Evaluation of the two immunochromatographic methods for detecting urine and serum IgG antibodies to Helicobacter pylori and comparison of accuracy and clinical utility

Huang Ming Hu, Chao Hung Kuo, Yi Ching Lo, Ming Tsang Wu, I. Chen Wu, Chien Yu Lu, Yu Chung Su, Fang Jong Yu, Yi Chen Lee, Shiu Ru Lin, Chiang Shin Liu, Chang Ming Jan, Wen Ming Wang, Deng Chyang Wu

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Abstract

Background/Aims: To evaluate the accuracy and clinical utility of two immunochromatographic methods, the STAT-PAK and RAPIRUN tests, in detecting H. pylori antibodies in serum and in urine separately. Methodology: 130 patients undergoing gastroendoscopy (70 men and 60 women; mean age, 50.6 years) were enrolled in this study. Their H. pylori status was determined based on 4 tests: CLO test, culture, histology and UBT test. The H. pylori positive status was confirmed when the culture was positive, or 2 of the other 3 tests were positive. Serum samples and urine samples were collected. We used the STAT-PAK test for detecting H. pylori antibodies in serum, and read the results 24 hours later. Antibodies were also detected in urine by the RAPIRUN test, with a reading time of 25 minutes. 3 doctors read the results of both tests separately, and a positive result was determined when at least 2 of the doctors read a positive result. Results: In the STAT-PAK pretest using serum samples from 21 randomly selected patients (16 patients with H. pylori infection and 5 patients without infection), the sensitivity at 1-hour and 24-hour reading time was 18.7% and 37.5%. Specificity in both reading times was the same at 100%. Of 129 patients, 82 (64%) were H. pylori infected and 47 (36%) were uninfected. The sensitivity, specificity, and positive and negative predictive values were 31.7%, 93.6%, 89.6% and 44.0% in the STAT-PAK test with a 24-hour reading time, and 93.9%, 85.1%, 91.6%, 88.8% in the RAPIRUN test. One female was excluded because of an invalid urine test. Conclusions: The urine RAPIRUN test is a faster and more accurate office-based test than the serum STAT-PAK test for detecting the H. pylori infection in untreated patients in Taiwan. The non-invasive urine RAPIRUN test can be used as a large scale screening test for H. pylori status, particularly in children, uncooperative patients, those who have a family history of gastric cancer, or patients who can not tolerate the suffering of endoscopic examination.

Original languageEnglish
Pages (from-to)119-123
Number of pages5
JournalHepato-Gastroenterology
Volume54
Issue number73
Publication statusPublished - 2007 Jan 1

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All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Cite this

Hu, H. M., Kuo, C. H., Lo, Y. C., Wu, M. T., Wu, I. C., Lu, C. Y., Su, Y. C., Yu, F. J., Lee, Y. C., Lin, S. R., Liu, C. S., Jan, C. M., Wang, W. M., & Wu, D. C. (2007). Evaluation of the two immunochromatographic methods for detecting urine and serum IgG antibodies to Helicobacter pylori and comparison of accuracy and clinical utility. Hepato-Gastroenterology, 54(73), 119-123.