Abstract
We investigated the efficiency of the Verigene Enteric Pathogens Nucleic Acid Test (Verigene EP test), which is an automated microarray-based assay system that enables rapid and simultaneous genetic detection of gastrointestinal pathogens and toxins, including those in the Campylobacter Group, Salmonella species, Shigella species, the Vibrio Group, Yersinia enterocolitica, Shiga toxin 1 and 2, norovirus GI/GII, and rotavirus A. Three clinical laboratories evaluated the Verigene EP test, using 268 stool samples for bacterial and toxin genes and 167 samples for viral genes. Culture-based reference methods were used for the detection of bacteria and toxins, while a different molecular assay was used for viral detection. The overall concordance rate between the Verigene EP test and the reference methods for the 1940 assays was 99.0%. The overall sensitivity and specificity of the Verigene EP test were 97.0% and 99.3%, respectively. Of the 19 samples with discordant results, 13 samples were false positives and six were false negatives. The Verigene EP test simultaneously detected two targets in 11 samples; overall, the test demonstrated high efficiency in detecting crucial diarrheagenic pathogens, indicating its suitability for clinical practice.
Highlights
Acute infectious diarrhea is a major cause of outpatient visits and hospitalization[1]
Since only a few previous studies have investigated the utility of this test[3,4], and epidemiological differences affect the performance of diagnostic m ethods[5], we conducted a multicenter evaluation in Japan to assess the ability of the Verigene EP test to detect crucial enteric pathogens
Of the 268 samples tested for bacteria and toxins and the 167 samples tested for viruses, 256 and 160 samples respectively (95.5% and 95.8%) had fully concordant results between the Verigene EP test and the reference methods
Summary
Acute infectious diarrhea is a major cause of outpatient visits and hospitalization[1]. Since most diarrheal illnesses are self-limited, microbiological testing is not necessary for all patients. Rapid etiological identification is required for those with serious symptoms and conditions such as systemic illness, fever, and bloody stool[2], to enable effective antimicrobial treatment against specific pathogens. Because some patients with infectious diarrhea should be isolated to prevent pathogen transmission in hospitals, more prompt and accurate methods are needed to detect crucial gastrointestinal pathogens. Since only a few previous studies have investigated the utility of this test[3,4], and epidemiological differences affect the performance of diagnostic m ethods[5], we conducted a multicenter evaluation in Japan to assess the ability of the Verigene EP test to detect crucial enteric pathogens
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