be used in severe cases of gastroenteritis caused by certain pathogens. Timely and accurate identification of stool pathogens is essential in the management of these patients. Additionally, rapid identification of stool pathogens is important for local infection control decisions. The gold standard for identification of many common bacterial stool pathogens is the stool culture, which can require up to 48 to 72 hours to complete, is not cost effective and generally has a low yield of recovery (Koplan et al., 1980, Morris et al., 1996, Siegel et al., 1990). Conventional methods for identification of enteric viral pathogens, such as enzyme linked immunosorbent assay (EIA)-based antigen detection, lack sensitivity while methods for stool parasite detection are labor intensive and require highly trained personnel.

Recently, several rapid multiplex Food and Drug Administration (FDA)-cleared molecular assays have become available for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and/or parasites. These include the Verigene® Enteric Pathogens Test (Nanosphere, Inc., Northbrook, IL), Biofire FilmArray™ Gastrointestinal Panel (BioFire Diagnostics, Salt Lake City, UT) and Luminex xTAG® Gastrointestinal Pathogen Panel (Luminex Corporation, Toronto, Canada). All three panels are performed on different platforms and test for a number of different gastrointestinal (GI) pathogens. However, they are similar in that they are all based on multiplex PCR technologies and have significantly faster turnaround time when compared to the typical turnaround time of 2 to 3 days or longer for stool culture. This study compared the performance characteristics of these three FDA-cleared molecular assays for common enteric pathogens including Campylobacter, Salmonella, Shigella, shiga toxin-producing E. coli, norovirus, and rotavirus.

Section snippets

Patient samples

A total of 152 stool specimens were procured: 98 retrospective and 54 prospective samples collected from pediatric patients with signs and symptoms of acute gastroenteritis. The 98 retrospective stool samples were collected from May 2013 through January 2014 and stored in Cary Blair at −70 °C until testing of the GI panels commenced in August 2015. All retrospective samples were positive for a stool pathogen detected by traditional culture or EIA and were included in the study to validate the

Results

The Biofire gastrointestinal panel showed a sensitivity of 100% for detection of Campylobacter (12/12), Shigella (43/43), Shiga toxin (12/12), and rotavirus (7/7), 95.8% sensitivity for detection of Salmonella (23/24), and 94.7% sensitivity for detection of norovirus (18/19). The Luminex GPP was 100% sensitive for detection of both Shigella (43/43) and rotavirus (7/7), while the sensitivity for other targets ranged from 79.2% for Salmonella (19/24) to 91.7% for detection of Shiga toxin (11/12).

Discussion

Recent technical advances in the clinical laboratory have included the use of highly multiplexed molecular assays for detection and identification of pathogens responsible for causing a myriad of infections. These panels have been designed and constructed to include the common etiologic agents (bacterial, viral, and/or parasitic) purported to cause gastroenteritis, respiratory infections, bacteremia, or meningoencephalitis (Zhang et al., 2015). We compared the performance of three multiplexed

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Conflict of Interest: None.

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