Applicability of a short/rapid 13C-urea breath test for Helicobacter pylori: retrospective multicenter chart review study

BMC Gastroenterology

Haim Shirin³  Yona Avni⁴  Eitan Skapa³  Rami Eliakim²  Vered Sehayek-Shabat¹  Hemda Schmilovitz-Weiss¹ 

[1] Gastroenterology Unit, Hasharon Hospital, Rabin Medical Center, Petach Tikva, Tel-Aviv University, Tel Aviv, Israel;Department of Gastroenterology, Rambam Medical Center, Technion, Haifa, Israel;Gastroenterology Unit, Assaf Harofeh Medical Center, Tel Aviv, Tel-Aviv University, Tel Aviv, Israel;Gastroenterology Unit, Wolfson Medical Center, Holon, Tel-Aviv University, Tel Aviv, Israel

关键词: test duration;    Helicobacter pylori;    breath test;    BreathID^®;   

Others  :  1113147
DOI  :  10.1186/1471-230X-12-8

 received in 2011-03-12, accepted in 2012-01-19,  发布年份 2012

【 摘 要 】

Background

Carbon labeled urea breath tests usually entail a two point sampling with a 20 to 30-minute gap. Our aim was to evaluate the duration of time needed for diagnosing Helicobacter pylori by the BreathID^® System.

Methods

This is a retrospective multicenter chart review study. Test location, date, delta over baseline, and duration of the entire test were recorded. Consecutively ¹³C urea breath tests results were extracted from the files over a nine year period.

Results

Of the 12,791 tests results, 35.1% were positively diagnosed and only 0.1% were inconclusive. A statistically significant difference in prevalence among the countries was found: Germany showing the lowest, 13.3%, and Israel the highest, 44.1%. Significant differences were found in time to diagnosis: a positive diagnosis had the shortest and an inconclusive result had the longest. Overall test duration averaged 15.1 minutes in Germany versus approximately 13 minutes in other countries. Diagnosis was achieved after approximately 9 minutes in Israel, Italy and Switzerland, but after 10 on average in the others. The mean delta over baseline value for a negative diagnosis was 1.03 ± 0.86, (range, 0.9 - 5), versus 20.2 ± 18.9, (range, 5.1 - 159.4) for a positive one.

Conclusions

The BreathID^® System used in diagnosing Helicobacter pylori can safely shorten test duration on average of 10-13 minutes without any loss of sensitivity or specificity and with no test lasting more than 21 minutes.

