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

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