Cut-off optimization for ¹³C-urea breath test in a community-based trial by mathematic, histology and serology approach.

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 ¹³C-urea breath test (¹³C-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 ¹³C-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

SUBMITTER: Li ZX 

PROVIDER: S-EPMC5437005 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature