A PCR protocol was developed to detect Helicobacter pylori in human stool specimens. This protocol was based on the association of a magnetic immuno-PCR assay with a technique to remove inhibitors (agaroseembedded DNA preparation). Of the 47 H. pylori-positive and 57 H. pylori-negative patients included in this study, 38 were positive and 66 were negative by this new protocol. The sensitivity, specificity, and predictive values for a positive or a negative result were 80.9% (95% confidence interval [CI], 66.3 to 90.4), 100% (95% CI, 92.1 to 100), 100% (95% CI, 88.6 to 100), and 86.4% (95% CI, 75.2 to 93.2), respectively.The high clinical relevance of Helicobacter pylori infection has stimulated the development of numerous diagnostic methods. These methods can be classified as invasive, (i.e., those that require an endoscopy to detect H. pylori directly in gastric biopsy specimens) or noninvasive (i.e., based on the study of various samples (serum, breath air, urine, etc.)), which indirectly indicate the presence of H. pylori.Stool specimens constitute a sample of easy, noninvasive access and consequently of high potential interest for the development of a direct method of H. pylori detection. PCR is a powerful technique for the detection of target DNA in various clinical specimens, but its application to stool specimens has been limited due to the presence of substances inhibiting the reaction. Numerous attempts to detect H. pylori by PCR in stool samples have been made, with controversial results ( Difficulty in eliminating PCR inhibitors from stool specimens has been extensively reported (4,5,8,12). Some authors have claimed to be successful, but usually only after applying complex procedures that are difficult to implement routinely.The aim of this study was to develop a PCR protocol to detect H. pylori in human stool specimens that is simple enough to be used routinely. For this purpose, we associated a magnetic immuno-PCR assay (MIPA) with a technique to remove inhibitors that was recently described (11).Clinical samples. One hundred four consecutive, untreated, dyspeptic patients (69 male, 35 female; mean age, 50 years; range, 17 to 87 years) who were consulting gastroenterologists for dyspepsia in Bordeaux, France, were included in the study. Exclusion criteria were as follows: H. pylori eradication treatment in the previous 6 months; consumption of antibiotics in the previous month; or consumption of antisecretory drugs, bismuth salts, or sucralfate in the previous 2 weeks. A history of coagulopathy or other disorders that are contraindications for endoscopy and/or biopsy sampling was also a reason for exclusion. For each patient, biopsies were taken for culture, histological examination, urease test (UT), and PCR. A urea breath test (UBT) and a serological test were also performed as previously described (9).A patient was classified as being H. pylori positive on the basis of (i) a positive culture; or, in the case of a negative culture, (ii) both a positive histological examination and a positive UT (C...