Published online Feb 14, 2024. doi: 10.3748/wjg.v30.i6.579
Peer-review started: November 14, 2023
First decision: December 5, 2023
Revised: December 16, 2023
Accepted: January 16, 2024
Article in press: January 16, 2024
Published online: February 14, 2024
The urea breath test (UBT) has become a widely accepted non-invasive method for detecting Helicobacter pylori (H. pylori). While numerous studies have confirmed its high accuracy, its reliability is often hindered by inherent limitations.
In a previous investigation, the diagnostic accuracy of the UBT, which encompasses both 13C-UBT and 14C-UBT, was evaluated in adult patients with dyspepsia to determine the presence of H. pylori infection. Although the test demonstrated a high degree of precision, its reliability was compromised by significant and unexplained heterogeneity, which persisted even after conducting subgroup analyses. This trend continued in subsequent studies, with similar challenges encountered in determining pooled estimates of diagnostic accuracy for 14C-UBT. Furthermore, a subsequent systematic review revealed that the variability in thresholds and reference standards across studies limited the available data for pooling accuracy measures at specific UBT thresholds. These findings underscore the need for a rigorous statistical synthesis to clarify and reconcile the diagnostic accuracy of the UBT for the diagnosis of H. pylori infection, addressing challenges identified in prior research.
To evaluate and contrast the diagnostic accuracy of 13C-UBT and 14C-UBT for H. pylori infection in adult patients with dyspepsia.
We conducted independent searches of PubMed/MEDLINE, EMBASE, and Cochrane Central databases until April 2022, focusing on diagnostic accuracy studies that evaluated at least one of the index tests (13C-UBT or 14C-UBT) against a reference standard. We utilized the QUADAS-2 tool to assess the methodological quality of the studies, and we calculated sensitivity, specificity, positive and negative test likelihood ratios (LR+ and LR-), as well as the diagnostic odds ratio (DOR) and their 95% confidence intervals using the bivariate random-effects model. We conducted subgroup analyses based on urea dosing, time after urea administration, and assessment technique. To investigate a possible threshold effect, we conducted Spearman correlation analysis, and we generated summary receiver operating characteristic (SROC) curves to assess heterogeneity. Lastly, we visually inspected a funnel plot and used Egger’s test to evaluate publication bias.
A screening of 4621 studies led to the selection of 60 articles for inclusion in a diagnostic test accuracy meta-analysis after full-text reading. Our analysis highlights the superior diagnostic accuracy of 13C-UBT compared to 14C-UBT, as evidenced by higher sensitivity (96.60% vs 96.15%), specificity (96.93% vs 89.84%), likelihood ratios (LR+ 22.00 vs 10.10; LR- 0.05 vs 0.06), and AUC values (0.979 vs 0.968). Particularly noteworthy is the significantly higher DOR of 13C-UBT (586.47) compared to 14C-UBT (DOR 226.50), establishing 13C-UBT as the preferred diagnostic tool for individuals with dyspepsia and H. pylori infection. Correlation analysis indicated no threshold effect for both 13C-UBT (r = 0.48) and 14C-UBT (r = -0.01), and the SROC curves consistently demonstrated accurate performance for both tests. The high AUC values (13C-UBT: 0.979; 14C-UBT: 0.968), nearing 1.00, further affirm the excellent accuracy of both UBT variants, solidifying their reliability as diagnostic tools in clinical practice.
Our study establishes 13C-UBT as the superior diagnostic approach over 14C-UBT. Furthermore, our findings underscore the critical importance of meticulously considering factors such as urea dosage, assessment timing, and measurement techniques for both tests to optimize diagnostic accuracy. However, it is paramount for researchers and clinicians to thoroughly evaluate the strengths and limitations of our conclusions before integrating them into clinical practice.
Future research should focus on improving the comprehension, practicality, and dependability of UBTs for H. pylori infection. This endeavor involves refining techniques, examining sources of variability, exploring threshold effects, conducting longitudinal and comparative investigations, addressing biases, and assessing cost-effectiveness.