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Park, Park, Lee, Lee, Yong, and Kim: Comparison Between a New Low Dose Urea Capsule Test and the Conventional UBiT® Tablet Test for the Detection of Helicobacter pylori Infection
Original Article

Korean J Leg Med 2006;26(2):81-85.

Published online: 10 February 2006

DOI: https://doi.org/10.3343/kjlm.2006.26.2.81

Comparison Between a New Low Dose Urea Capsule Test and the Conventional UBiT® Tablet Test for the Detection of Helicobacter pylori Infection

Seo-Jin Park, M.D.1, Youn Hee Park, M.D.1, Sang In Lee, M.D.2, Duk Chul Lee, M.D.3, Dongeun Yong, M.D.1, Jeong-Ho Kim, M.D.1

1Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea

2Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea

3Department of Family Medicine, Yonsei University College of Medicine, Seoul, Korea

Received 11 November 2005       Revised 11 February 2006       Accepted 7 March 2006

Copyright © 2006 The Korean Society for Legal Medicine

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

The urea breath test (UBT) is regarded as a highly reliable, noninvasive tool for diagnosing Helicobacter pylori infection. We compared a recently developed low-dose 38 mg 13C-urea capsule, which is able to eliminate oral urease effects and does not require positional changes during the test, with the conventionally used 100 mg 13C-urea tablet method.

Methods

Thirty-nine volunteers were tested under informed consent with both 13C-UBT methods, Helifinder® and UBiT-IR300®, with a minimum 2-week washout period. The pre-ingestion and 20-minute post-ingestion breath samples were analyzed with an isotope ratio mass spectrometer for Helifinder, and a nondispersive isotope-selective infrared spectrophotometer for UBiT samples.

Results

Helifinder method showed excellent agreement with UBiT among 19 positive and 20 negative cases (weighted kappa value, 1.0). Helifinder results (y) showed good agreement but with a proportional bias compared to UBiT results (x) by Passing and Bablok method (y=0.551x–0.255, r=0.74, P<0.0001).

Conclusions

Since the low-dose 38 mg 13C-urea capsule (Helifinder) test, which is more convenient and economic, showed comparable results with the conventional UBiT method, it can be used as an alternative for the diagnosis of H. pylori infection.

Keywords: Urea breath test, Helicobacter pylori, Low-dose urea

References

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Fig. 1.
Passing and Bablok comparison of Helifinder® and UBiT® 13C values (‰). Dashed lines show the 95% confidence limits of the regression line.
kjlm-26-81f1.tif
Table 1.
Patient distribution of urea breath test-positive versus – negative results
Gender (No) No. of patients with urea breat test
Positive Negative
Male (12) 6 6
Female (27) 13 14
Total (39) 19 20
Table 2.
Agreement of 13C-urea breath test results between Helifinder® and UBiT®
UBT Method HeliFinder®
 Total
Negative Positive
UBiT®      
 Negative 20 0 20
 Positive 0 19 19
 Total 20 19 39
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