The World Health Organization has reported 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 in children under five years old.[1,2] Each year, diarrhea results in approximately 760,000 preventable deaths of children under the age of five years. Diarrhea in this age group is also a leading cause of malnutrition. Most cases of this disease are related to unsafe drinking-water, inadequate sanitation, and poor hygiene.[1,2]
Detection and identification of the etiological agents of acute bacterial diarrhea are important for both the treatment of individual patients and for the management of diarrheal diseases of public health importance. Conventional bacterial culture remains the gold standard for the aforementioned detection, even though stool culture has relatively low sensitivity and requires a significant amount of labor. The use of nucleic acid amplification methods to detect and identify the etiological agents of acute bacterial diarrhea could have a significant impact on the laboratory diagnostic process, clinical approach, and epidemiology of this disease.[3–5]
The objective of this study was to examine the laboratory impact of a new molecular platform (use of the BD MAX Enteric Bacterial Panel on the BD MAX System) on turnaround time, associated laboratory processes, and the cost of providing results with this system compared to conventional culture methods. Results of both conventional culture (including a commercial immunoassay for shiga-toxin) and the EBP, which include tests for the detection of Salmonella spp., Shigella spp./Enteroinvasive Escherichia coli (EIEC), Campylobacter spp. (jejuni and coli), and Shiga toxin 1 and 2 genes in stool specimens were evaluated. Lean and Six Sigma processes were used to analyze the time from sample receipt to actionable result for conventional stool culture and the EBP. The following "events or decisions per specimen" were determined: any action or thought process that must occur to process and issue a result, the overall distance traveled per sample as a measure of efficiency, and the operating costs of the two systems.
(The results of this study were presented, in part, at the 24th European Congress of Clinical Microbiology and Infectious Diseases, Barcelona, Spain, May 10–13, 2014 and at the 114th General Meeting of the American Society for Microbiology, Boston MA, May 17–20, 2014.)
BMC Clin Pathol. 2015;15(9) © 2015 BioMed Central, Ltd.