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H elicobacter Pylori Breath Testing in an Open Access System has a High Rate of Potentially False Negative Results due to Protocol Violations
Author(s) -
Olafsson Snorri,
Patel Bhaveshkumar,
Jackson Christian,
Cai Jin
Publication year - 2012
Publication title -
helicobacter
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 79
eISSN - 1523-5378
pISSN - 1083-4389
DOI - 10.1111/j.1523-5378.2012.00964.x
Subject(s) - urea breath test , helicobacter pylori , medicine , false negative reactions , breath test , false positive rate , proton pump inhibitor , gastroenterology , helicobacter pylori infection , statistics , mathematics
Background Among available tests to detect H elicobacter pylori ( H . pylori ), urea breath test ( UBT ) is the most accurate when performed correctly in research protocols with unknown validity in clinic settings. Material and Methods A total of 595 subjects at a gastroenterology clinic were tested 620 times with UBT . Detailed information about three known factors (recent proton‐pump inhibitors ( PPI ), antibiotics, or bismuth, H . pylori eradication treatment finished <4 weeks ago, and gastric resection) to make UBT unreliable were prospectively recorded before each test. Results Twenty‐three percent (120 of 526) of all negative tests fell in one or more of the three categories, which had the potential to make UBT unreliable. Of those carried out on persons without being treated before, the potential false negative rate was 15%. Among those with previous eradication treatment, the rate was around 45%. Conclusions If a negative UBT could be false negative in up to 23% of cases, then it has a serious lack of negative predictive value. A negative UBT should be considered false negative until potential protocol violations are excluded.