Skip to main content

Advertisement

Log in

A new, practical, low-dose 14C-urea breath test for the diagnosis of Helicobacter pylori infection: clinical validation and comparison with the standard method

  • Original Article
  • Published:
European Journal of Nuclear Medicine and Molecular Imaging Aims and scope Submit manuscript

Abstract

The carbon-14 urea breath test (UBT) is a reliable and non-invasive technique for the diagnosis of Helicobacter pylori (HP) infection. In this study we evaluated the diagnostic performance of a new, practical and low-dose 14C-UBT system for the diagnosis of HP and compared the results with those obtained using the standard method. Seventy-five patients (56 female, 19 male) with dyspepsia underwent 14C-UBT and endoscopy with antral biopsies for histological analysis. The rapid urease test (CLO test) was applied to 50 of these patients. After a 6-h fasting period, a 37-kBq 14C-urea capsule was swallowed for UBT. Breath samples were collected and counted using two different methods, the Heliprobe method and the standard method. In the Heliprobe method, patients exhaled into a special dry cartridge system (Heliprobe BreathCard) at 10 min. The activities of the cartridges were counted using a designated small GM counter system (Heliprobe analyser). Results were expressed both as counts per minute (HCPM) and as grade (0, not infected; 1, equivocal; 2, infected) according to the counts. In the standard method, breath samples were collected by trapping in a liquid CO2 absorber. Radioactivity was counted as disintegrations per minute (SDPM) using a liquid scintillation counter after addition of a liquid scintillation cocktail. Histological examination was used as a gold standard. Two patients were excluded from the study because of inadequate biopsy sampling. Forty-eight patients (65%) were found to be HP positive on histology. The Heliprobe method correctly classified 48 of 48 HP-positive patients and 19 of 25 HP-negative patients (sensitivity 100%, specificity 76%, PPV 88%, NPV 100%, accuracy 91%). The standard method correctly classified 48 of 48 HP-positive patients and 20 of 25 HP-negative patients (sensitivity 100%, specificity 80%, PPV 90%, NPV 100%, accuracy 93%). On the other hand, the CLO test identified 26 of 32 HP-positive and 12 of 16 HP-negative patients (sensitivity 81%, specificity 75%, PPV 86%, NPV 66%, accuracy 79%). With the Heliprobe method, all of the positive results were grade 2, and all of the negative results were grade 0. No patients were defined as having grade 1 results. Counts allowed clear discrimination of HP-positive and -negative patients with both methods, the difference being statistically significant in each case (P<0.001). A significant correlation was found between HCPM and SDPM (r 0.863, P<0.001). According to the ROC analysis, the area under the curve was nearly the same with HCPM (AUC, 0.888; 95% CI, 0.785–0.992) and SDPM (AUC, 0.898; 95% CI, 0.802–0.994). In conclusion, the new 14C-UBT system is a highly accurate method for the diagnosis of HP infection. It is rapid and practical, and therefore suitable for clinical and office practice.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1.
Fig. 2.

Similar content being viewed by others

References

  1. Desroches JJ, Lahaie RG, Picard M, Morais J, Dumont A, Gaudreau C, Picard D, Chartrand R. Methodological validation and clinical usefulness of carbon-14-urea breath test for documentation of presence and eradication of Helicobacter pylori infection. J Nucl Med 1997; 38:1141–1145.

    CAS  PubMed  Google Scholar 

  2. Reilly TG, Poxon V, Sanders DSA, Elliott TSJ, Walt RP. Comparison of serum, salivary and rapid whole blood diagnostic tests for Helicobacter pylori and their validation against endoscopy based tests. Gut 1997; 40:454–458.

    CAS  PubMed  Google Scholar 

  3. Sipponen P, Hyvarinen H. Role of Helicobacter pylori in the pathogenesis of gastritis, peptic ulcer and gastric cancer. Scand J Gastroenterol 1993; 28 Suppl 196:3–6.

    Google Scholar 

  4. Newell DG, Hawtin PR, Stacey AR, MacDougall MH, Ruddle AC. Estimation of prevalence of Helicobacter pylori infection in an asymptomatic elderly population comparing [14C] urea breath test and serology. J Clin Pathol 1991; 44:385–387.

    CAS  PubMed  Google Scholar 

  5. Thijs JC, Van Zwet AA, Thijs WJ, Oey HB, Karrenbeld A, Stellaard F, Luijt DS, Meyer BC, Kleibeuker JH. Diagnostic tests for Helicobacter pylori: a prospective evaluation of their accuracy, without selecting a single test as the gold standard. Am J Gastroenterol 1996; 91:2125–2129.

    PubMed  Google Scholar 

  6. Peura DA, Pambianco DJ, Dye KR, Lind C, Frierson HF, Hoffman SR, Combs MJ, Guilfoyle E, Marshall BJ. Microdose14C-urea breath test offers diagnosis of Helicobacter pylori in 10 minutes. Am J Gastroenterol 1996; 91:233–238.

    CAS  PubMed  Google Scholar 

  7. Raju GS, Smith MJ, Morton D, Bardhan KD. Mini-dose (1-microCi)14C-urea breath test for the detection of Helicobacter pylori. Am J Gastroenterol 1994; 89:1027–1031.

    CAS  PubMed  Google Scholar 

  8. Hamlet AK, Erlandsson KI, Olbe L, Svennerholm AM, Backman VE, Pettersson AB. A simple, rapid, and highly reliable capsule-based14C urea breath test for diagnosis of Helicobacter pylori infection. Scand J Gastroenterol 1995; 30:1058–1063.

    CAS  PubMed  Google Scholar 

  9. Ahuja V, Bal CS, Sharma MP. Can the C-14 urea breath test replace follow-up endoscopic biopsies in patients treated for Helicobacter pylori infection? Clin Nucl Med 1998; 25:815–819.

    Article  Google Scholar 

  10. Andersen LP, Kiilerick S, Pedersen G, Thoreson AC, Jorgensen F, Rath J, Larsen NE, Borup O, Krogfelt K, Scheibel J, Rune S. An analysis of seven different methods to diagnose Helicobacter pylori infections. Scand J Gastroenterol 1998; 33:24–30.

    Article  CAS  PubMed  Google Scholar 

  11. Morris A, Ali MR, Brown P, Lane M, Patton K. Campylobacter pylori infection in biopsy specimens of gastric antrum: laboratory diagnosis and estimation of sampling error. J Clin Pathol 1989; 42:727–732.

    CAS  PubMed  Google Scholar 

  12. Christensen AH, Gjorup T, Hilden J, Fenger C, Henriksen B, Vyberg M, Ostergaard K, Hansen BF. Observer homogeneity in the histologic diagnosis of Helicobacter pylori: latent class analysis, kappa coefficient and repeat frequency. Scand J Gastroenterol 1992; 27:933–939.

    CAS  PubMed  Google Scholar 

  13. MacOni G, Vago L, Galletta G, Imbesi V, Sangaletti O, Parente F, Cucino C, Bonetto S, Porro GB. Is routine histological evaluation an accurate test for Helicobacter pylori infection? Aliment Pharmacol Ther 1999; 13:327–331.

    Article  CAS  PubMed  Google Scholar 

  14. Henze E, Malfertheiner P, Clausen M, Burkhardt H, Adam WE. Validation of a simplified carbon-14-urea breath test for routine use for detecting Helicobacter pylori noninvasively. J Nucl Med 1990; 31:1940–1944.

    CAS  PubMed  Google Scholar 

  15. Veldhuyzen van Zanten SJ, Tytgat KM, Hollingsworth J, Jalali S, Rshid FA, Bowen BM, Goldie J, Goodacre RL, Riddell RH, Hunt RH.14C-urea breath test for the detection of Helicobacter pylori. Am J Gastroenterol 1990; 85:399–403.

    PubMed  Google Scholar 

  16. Pathak CM, Panigrahi D, Bhasin DK, Rana SV, Malik AK, Mehta SK. Advantage of use of DPM for14C-urea breath test for the detection of Helicobacter pylori. Am J Gastroenterol 1992; 87:1887–1888.

    CAS  PubMed  Google Scholar 

  17. Laine L, Estrada R, Trujillo M, Knigge K, Fennerty MB. Effect of proton-pump inhibitor therapy on diagnostic testing for Helicobacter pylori. Ann Intern Med 1998; 129:547–550.

    CAS  PubMed  Google Scholar 

  18. Bravo LE, Realpe JL, Campo C, Mera R, Correa P. Effects of acid suppression and bismuth medications on the performance of diagnostic tests for Helicobacter pylori infection. Am J Gastroenterol 1999; 94:2380–2383.

    Article  CAS  PubMed  Google Scholar 

  19. Chey WD, Woods M, Scheiman JM, Nostrant TT, DelValle J. Lansoprazole and ranitidine affect the accuracy of the14C-urea breath test by a pH-dependent mechanism. Am J Gastroenterol 1997; 92:446–450.

    CAS  PubMed  Google Scholar 

  20. Chey WD, Chathadi KV, Montague J, et al. Intragastric acidification reduces occurrence of false-negative urea breath test results in patients taking a proton pump inhibitor. Am J Gastroenterol 2001; 96:1028–1032.

    Article  CAS  PubMed  Google Scholar 

  21. Stubbs JB, Marshall B. Radiation dose estimates for the carbon-14-labeled urea breath test. J Nucl Med 1993; 34:821–825.

    CAS  PubMed  Google Scholar 

  22. Leide-Svegborn S, Stenstrom K, Olofsson M, Mattsson S, Nilsson LE, Nosslin B, Pau K, Johansson L, Erlandsson B, Hellborg R, Skog G. Biokinetics and radiation doses for carbon-14 urea in adults and children undergoing the Helicobacter pylori breath test. Eur J Nucl Med 1999; 26:573–580.

    Article  CAS  PubMed  Google Scholar 

  23. Boivin C.13C-urea versus 14C-urea breath test—which is the safer? Nucl Med Commun 1999; 20:978.

    CAS  PubMed  Google Scholar 

  24. Nuclear Radioactive Committee, USA, 10 CFR §30.21. Radioactive drug: capsules containing carbon-14 urea for "in vivo" diagnostic use for humans.

Download references

Acknowledgements

The authors are grateful to Assoc. Prof. Muhittin Serdar for help with statistical analysis of the data.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Emel Öztürk.

Additional information

Part of this work was presented at the 15th Congress of the European Association of Nuclear Medicine, held on 31 August to 4 September 2002 in Vienna, Austria.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Öztürk, E., Yeşilova, Z., Ilgan, S. et al. A new, practical, low-dose 14C-urea breath test for the diagnosis of Helicobacter pylori infection: clinical validation and comparison with the standard method. Eur J Nucl Med Mol Imaging 30, 1457–1462 (2003). https://doi.org/10.1007/s00259-003-1244-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00259-003-1244-8

Keywords

Navigation