BacteriologyPerformance of the Verigene® enteric pathogens test, Biofire FilmArray™ gastrointestinal panel and Luminex xTAG® gastrointestinal pathogen panel for detection of common enteric pathogens☆
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
References (18)
- et al.
A cost benefit analysis of the Luminex xTAG gastrointestinal pathogen panel for detection of infectious gastroenteritis in hospitalised patients
J Infect
(2015) - et al.
Multiplex molecular testing for management of infectious gastroenteritis in a hospital setting: a comparative diagnostic and clinical utility study
Clin Microbiol Infect
(2014) - et al.
Value of stool cultures
Lancet
(1980) - et al.
Development and assessment of molecular diagnostic tests for 15 enteropathogens causing childhood diarrhoea: a multicentre study
Lancet Infect Dis
(2014) - et al.
Simultaneous detection of gastrointestinal pathogens with a multiplex Luminex-based molecular assay in stool samples from diarrhoeic patients
Clin Microbiol Infect
(2013) - et al.
Added value of multiplex Luminex gastrointestinal pathogen panel (xTAG GPP) testing in the diagnosis of infectious gastroenteritis
Clin Microbiol Infect
(2014) - et al.
Multiplex polymerase chain reaction tests for detection of pathogens associated with gastroenteritis
Clin Lab Med
(2015) - et al.
Gastrointestinal pathogens detected by multiplex nucleic acid amplification testing in stools of pediatric patients and patients returning from the tropics
Infection
(2014)
Cited by (84)
Exploring the Utility of Multiplex Infectious Disease Panel Testing for Diagnosis of Infection in Different Body Sites: A Joint Report of the Association for Molecular Pathology, American Society for Microbiology, Infectious Diseases Society of America, and Pan American Society for Clinical Virology
2023, Journal of Molecular DiagnosticsGenomic analysis of microbial infections
2023, Molecular Medical Microbiology, Third EditionMolecular diagnosis of Toxoplasma gondii
2023, Molecular Medical Microbiology, Third EditionSyndromic and Point-of-Care Molecular Testing
2022, Clinics in Laboratory MedicineCitation Excerpt :The NxTAG next-generation Respiratory Pathogen Panel allows users to selectively report analytes (see Table 2) whereas the xTAG Gastrointestinal Pathogen Panel (see Table 3) does not. See refs. 36–38 for performance characteristics. Accurate diagnosis and early, appropriate treatment of sepsis is a life-saving event.
Comprehensive review of conventional and state-of-the-art detection methods of Cryptosporidium
2022, Journal of Hazardous Materials
- ☆
Conflict of Interest: None.