Stool antigen for the diagnosis of Helicobacter pylori infection in cirrhosis: comparative usefulness of three different methods X. CALVET*, M. QUESADA , M. ROSELLO ´ , F. SALCEDA , I. SANFELIU , B. DALMAU* & M. GIL* *Unitat de Malalties Digestives and Laboratori de Microbiologia, Corporacio ´ Parc Taulı ´, Sabadell, Barcelona, Spain Accepted for publication 30 November 2002 SUMMARY Background: Helicobacter pylori infection may lead to peptic ulcer disease, and causes significant morbidity in patients with cirrhosis. The measurement of H. pylori antigens in human stools has been proposed as a valuable, non-invasive, diagnostic tool. A number of tests have recently been commercialized. However, very few data are available on their reliability in patients with cirrhosis. Aim: To evaluate the usefulness of three new tests — HpSA (Meridian Diagnostics Inc., Cincinnati, OH, USA), Simple H. pyl (OPERON S.A., Zaragoza, Spain) and FemtoLab H. pylori (Connex, Martinsried, Germany) — in the diagnosis of H. pylori infection in cirrhotic patients. Methods: H. pylori infection was determined in 79 cirrhotic patients (48 men, 31 women; age range, 29– 82 years; mean, 62 ± 11 years) by concordance of histology and urea breath test. The sensitivity, specifi- city and positive and negative predictive values of each stool test were calculated. Results: According to the reference method, the sensi- tivities of HpSA, Simple H. pyl and FemtoLab H. pylori immunoassays were 76%, 87% and 78%, respectively, and their specificities were 93%, 62% and 79%, respectively. Conclusions: Faecal tests are non-invasive and easy-to- perform tools for the diagnosis of H. pylori infection. However, their sensitivity and specificity seem to be non-optimal in patients with cirrhosis. INTRODUCTION Peptic ulcer is a frequent finding in cirrhotic patients, and its complications result in significant morbidity and mortality. 1 Helicobacter pylori infection is the major cause of peptic ulcer in both cirrhotics and the general population. 2, 3 Although there are no data on cirrhotic patients, the eradication of H. pylori infection would probably lead to the almost total prevention of recurrent peptic ulcer and its complications, as it does in non- cirrhotic individuals. 4–7 In addition, H. pylori may also increase the risk of hepatic encephalopathy, although this topic remains extremely controversial. 8–12 There- fore, the correct diagnosis and treatment of H. pylori infection is important in patients with liver cirrhosis and peptic ulcer. The search for an ideal test to diagnose H. pylori infection has been only partially successful. The perfect test would be highly reliable, inexpensive and non- invasive. Until recently, serology and the 13 C-urea breath test were the only non-invasive tests available. However, the inaccuracy of serology has led recent consensus reports to advise against its general use. 13 In contrast, the 13 C-urea breath test is very sensitive and specific, but expensive, as it usually requires trained personnel to obtain the breath samples, and both 13 C-urea and the instrumentation necessary to interpret the samples are costly. 14 Recently, it has been reported that H. pylori antigens can be measured in human stools. The stool test may become a valuable, non-invasive, diagnostic tool. Three new tests have been commercialized: Premier Platinum Correspondence to: Dr X. Calvet, Unitat de Malalties Digestives, Corporacio ´ Parc Taulı ´, Parc Taulı ´, s/n, 08208 Sabadell, Barcelona, Spain. E-mail: xcalvet@cspt.es Aliment Pharmacol Ther 2003; 17: 727–731. doi: 10.1046/j.0269-2813.2003.01466.x Ó 2003 Blackwell Publishing Ltd 727