Sensitivity and specificity of the hydrogen breath-analysis test for detecting malabsorption of physiological doses of lactose.

We examined the changes in sensitivity and specificity that would occur with alterations in the sample-collection schedule and (or) cutoff criterion for the increase in hydrogen concentration in breath after administration of doses of lactose in the dietary range. In a breath-analysis test to classify individuals as lactose-absorbers or lactose-malabsorbers, 41 subjects drank 360 mL of intact cow's milk, containing 18 g of lactose, and breath samples were collected and analyzed at 30-min intervals for 5 h. An increase in H2 concentration of greater than or equal to 20 microL/L above basal values at any of the 10 intervals was diagnostic of malabsorption. Increases of greater than or equal to 18 or greater than or equal to 15 microL/L were only 85% as specific in classifying the same individuals. Reduction in the number of samples tested per subject uniformly reduced the sensitivity. However, a simplified procedure suitable for field studies (in which four samples--at 0, 2, 3, and 4 h--are collected and analyzed with greater than or equal to 20 microL/L as the cutoff value) gives 80% sensitivity and 100% specificity, as compared with the 11-sample procedure.