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Titel:

Cut-off optimization for C-urea breath test in a community-based trial by mathematic, histology and serology approach.

Dokumenttyp:
Journal Article; 1
Autor(en):
Li, Zhe-Xuan; Huang, Lei-Lei; Liu, Cong; Formichella, Luca; Zhang, Yang; Wang, Yu-Mei; Zhang, Lian; Ma, Jun-Ling; Liu, Wei-Dong; Ulm, Kurt; Wang, Jian-Xi; Zhang, Lei; Bajbouj, Monther; Li, Ming; Vieth, Michael; Quante, Michael; Zhou, Tong; Wang, Le-Hua; Suchanek, Stepan; Soutschek, Erwin; Schmid, Roland; Classen, Meinhard; You, Wei-Cheng; Gerhard, Markus; Pan, Kai-Feng
Abstract:
The performance of diagnostic tests in intervention trials of Helicobacter pylori (H.pylori) eradication is crucial, since even minor inaccuracies can have major impact. To determine the cut-off point for C-urea breath test (C-UBT) and to assess if it can be further optimized by serologic testing, mathematic modeling, histopathology and serologic validation were applied. A finite mixture model (FMM) was developed in 21,857 subjects, and an independent validation by modified Giemsa staining was conducted in 300 selected subjects. H.pylori status was determined using recomLine H.pylori assay in 2,113 subjects with a borderline C-UBT results. The delta over baseline-value (DOB) of 3.8 was an optimal cut-off point by a FMM in modelling dataset, which was further validated as the most appropriate cut-off point by Giemsa staining (sensitivity = 94.53%, specificity = 92.93%). In the borderline population, 1,468 subjects were determined as H.pylori positive by recomLine (69.5%). A significant correlation between the number of positive H.pylori serum responses and DOB value was found (r = 0.217, P < 0.001). A mathematical approach such as FMM might be an alternative measure in optimizing the cut-off point for C-UBT in community-based studies, and a second method to determine H.pylori status for subjects with borderline value of C-UBT was necessary and recommended.
Zeitschriftentitel:
Sci Rep
Jahr:
2017
Band / Volume:
7
Heft / Issue:
1
Seitenangaben Beitrag:
2072
Sprache:
eng
Volltext / DOI:
doi:10.1038/s41598-017-02180-7
PubMed:
http://view.ncbi.nlm.nih.gov/pubmed/28522798
Print-ISSN:
2045-2322
TUM Einrichtung:
II. Medizinische Klinik und Poliklinik (Gastroenterologie); Institut für Medizinische Mikrobiologie, Immunologie und Hygiene; Institut für Medizinische Statistik und Epidemiologie
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