Abstract
Diarrheal disease is a complex syndrome that remains a leading cause of global childhood morbidity and mortality. The diagnosis of enteric pathogens in a timely and precise manner is important for making treatment decisions and informing public health policy, but accurate diagnosis is a major challenge in industrializing countries. Multiplex molecular diagnostic techniques may represent a significant improvement over classical approaches. We evaluated the Luminex xTAG gastrointestinal pathogen panel (GPP) assay for the detection of common enteric bacterial and viral pathogens in Vietnam. Microbiological culture and real-time PCR were used as gold standards. The tests were performed on 479 stool samples collected from people admitted to the hospital for diarrheal disease throughout Vietnam. Sensitivity and specificity were calculated for the xTAG GPP for the seven principal diarrheal etiologies. The sensitivity and specificity for the xTAG GPP were >88% for Shigella spp., Campylobacter spp., rotavirus, norovirus genotype 1/2 (GI/GII), and adenovirus compared to those of microbiological culture and/or real-time PCR. However, the specificity was low (∼60%) for Salmonella species. Additionally, a number of important pathogens that are not identified in routine hospital procedures in this setting, such as Cryptosporidium spp. and Clostridium difficile, were detected with the GPP. The use of the Luminex xTAG GPP for the detection of enteric pathogens in settings, like Vietnam, would dramatically improve the diagnostic accuracy and capacity of hospital laboratories, allowing for timely and appropriate therapy decisions and a wider understanding of the epidemiology of pathogens associated with severe diarrheal disease in low-resource settings.
Highlights
Diarrheal disease remains a considerable public health challenge and is responsible for 0.8 million deaths and close to 90,000 disability-adjusted life years annually [1, 2], the majority of which occur in children Ͻ5 years of age in industrializing regions [3]
We aimed to evaluate the sensitivity and specificity of the xTAG gastrointestinal pathogen panel (GPP) platform against those of conventional diagnostic techniques on clinical samples isolated from patients hospitalized with diarrheal disease in Vietnam
479 stool samples were collected from 92 adults (Ͼ15 years) and 387 children (Յ15 years old) admitted to the hospital with diarrheal disease in Vietnam between 2009 and 2014
Summary
Diarrheal disease remains a considerable public health challenge and is responsible for 0.8 million deaths and close to 90,000 disability-adjusted life years annually [1, 2], the majority of which occur in children Ͻ5 years of age in industrializing regions [3]. Rotavirus remains the most common cause of diarrhea in children Ͻ2 years of age [4, 5], the introduction of rotavirus vaccines in many countries has led to a fall in incidence in locations where uptake has been significant [6, 7] Bacterial pathogens, such as Shigella spp., enterotoxigenic Escherichia coli (ETEC), Campylobacter spp., and Salmonella spp., norovirus, and the parasitic pathogens Giardia and Cryptosporidium spp. are known to be present frequently in the stools of young children with diarrhea in resource-poor regions [4, 5, 8]. As the etiology of diarrheal disease is diverse and complex, sensitive and specific diagnostics are required for prompt and accurate identification and treatment
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