Background: 13C breath test analysis requires accurate 13CO2 measurements. Aim: To perform a multicentre study to evaluate the repeatability and reproducibility of breath 13CO2 analysis. Methods: Two series of 25 paired randomly coded tubes (each consisting of 23 13CO2-enriched breath samples and two samples of standard reference pure CO2 with certified δ13CPDB) were sent to participating centres for 13CO2 measurement. Each series of tubes was analysed 10 days apart. The repeatability and reproducibility of 13C measurements was assessed by Mandel's k and h statistics. Results: Twenty-two centres participated in the study: 18 showed good inter- and intra-laboratory variability, whilst four showed abnormally high inter- or intra-laboratory variability. Breath test results were also significantly affected by the accuracy of the 13C analytical procedures. Conclusions: A low accuracy of 13C measurements may significantly affect the results of breath tests, leading to inappropriate clinical decisions. Standardization of 13C analysis is required to guarantee optimal 13C measurements and accurate 13C breath test results.
ASJC Scopus subject areas
- Pharmacology (medical)
- Pharmacology, Toxicology and Pharmaceutics(all)