title: Evaluation of a multiplex real-time PCR kit Amplidiag® Bacterial GE in the detection of bacterial pathogens from stool samples.
abstract: This study evaluated the performance of a new commercially available multiplex real-time PCR kit Amplidiag® Bacterial GE in the systematic screening of bacterial pathogens causing gastroenteritis. Stool samples from 1168 patients were analyzed with Amplidiag® Bacterial GE, stool culture, and molecular reference tests, and the sensitivity and specificity of Amplidiag® Bacterial GE were determined by comparing the results to the reference tests. The evaluation showed good performance for Amplidiag® Bacterial GE: sensitivity and specificity of the test was 100/99.7% for Salmonella, 100/99.8% for Yersinia, 98.8/99.2% for Campylobacter, 92.9/100% for Shigella/EIEC, 100/99.9% for EHEC, 92.9/99.8% for ETEC, 98.9/99.2% for EPEC, and 100/99.8% EAEC, respectively. When compared with stool culture, Amplidiag® Bacterial GE was found to be more sensitive. This study suggests that Amplidiag® Bacterial GE is suitable for screening bacterial pathogens from stool samples. However, this study only demonstrates the performance of Amplidiag® Bacterial GE in low endemic settings, as the number of positive findings in this study was relatively low.
authors.affiliation: Department of Medical Microbiology and Immunology, University of Turku, Kiinamyllynkatu 13, 20520 Turku, Finland; Department of Clinical Microbiology and Immunology, Turku University Hospital, Kiinamyllynkatu 13, 20520 Turku, Finland. Electronic address: anniina.rintala@utu.fi.
authors.forename: Anniina
authors.initials: A
authors.lastname: Rintala
authors.affiliation: Department of Medical Microbiology and Immunology, University of Turku, Kiinamyllynkatu 13, 20520 Turku, Finland; Department of Clinical Microbiology and Immunology, Turku University Hospital, Kiinamyllynkatu 13, 20520 Turku, Finland. Electronic address: laevmu@utu.fi.
authors.forename: Eveliina
authors.initials: E
authors.lastname: Munukka
authors.affiliation: Department of Laboratory Medicine, Division of Clinical Microbiology, Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden. Electronic address: andrej.weintraub@ki.se.
authors.forename: Andrej
authors.initials: A
authors.lastname: Weintraub
authors.affiliation: Department of Laboratory Medicine, Division of Clinical Microbiology, Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden. Electronic address: mans.ullberg@karolinska.se.
authors.forename: Måns
authors.initials: M
authors.lastname: Ullberg
authors.affiliation: Department of Medical Microbiology and Immunology, University of Turku, Kiinamyllynkatu 13, 20520 Turku, Finland; Department of Clinical Microbiology and Immunology, Turku University Hospital, Kiinamyllynkatu 13, 20520 Turku, Finland. Electronic address: eerola@utu.fi.
authors.forename: Erkki
authors.initials: E
authors.lastname: Eerola
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001431:Bacteriological Techniques / Q000379:methods*; D002167:Campylobacter / Q000302:isolation & purification; D002648:Child; D002675:Child, Preschool; D005243:Feces / Q000382:microbiology*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D060885:Multiplex Polymerase Chain Reaction; D012475:Salmonella / Q000302:isolation & purification; D012680:Sensitivity and Specificity; D012760:Shigella / Q000302:isolation & purification; D015007:Yersinia / Q000302:isolation & purification; D055815:Young Adult
keywords: Bacterial gastroenteritis; Diarrhea; Molecular diagnostics; Multiplex real-time PCR