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

OBJECTIVE:Antibody testing is the recommended method to screen for Helicobacter pylori (H. pylori) infection. Whole-blood fingerstick antibody tests are simple, in-office tests providing rapid results, but the accuracy of first-generation tests was lower than other diagnostic tests. We assessed a new whole-blood antibody test, using endoscopic biopsy tests as a “gold standard,” 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 histological examination; whole-blood antibody tests and quantitative serological tests were also performed. Two separate gold standards for H. pylori infection were employed: either rapid urease test or histological exam positive; and both rapid urease test and histological exam positive.RESULTS:Sensitivities for whole-blood test versus quantitative serology with gold standard 1 (either biopsy test positive) were 86%versus 92% (95% confidence 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). Sensitivities with gold standard 2 (both biopsy tests positive) were 90%versus 94% (95% 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 widely used quantitative laboratory serological tests may be used as the initial screening tests of choice for H. pylori.