A re-testing range is recommended for 13C- and 14C-urea breath tests for Helicobacterpylori infection in China

Gut Pathogens

Shuzhen Zhang¹  Haiting Chen¹  Xuehong Li¹  Dayong Sun²  Xiangyu Wang³  Aijun Liu⁴  Yongsheng He⁴  Xiaofeng Li⁵  Eng Guan Chua⁶  Barry J. Marshall⁶  Chin Yen Tay⁶  Michael J. Wise⁷ 

[1] Department of Clinical Laboratory, Kuichong People’s Hospital, 518116, Shenzhen, China;Department of Gastroenterology, Health Science Center, Shenzhen Second People’s Hospital, The First Affiliated Hospital of Shenzhen University, 518035, Shenzhen, China;Department of Gastroenterology, Health Science Center, Shenzhen Second People’s Hospital, The First Affiliated Hospital of Shenzhen University, 518035, Shenzhen, China;Department of Clinical Laboratory, Kuichong People’s Hospital, 518116, Shenzhen, China;Department of Gastroenterology, Kuichong People’s Hospital, 518116, Shenzhen, China;Department of Nuclear Medicine, Shenzhen People’s Hospital, 518001, Shenzhen, China;The Marshall Centre for Infectious Diseases Research and Training, University of Western Australia, 6009, Perth, Australia;The Marshall Centre for Infectious Diseases Research and Training, University of Western Australia, 6009, Perth, Australia;Department of Computer Science and Software Engineering, University of Western Australia, 6009, Perth, Australia;

关键词: Helicobacter pylori;    Urea breath test;    Diagnostic performance;    Indeterminate range;   

DOI  :  10.1186/s13099-021-00435-3

来源: Springer

【 摘 要 】

BackgroundThe urea breath test (UBT) is widely used for diagnosing Helicobacter pylori infection. In the Shenzhen Kuichong People’s Hospital, some UBT findings were contradictory to the histology outcomes, therefore this study aimed to assess and compare the diagnostic performance of both 13C- and 14C-UBT assays.MethodsWe recruited 484 H. pylori-treatment naïve patients, among which 217 and 267 were tested by the 13C-UBT or 14C-UBT, respectively. The cutoff value for H. pylori positivity based on manufacturer’s instruction was 4% delta over baseline (DOB) for the 13C-UBT, and 100 disintegrations per minute (DPM) for the 14C-UBT. Gastric biopsies of the antrum and corpus were obtained during endoscopy for histopathology.ResultsIn patients who were tested using the 13C-UBT kit, histopathology was positive in 136 out of 164 UBT-positive patients (82.9% concordance), and negative in 46 out of 53 UBT-negative cases (86.8% concordance). For the 14C-UBT-tested patients, histopathology was positive for H. pylori in 186 out of 220 UBT-positive patients (84.5% concordance), and negative in 41 out of 47 UBT-negative cases (87.2% concordance). While the 13C-UBT and 14C-UBT each had a high sensitivity level of 95.1% and 96.9%, respectively, their specificity was low, at 62.2% and 54.7%, respectively. By using new optimal cutoff values and including an indeterminate range (3–10.3% DOB for 13C-UBT and 87–237 DPM for 14C-UBT), the specificity values can be improved to 76.7% and 76.9% for the 13C- and 14C-UBT, respectively.ConclusionsThe establishment of an indeterminate range is recommended to allow for repeated testing to confirm H. pylori infection, and thereby avoiding unnecessary antibiotic treatment.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000041570. Registered 29 December 2020- Retrospectively registered, http://www.chictr.org.cn/edit.aspx?pid=66416&htm=4

【 授权许可】

CC BY