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. 2016 May;30(3):231-4.
doi: 10.1002/jcla.21841. Epub 2015 Jan 19.

Stability of (13) C-Urea Breath Test Samples Over Time in the Diagnosis of Helicobacter pylori

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Stability of (13) C-Urea Breath Test Samples Over Time in the Diagnosis of Helicobacter pylori

Tsachi Tsadok Perets et al. J Clin Lab Anal. 2016 May.

Abstract

Background: The accuracy and repeatability of breath test in the diagnosis of Helicobacter pylori infection have not been adequately investigated. Although it has been shown that storage for long periods does not affect the analysis results, no data are available on the effect of repetitive testing. In this study, our aim was to evaluate the repeatability of the analyses of breath samples at room temperature.

Methods: A total of 202 positive breath samples were collected in duplicates, before and after administration of 75 mg (13) C- urea dissolved in 100 ml of orange juice. Breath test results were expressed as delta (13) CO2 . The cut-off value was 3.5 parts per thousand. Each sample was analyzed in a mass spectrometer 7, 14, 21, and 28 days after collection. The accuracy calculation was based on the comparison of the delta (13) CO2 obtained in the three consecutive weeks following the first test run to the delta (13) CO2 obtained in the first test run.

Results: Two hundred (99%), 197 (97.52%), and 196 (97%) of the 202 samples tested positive in the second, third, and fourth test runs, respectively. The accuracy of the delta (13) CO2 was 98.6%, 99.2%, and 96.7% in the three consecutive runs, respectively.

Conclusion: Short-term storage of 1 month does not affect sample stability or the results of (13) C-urea breath tests in up to three consecutive repeats.

Keywords: 13C-urea breath test; H. pylori diagnosis; IRMS; reproducibility; test accuracy.

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Figures

Figure 1
Figure 1
Summary of accuracy values of three consecutive UBT runs over baseline. The delta 13CO2 of each of the positive and negative samples in the three consecutive test runs was compared to the delta 13CO2 of the first test run (baseline). The accuracy values represent the mean of the total accuracy values for each of the samples in the same test run.

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