Noninvasive antigen-based assay for assessing Helicobacter pylori eradication: a European multicenter study. The European Helicobacter pylori HpSA Study Group.

摘要: OBJECTIVE: In a recently published multicenter study involving 501 patients undergoing esophagogastroduodenoscopy (EGD) throughout Europe, we showed the high accuracy of developed simple test (HpSA) to detect Helicobacter pylori (H. pylori) antigens in stools untreated patients. The aim this was assess diagnostic usefulness HpSA compared with 13C UBT shortly after H. eradication treatment. METHODS: Of enrolled validation study, 279 were found be pylori-positive. These given eradicating regimen and asked return for follow-up EGD biopsies, testing 4 wk therapy. Follow-up results available 235 these, 162 consented all 73 only testing. We assessed sensitivity specificity both biopsy-based methods patients, who accepted EGD. also UBT, arbitrarily chosen as gold standard, whole population RESULTS: Sensitivity second 93.8% (CI: 85.4-100%) 96.9% 93.9-99.9%) HpSA, 90.6% 80.5-100%) 99.2% 97.7-100%) UBT. Using EGD-based 130 treated patients' infection eradicated (125 HpSA-negative, one borderline, four false-positive; 129 UBT-negative, false-positive), 32 remained pylori-infected (30 HpSA-positive, two false-negative, 29 UBT-positive, three false negative). overall rate 80.2%. relative standard (n = 235) 95.6% 89.6-100%) 94.7% 91.5-97.9%), respectively. CONCLUSIONS: has proven useful method posttreatment pylori. Its ease use, speed, noninvasive nature make an ideal post-treatment monitoring where may not justified.