A parallel diagnostic accuracy study of three molecular panels for the detection of bacterial gastroenteritis

Biswas, J S; AlAli, Ahmad M.; Rajput, Pradeep Kumar; Smith, David George Emslie; Goldenberg, Simon

doi:10.1007/s10096-014-2177-9

Cited by 32 publications

(17 citation statements)

References 18 publications

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“…in the prospective arm, there was little difference in performance between prospective and retrospective data sets (Table 3). Reduced sensitivity for Salmonella in comparison to culture has been reported (12,17,21,25). Cunningham et al attributed reduced sensitivity to the enhancement of the culture method with a selenite enrichment broth (12).…”

Section: Discussionmentioning

confidence: 99%

Multicenter Evaluation of the BD Max Enteric Bacterial Panel PCR Assay for Rapid Detection of Salmonella spp., Shigella spp., Campylobacter spp. (C. jejuni and C. coli), and Shiga Toxin 1 and 2 Genes

et al. 2015

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i Diarrhea due to enteric bacterial pathogens causes significant morbidity and mortality in the United States and worldwide. However, bacterial pathogens may be infrequently identified. Currently, culture and enzyme immunoassays (EIAs) are the primary methods used by clinical laboratories to detect enteric bacterial pathogens. We conducted a multicenter evaluation of the BD Max enteric bacterial panel (EBP) PCR assay in comparison to culture for the detection of Salmonella spp., Shigella spp., Campylobacter jejuni, and Campylobacter coli and an EIA for Shiga toxins 1 and 2. A total of 4,242 preserved or unpreserved stool specimens, including 3,457 specimens collected prospectively and 785 frozen, retrospective samples, were evaluated. Compared to culture or EIA, the positive percent agreement (PPA) and negative percent agreement (NPA) values for the BD Max EBP assay for all specimens combined were as follows: 97.1% and 99.2% for Salmonella spp., 99.1% and 99.7% for Shigella spp., 97.2% and 98.4% for C. jejuni and C. coli, and 97.4% and 99.3% for Shiga toxins, respectively. Discrepant results for prospective samples were resolved with alternate PCR assays and bidirectional sequencing of amplicons. Following discrepant analysis, PPA and NPA values were as follows: 97.3% and 99.8% for Salmonella spp., 99.2% and 100% for Shigella spp., 97.5% and 99.0% for C. jejuni and C. coli, and 100% and 99.7% for Shiga toxins, respectively. No differences in detection were observed for samples preserved in Cary-Blair medium and unpreserved samples. In this large, multicenter study, the BD Max EBP assay showed superior sensitivity compared to conventional methods and excellent specificity for the detection of enteric bacterial pathogens in stool specimens. The World Health Organization reports that, worldwide, there are nearly 1.7 billion cases of diarrheal disease every year and that diarrheal disease is the second leading cause of death of children Ͻ5 years old. Each year, diarrhea kills ϳ760,000 children under the age of 5 years, and most importantly, it is preventable and treatable. Diarrhea is also a leading cause of malnutrition in this same age group. Most of this disease is related to unsafe drinking water, inadequate sanitation, and poor hygiene (1, 2).Acute gastroenteritis is caused by a number of bacterial, viral, and parasitic agents (3). In the United States, noroviruses cause most cases of self-limited, acute gastroenteritis. However, Salmonella, Campylobacter, Shigella, and Shiga toxin-producing Escherichia coli (STEC) are the most common diarrheagenic bacteria, and they are usually associated with foodborne illness (4). Furthermore, Shigella is more frequently transmitted from person to person due to the low infectious dose. Importantly, agents of gastroenteritis may not be distinguished clinically. Identifying the cause of diarrhea is important for both the treatment of individual patients and public health intervention through outbreak management (5).Conventional microbiological cultures remain the gold standard...

