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.
Laine
L
L
Department of Medicine, USC School of Medicine, Los Angeles, California 90033, USA.
Knigge
K
K
Faigel
D
D
Margaret
N
N
Marquis
S P
SP
Vartan
G
G
Fennerty
M B
MB
D000328:Adult; D000368:Aged; D000907:Antibodies, Bacterial / Q000097:blood*; D001706:Biopsy; D001800:Blood Specimen Collection; D004724:Endoscopy; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005753:Gastric Mucosa / Q000473:pathology; D005756:Gastritis / Q000175:diagnosis* / Q000276:immunology / Q000473:pathology; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000276:immunology / Q000473:pathology; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012015:Reference Standards
D000907:Antibodies, Bacterial