PERFORMANCE OF A RAPID WHOLE-BLOOD TEST FOR HELICOBACTER-PYLORI IN PRIMARY-CARE - A GERMAN MULTICENTER STUDY

Background. Serological rapid whole-blood tests for the detection of H . pylori are presently being promoted for use in primary care. We cond ucted a multi-center study to investigate the diagnostic accuracy of t he Boehringer Mannheim Helicobacter pylori(R) test (BM test), which is identical with the Cortecs Helisal(R) test. Patients and Methods. A p revious diagnosis of H. pylori, a history of peptic ulcer diseases, or proton-pump inhibitor, bismuth or antibiotic use during the preceding month were exclusion criteria. The BM test was performed prior to end oscopy by 7 primary care physicians, 5 practicing gastroenterologists, or a single physician in the university hospital outpatient service. During endoscopy, antral and corpus biopsies were obtained for histolo gy and rapid urease testing (RUT). H. pylori positivity was defined by histology and/or RUT as reference methods. H. pylori IgG-ELISA was pe rformed additionally. Results. Of the 203 patients included, 151 were H, pylori-positive by reference methods (74.4%). The overall accuracy of the BM test was 77.3%. Eight BM tests were indeterminate, and in th e other 195 patients the test performed as follows: sensitivity 80.3%, specificity 81.3%, positive predictive value 92.9%, negative predicti ve value 57.4%. Using IgG-ELISA as reference, the BM test performance was similar. It also did not differ substantially among the three grou ps of physicians involved. Conclusions. We found the performance of th e BM test to be insufficiently accurate, as both over- and underdiagno sis of H. pylori infection were not infrequent. This test needs to be improved before its use in primary care can be recommended.