Gastrointestinal pathogens detected by multiplex nucleic acid amplification testing in stools of pediatric patients and patients returning from the tropics

Beckmann, Christiane; Heininger, Ulrich; Marti, Hanspeter; Hirsch, Hans H.

doi:10.1007/s15010-014-0656-7

Cited by 51 publications

(34 citation statements)

References 39 publications

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“…In addition, the xTag GPP assay identified coinfections in 9.5% (n ϭ 86) of positive samples, with C. difficile, norovirus, and Campylobacter being present in Ͼ25% of samples that had 2 or more pathogens detected (12). These data are similar to other studies that have evaluated the performance of the Luminex xTag GPP assay, which have also demonstrated that the Luminex GI panel increases both the positivity rate and the number of coinfections detected compared to conventional methods (13)(14)(15).…”

Section: How Do Multiplex Molecular Tests Perform Compared To Conventsupporting

confidence: 84%

Multiplex Molecular Panels for Diagnosis of Gastrointestinal Infection: Performance, Result Interpretation, and Cost-Effectiveness

2015

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Gastrointestinal disease is a major cause of morbidity and mortality worldwide, especially among young children and immunocompromised patients. Diarrhea may result from infection with a variety of microbial pathogens, including bacteria, viruses, or parasites. Historically, the diagnosis of infectious diarrhea has been made using microscopy, antigen tests, culture, and real-time PCR. A combination of these traditional tests is often required due to the inability to distinguish between infectious etiologies based on the clinical presentation alone. Recently, several multiplex molecular assays have been developed for the detection of gastrointestinal pathogens directly from clinical stool samples. These panels allow for the detection and identification of up to 20 pathogens in as little as 1 h. This review will focus on the multiplex molecular panels that have received clearance from the FDA for the diagnosis of diarrheal disease and will highlight issues related to test performance, result interpretation, and cost-effectiveness of these new molecular diagnostic tools. Diarrheal disease remains a significant global health concern, with the World Health Organization estimating that there are ϳ1.7 billion total cases each year, resulting in Ͼ750,000 deaths among children younger than 5 years old (1). Gastrointestinal (GI) infection with bacteria (e.g., Clostridium difficile, Escherichia coli, Shigella), viruses (e.g., norovirus, rotavirus), or parasites (e.g., Cryptosporidium, Giardia) is a major cause of diarrheal illness worldwide, often resulting from contaminated food/water and poor sanitation. Rapid and accurate detection of GI pathogens is important so that appropriate therapy can be initiated and proper infection control and epidemiologic measures can be taken to help reduce or prevent the spread of disease (2, 3). Traditionally, the laboratory diagnosis of GI infections has relied on a combination of conventional techniques, including microscopy, culture, antigen detection, and individual real-time PCR assays. These methods have demonstrated good performance (4-6), but they are labor intensive, are time consuming, and require health care providers to select the appropriate tests, as a result of clinically indistinguishable illness caused by many infectious agents (7). Recently, there has been substantial interest in the development of multiplex molecular assays for the detection and identification of infectious diseases, including pathogens responsible for causing diarrhea. These syndromic panels allow health care providers to cast a broad net and achieve a timely diagnosis, which may be important in certain patient populations, such as immunocompromised hosts (ICH) and the critically ill (8). This review highlights three commercial multiplex panels (FilmArray GI panel [BioFire Diagnostics, Salt Lake City, UT], Luminex xTag GI pathogen panel [GPP] [Luminex Corporation, Toronto, Canada], and Nanosphere Verigene enteric pathogen [EP] test [Nanosphere, Inc., Northbrook, IL]) that have been cleared by the Food ...

