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...