Fingerstick Helicobacter pylori antibody test: Better than laboratory serological testing?

OBJECTIVE: Antibody testing is the recommended method to screen for Helicob acter pylori (H. pylori) infection. Whole-blood fingerstick antibody tests are simple, in-office tests providing rapid results, but the accuracy of fi rst-generation tests was lower than other diagnostic tests. We assessed a n ew whole-blood antibody test, using endoscopic biopsy tests as a "gold stan dard," and compared it with a laboratory quantitative serological test. METHODS: Two hundred-one patients not previously treated for H. pylori who were undergoing endoscopy had gastric biopsies for rapid urease test and hi stological examination; whole-blood antibody tests and quantitative serolog ical tests were also performed. Two separate gold standards for H. pylori i nfection were employed: either rapid urease test or histological exam posit ive; and both rapid urease test and histological exam positive. RESULTS: Sensitivities for whole-blood test versus quantitative serology wi th gold standard 1 (either biopsy test positive) were 86% versus 92% (95% c onfidence interval [CI] of difference, -2-14%; p = 0.19) and specificities were 88% versus 77% (95% CI of difference, 0.4-22%; p = 0.052). Sensitiviti es with gold standard 2 (both biopsy tests positive) were 90% versus 94% (9 5% CI of difference, -4-12%; p = 0.41) and specificities were 79% versus 67 % (95% CI of difference, 1-24%; p = 0.048). CONCLUSIONS: New generation in-office, whole-blood antibody tests that can achieve a sensitivity and specificity similar to or better than those of wi dely used quantitative laboratory serological tests may be used as the init ial screening tests of choice for H. pylori. (Am J Gastroenterol 1999;94:34 64-3467. (C) 1999 by Am. Coll. of Gastroenterology).