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Section: Discussionmentioning

confidence: 99%

Multicenter Evaluation of the BD Max Enteric Bacterial Panel PCR Assay for Rapid Detection of Salmonella spp., Shigella spp., Campylobacter spp. (C. jejuni and C. coli), and Shiga Toxin 1 and 2 Genes

et al. 2015

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“…All three molecular panels gave much faster turnaround time than culture: <3 h vs 66.5 h for culture. The BD MAX™ panel was noted as the fastest, easiest to use and most flexible 67 .…”

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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“…The recently commercialized BD Max system (Becton Dickinson, Pont-de-Claix, France) combines the extraction and amplification steps on the same instrument, shortening the hands-on time and allowing its use in emergency molecular diagnostic testing. Dedicated analyte kits (23)(24)(25)(26) but also master mix from other companies (27) and laboratory-developed methods (28) can be used on this open, fully automated platform. Recently, the BD Max system was used to perform in 2 separate assays a real-time PCR test detecting HSV and VZV in skin and mucosal lesions (29).…”

mentioning

confidence: 99%

Development and Validation of a Laboratory-Developed Multiplex Real-Time PCR Assay on the BD Max System for Detection of Herpes Simplex Virus and Varicella-Zoster Virus DNA in Various Clinical Specimens

et al. 2015

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A multiplex real-time PCR (quantitative PCR [qPCR]) assay detecting herpes simplex virus (HSV) and varicella-zoster virus (VZV)DNAH erpes simplex viruses 1 and 2 (HSV-1 and -2, respectively) and varicella-zoster virus (VZV) are human double-stranded DNA viruses belonging to the Herpesviridae family. In immunocompetent hosts, benign vesicular eruption of the skin and mucosa occurs during either the primary infection or reactivation episodes (1). However, life-threatening manifestations, mainly related to virus neurovirulence, can be observed (2), HSV-1 and VZV being the first and second most common causes of viral encephalitis, respectively (3, 4). These viruses are associated with mortality and morbidity, especially when treatment with acyclovir is delayed (5). HSV-2 is more likely responsible for meningitis (1). HSV-2 and VZV are also implicated in neonatal infections (1,6,7).Due to similarities in the clinical presentations of the diseases caused by these 3 herpesviruses and other pathogens, virological testing is often needed. Accurate and specific diagnosis is of special importance in cases of severe infection or in infection occurring in immunosuppressed patients who can present atypical clinical pictures (8). In replacement of cell culture and immune detection of viral antigens, molecular assays are currently the main tool used for the virological diagnosis of infections related to HSV and VZV. This trend is due to the multiple advantages of nucleic acid testing (NAT), including the rapid availability of results, its adaptation to a wide diversity of clinical specimens, the capacity for automation, and, mostly, its high sensitivity and specificity. Several FDA-approved or CE-marked in vitro diagnostic (IVD) kits are available for detecting these viruses in various specimens (9-11). However, all of them propose separate detection for HSV and VZV DNA, and only a few multiplex assays including both agents have been published as laboratory-developed tests (LDTs) (10, 12).Although detection of viral DNA is the gold standard for the virological diagnosis of neurological severe infections (3), to date, no commercial fully automated PCR assay detecting both HSV and VZV is available. However, an FDA-approved assay for HSV detection in cerebrospinal fluid (CSF) was recently validated for clinical use (13,14). As low viral loads (Ͻ500 copies/ml) are not infrequent in CSF of patients suffering encephalitis associated with , it was recommended to reach a sensitivity of at least 200 copies/ml for the detection of this agent in CSF (21). The same need for sensitive tests is found with encephalitis associated with VZV (15, 22). The recently commercialized BD Max system (Becton Dickinson, Pont-de-Claix, France) combines the extraction and amplification steps on the same instrument, shortening the hands-on time and allowing its use in emergency molecular diagnostic testing. Dedicated analyte kits (23-26) but also master mix from other companies (27) and laboratory-developed methods (28) can be

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A parallel diagnostic accuracy study of three molecular panels for the detection of bacterial gastroenteritis

Cited by 32 publications

References 18 publications

Multicenter Evaluation of the BD Max Enteric Bacterial Panel PCR Assay for Rapid Detection of Salmonella spp., Shigella spp., Campylobacter spp. (C. jejuni and C. coli), and Shiga Toxin 1 and 2 Genes

Multicenter Evaluation of the BD Max Enteric Bacterial Panel PCR Assay for Rapid Detection of Salmonella spp., Shigella spp., Campylobacter spp. (C. jejuni and C. coli), and Shiga Toxin 1 and 2 Genes

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

Development and Validation of a Laboratory-Developed Multiplex Real-Time PCR Assay on the BD Max System for Detection of Herpes Simplex Virus and Varicella-Zoster Virus DNA in Various Clinical Specimens

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