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 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 (rs = 0.217, P < 0.001). A mathematical approach such as FMM might be an alternative measure in optimizing the cut-off point for 13C-UBT in community-based studies, and a second method to determine H.pylori status for subjects with borderline value of 13C-UBT was necessary and recommended.
Highlights
The performance of diagnostic tests in intervention trials of Helicobacter pylori (H.pylori) eradication is crucial, since even minor inaccuracies can have major impact
We applied a finite mixture model (FMM) based on the expectation maximization (EM) algorithm to establish an optimal cut-off point of 13C-urea breath test (13C-UBT) in a modelling dataset randomly selected by clusters from the trial participants
We evaluated the consistency of H.pylori infection results between recomLine H.pylori test with Giemsa staining and 13C-UBT in the validation subjects
Summary
The performance of diagnostic tests in intervention trials of Helicobacter pylori (H.pylori) eradication is crucial, since even minor inaccuracies can have major impact. In 2011, we launched a randomized controlled intervention trial in Linqu County to prevent GC by eradication of H.pylori (Linqu Trial) in cooperation with the International Digestive Cancer Alliance and Technical University of Munich This trial aimed at assessing if eradication of H.pylori can effectively reduce GC incidence among 184,786 adults, in which 13C-urea breath test (13C-UBT) was applied to determine H.pylori status[6]. We applied a FMM based on the expectation maximization (EM) algorithm to establish an optimal cut-off point of 13C-UBT in a modelling dataset randomly selected by clusters (first 50 out of 980 villages participated in Linqu Trial) from the trial participants We validated it taking modified Giemsa stain as reference. Subjects within the “gray zone” of 13C-UBT were selected to assess if the cut-off value can be further optimized by recomLine assay
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