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Section: How Do Multiplex Molecular Tests Perform Compared To Conventsupporting

confidence: 84%

Multiplex Molecular Panels for Diagnosis of Gastrointestinal Infection: Performance, Result Interpretation, and Cost-Effectiveness

2015

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“…However, microscopic examination reported a 23% Blastocystis hominis in adult travelers which is not covered by the xTAG GPP. All positive calls by xTAG GPP for Adenovirus, Rotavirus, Clostridium difficile and Cryptosporidium were confirmed, but not all positive calls for Norovirus and Giardia were confirmed 77 . In the study reported by Claas EC et al the Nororvirus performance of xTAG GPP is comparable to real-time PCR, with a 100% sensitivity and specificity for Norovirus GI and 92.5% sensitivity and 97.6% specificity for Norovirus GII.…”

Section: Current Enteric Multiplex Commercial Assaysmentioning

confidence: 89%

“…Other extraction platforms include Roche’s MagNA Pure 75 . Qiagens EZ1 virus mini kit 76 , Qiagen’s QIAsymphony 40 , and Abbott m2000sp instrument 77 .…”

Section: Current Enteric Multiplex Commercial Assaysmentioning

confidence: 99%

Multiplex Polymerase Chain Reaction Tests for Detection of Pathogens Associated with Gastroenteritis

Zhang

Morrison

Tang

2015

Clinics in Laboratory Medicine

147

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Synopsis A wide range of enteric pathogens can cause infectious gastroenteritis. Conventional diagnostic algorithms including culture, biochemical identification, immunoassay and microscopic examination are time consuming and often lack sensitivity and specificity. Advances in molecular technology have as allowed its use as clinical diagnostic tools. Multiplex PCR based testing has made its way to gastroenterology diagnostic arena in recent years. In this article we present a review of recent laboratory developed multiplex PCR tests and current commercial multiplex gastrointestinal pathogen tests. We will focus on two FDA cleared commercial syndromic multiplex tests: Luminex xTAG GPP and Biofire FimArray GI test. These multiplex tests can detect and identify multiple enteric pathogens in one test and provide results within hours. Multiplex PCR tests have shown superior sensitivity to conventional methods for detection of most pathogens. The high negative predictive value of these multiplex tests has led to the suggestion that they be used as screening tools especially in outbreaks. Although the clinical utility and benefit of multiplex PCR test are to be further investigated, implementing these multiplex PCR tests in gastroenterology diagnostic algorithm has the potential to improve diagnosis of infectious gastroenteritis.

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“…In a study by Beckmann et al using xTAG GPP testing on samples from pediatric patients presenting with symptoms of acute gastrointestinal disease, 7% were positive for C. difficile, 39% of which were from patients Ͻ1 year of age. The authors did not provide any further data regarding whether the detection of C. difficile correlated with CDI in these infants, but they did question whether the finding of C. difficile in this setting warrants treatment (45). In another study where xTAG GPP was used as the first line of detection of gastrointestinal pathogens in 211 prospectively collected specimens from a pediatric hospital, C. difficile was the number one pathogen detected (10.9%).…”

Section: Difficile Diagnostic Testsmentioning

confidence: 98%

Diagnosis of Clostridium difficile Infections in Children

Antonara

Leber

2016

J Clin Microbiol

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The detection and diagnosis of Clostridium difficile infection in pediatric populations have some unique considerations in comparison to testing in adults. The testing methodologies, including toxigenic culture, cell cytotoxicity, antigen detection, and, more recently, molecular testing, are the same in all age groups. However, limited data exist on the specific performance characteristics in children. In this review, we focus on the challenges of testing in pediatric populations and assess the available data on test performance in these populations. Additionally, a review of the existing guidance for testing is provided.

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Gastrointestinal pathogens detected by multiplex nucleic acid amplification testing in stools of pediatric patients and patients returning from the tropics

Cited by 51 publications

References 39 publications

Multiplex Molecular Panels for Diagnosis of Gastrointestinal Infection: Performance, Result Interpretation, and Cost-Effectiveness

Multiplex Molecular Panels for Diagnosis of Gastrointestinal Infection: Performance, Result Interpretation, and Cost-Effectiveness

Multiplex Polymerase Chain Reaction Tests for Detection of Pathogens Associated with Gastroenteritis

Diagnosis of Clostridium difficile Infections in Children

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