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 serolog...
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2017
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oai:doaj.org-article:cd9848f524514ca58d818a07ae8237182021-12-02T12:32:40ZCut-off optimization for 13C-urea breath test in a community-based trial by mathematic, histology and serology approach10.1038/s41598-017-02180-72045-2322https://doaj.org/article/cd9848f524514ca58d818a07ae8237182017-05-01T00:00:00Zhttps://doi.org/10.1038/s41598-017-02180-7https://doaj.org/toc/2045-2322Abstract 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.Zhe-Xuan LiLei-Lei HuangCong LiuLuca FormichellaYang ZhangYu-Mei WangLian ZhangJun-Ling MaWei-Dong LiuKurt UlmJian-Xi WangLei ZhangMonther BajboujMing LiMichael ViethMichael QuanteTong ZhouLe-Hua WangStepan SuchanekErwin SoutschekRoland SchmidMeinhard ClassenWei-Cheng YouMarkus GerhardKai-Feng PanNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 7, Iss 1, Pp 1-8 (2017) |
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Medicine R Science Q |
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Medicine R Science Q Zhe-Xuan Li Lei-Lei Huang Cong Liu Luca Formichella Yang Zhang Yu-Mei Wang Lian Zhang Jun-Ling Ma Wei-Dong Liu Kurt Ulm Jian-Xi Wang Lei Zhang Monther Bajbouj Ming Li Michael Vieth Michael Quante Tong Zhou Le-Hua Wang Stepan Suchanek Erwin Soutschek Roland Schmid Meinhard Classen Wei-Cheng You Markus Gerhard Kai-Feng Pan Cut-off optimization for 13C-urea breath test in a community-based trial by mathematic, histology and serology approach |
| description |
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. |
| format |
article |
| author |
Zhe-Xuan Li Lei-Lei Huang Cong Liu Luca Formichella Yang Zhang Yu-Mei Wang Lian Zhang Jun-Ling Ma Wei-Dong Liu Kurt Ulm Jian-Xi Wang Lei Zhang Monther Bajbouj Ming Li Michael Vieth Michael Quante Tong Zhou Le-Hua Wang Stepan Suchanek Erwin Soutschek Roland Schmid Meinhard Classen Wei-Cheng You Markus Gerhard Kai-Feng Pan |
| author_facet |
Zhe-Xuan Li Lei-Lei Huang Cong Liu Luca Formichella Yang Zhang Yu-Mei Wang Lian Zhang Jun-Ling Ma Wei-Dong Liu Kurt Ulm Jian-Xi Wang Lei Zhang Monther Bajbouj Ming Li Michael Vieth Michael Quante Tong Zhou Le-Hua Wang Stepan Suchanek Erwin Soutschek Roland Schmid Meinhard Classen Wei-Cheng You Markus Gerhard Kai-Feng Pan |
| author_sort |
Zhe-Xuan Li |
| title |
Cut-off optimization for 13C-urea breath test in a community-based trial by mathematic, histology and serology approach |
| title_short |
Cut-off optimization for 13C-urea breath test in a community-based trial by mathematic, histology and serology approach |
| title_full |
Cut-off optimization for 13C-urea breath test in a community-based trial by mathematic, histology and serology approach |
| title_fullStr |
Cut-off optimization for 13C-urea breath test in a community-based trial by mathematic, histology and serology approach |
| title_full_unstemmed |
Cut-off optimization for 13C-urea breath test in a community-based trial by mathematic, histology and serology approach |
| title_sort |
cut-off optimization for 13c-urea breath test in a community-based trial by mathematic, histology and serology approach |
| publisher |
Nature Portfolio |
| publishDate |
2017 |
| url |
https://doaj.org/article/cd9848f524514ca58d818a07ae823718 |
| work_keys_str_mv |
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