【 授权许可】

   
2012 Schmilovitz-Weiss et al; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Savarino V, Vigneri S, Celle G: The C urea breath test in the diagnosis of Helicobacter pylori infection. Gut 1999, 45(SuppI):I18-22.
• [2]Shirin H, Kenet G, Shevah O, Wardi Y, Birkenfeld S, Shahmurov M, Bruck R, Niv Y, Moss SF, Avni Y: Evaluation of a novel continuous real time 13C urea breath analyzer for Helicobacter pylori. Aliment Pharmacol Ther 2001, 15:389-394.
• [3]Levine A, Shevah O, Miloh T, Wine E, Niv Y, Bujanover Y, Avni Y, Shirin H: Validation of a novel real time 13C urea breath test for rapid evaluation of Helicobacter pylori in children and adolescents. J Pediatr 2004, 145:112-114.
• [4]Pathak CM, Bhasin DK, Nada R, Bhattacharya A, Khanduja KL: Changes in gastric enviroment with test meals affect the performance of 14C urea breath test. J Gastroenterol Hepatol 2005, 20:1260-1265.
• [5]Israeli E, Ilan Y, Meir SB, Buenavida C, Goldin E: A novel 13C-urea breath test device for the diagnosis of Helicobacter pylori infection: continuous online measurements allow for faster test results with high accuracy. J Clin Gastroenterol 2003, 37:139-141.
• [6]Urita Y, Hike K, Torii N, Kikuchi Y, Watanbe T, Kurakata H, Sugimoto M, Miki K: Ten-second endoscopic breath test using a 20-mg dose of 13C-urea to detect Helicobacter pylori infection. Hepatogastroenterology 2007, 54:951-954.
• [7]Dominguez-Munoz JE, Leodolter A, Sauerbruch T, Malfertheiner P: A citric acid solution in an optimal test drink in the 13C-urea breath test for the diagnosis of Helicobacter pylori infection. Gut 1997, 40:459-462.
• [8]Graham DY, Runke D, Anderson SY, Malaty HM, Klein PD: Citric acid as the test meal for the 13C-urea breath test. Am J Gastroenterol 1999, 94:1214-1217.
• [9]Rektorschek M, Weeks D, Sachs G, Melchers K: Influence of pH on metabolism and urease activity of Helicobacter pylori. Gastroenterology 1998, 115:628-641.
• [10]Scott DR, Weeks D, Hong C, Postius S, Melchers K, Sachs G: The role of internal urease in acid resistance of Helicobacter pylori. Gastroenterology 1998, 114:58-70.
• [11]Meyer-Rosberg K, Scott DR, Rex D, Melchers K, Sachs G: The effect of environmental pH on the proton motive force of Helicobacter pylori. Gastroenterology 1996, 111:886-900.
• [12]Weeks DL, Eskandari S, Scott DR, Sachs G: A H+ -Gated urea channel: The link between Helicobacter pylori urease and gastric colonization. Science 2000, 287:482-485.
• [13]Weil J, Bell GD, Powell K, Morden A, Harrison G, Gant PW, Jones PH, Trowell JE: Omeprazole and Helicobacter pylori: temporary suppression rather than true eradication. Aliment Pharmacol Ther 1991, 5:309-313.
• [14]Leodolter A, Dominguez-Munoz JE, Von Arnim U, Malfertheiner P: Citric acid or orange juice for the 13C-urea breath test: the impact of pH and gastric emptying. Aliment Pharmacol Ther 1999, 13:1057-1062.
• [15]Shiotani A, Saeed A, Yamaoka Y, Osato MS, Klein PD, Graham DY: Citric acid-enhanced Helicobacter pylori urease activity in vivo is unrelated to gastric emptying. Aliment Pharmacol Ther 2001, 15:1763-1767.
• [16]Agha A, Opekun AR, Abudayyeh S, Graham DY: Effect of different organic acids (citric, malic and ascorbic) on intragastric urease activity. Aliment Pharmacol Ther 2005, 21:1145-1148.
• [17]Oztürk E, Yeşilova Z, Ilgan S, Ozgüven M, Dağalp K: Performance of acidified 14C-urea capsule breath test during pantoprazole and ranitidine treatment. J Gastroenterol Hepatol 2009, 24:1248-1251.
• [18]Hamlet AK, Erlandsson KIM, Olbe L, Backman VEM, Svennerholm A-M, Pettersson AB: A simple, rapid, and highly reliable capsule-based 14C urea breath test for diagnosis of Helicobacter pylori infection. Scand J Gastroenterol 1995, 30:1058-1063.
• [19]Hamlet A, Stage L, Lönroth H, Cahlin C, Nyström C, Pettersson A: A novel tablet-based 13C urea breath test for Helicobacter pylori with enhanced performance during acid suppression therapy. Scand J Gastroenterol 1999, 34:367-374.
• [20]Chey WD, Chathadi KV, Montague J, Ahmed F, Murthy U: Intragastric acidification reduces the occurrence of false-negative urea breath test results in patients taking a proton pump inhibitor. Am J Gastroenterol 2001, 96:1028-1032.
• [21]Shirin H, Frenkel D, Shevah O, Levine A, Bruck R, Moss SF, Niv Y, Avni Y: Effect of proton pump inhibitors on the continuous real time 13C-urea breath test. Am J Gastroenterol 2003, 98:46-50.
• [22]Levine A, Shevah O, Shabat-Sehayek V, Aeed H, Boaz M, Moss SF, Niv Y, Avni Y, Shirin H: Masking of 13C urea breath test by proton pump inhibitors is dependent on type medication: comparison between omeprazole, pantoprazole, lansoprazole and esomeprazole. Aliment Pharmacol Ther 2004, 20:117-122.