evaluation of gastrolyzer clinical paper

EVALUATION OF THE ACCURACY OF A PORTABLE DEVICE, GASTROLYZER EC60 BEDFONT, FOR HYDROGEN (H2) DETECTION IN EXPIRED AIR Di Stefano M, Missanelli A, Miceli E, Mazzocchi S, Corazza GR. Gastroenterology Unit, IRCCS Policlinico S. Matteo, University of Pavia, Pavia; Italy. Background and Aims: H 2 Breath Test (H 2 BT) is a simple, noninvasive, repeatable and cheap test for diagnosis of carbohydrate malabsorption. Recently, a portable device, Gastrolyzer EC60 Bedfont, was proposed for detection of H 2 in expired air, but until now there were no studies which evaluated its accuracy. Patients and Methods: 32 patients (20 female, mean age 40±16 yrs) with functional bowel complaints, who underwent H 2 - breath test as a part of their diagnostic algorithm, took part in this study. Fifteen of them underwent H 2 BT after lactose due to lactose malabsorption, 9 after glucose due to small bowel bacterial overgrowth, 8 after lactulose for an evaluation of cumulative H 2 production capacity. In each breath sample, H 2 levels were measured with the new device and with the conventional instrument, Quintron Microlyzer DP 12, considered the gold standard. Lactose breath test was positive if an increase >20ppm over baseline was present. Glucose breath test was positive if an increase >12 ppm over baseline was present. Cumulative H 2 production capacity was considered elevated if the area under the time-concentration curve (AUC) was >5000 ppm x min. Statistical analysis was performed by the Bland and Altman graphical method and by the Lin’s concordance correlation coefficient. The Kappa statistics were calculated to evaluate the agreement between the two methods in terms of test positivity. Results: The concordance calculated with the Lin’s correlation coefficient was 97,2% with a confidence gap between 95 and 99%. The agreement between the positivity/negativity of the lactose and glucose tests was 100% (Kappa). The repeatability for the AUC (Bland and Altman) was estimated around 98,5% with a uniform distribution of the data. Conclusions: The gastrolyzer is a very accurate device. Due to a simple and quick procedure for breath collection, it can be used in any location, allowing a prolonged, ambulatory measurement of breath H 2 excretion. The adoption of recently described, more accurate diagnostic criteria for carbohydrate malabsorption, based on a 7-hour measurement of breath H 2 excretion could be easier using such a portable device. 95% Limits Of Agreement Difference of lnauc_quintronandlnauc_bedfont Mean o f lnauc_qui ntron and lnauc_bed font 4 6 8 10 -1 0 1 2 Note: Data must overlay dashed line for perfect concordance lnauc_quintron ln au c_ be dfo nt 4 6 8 10 4 6 8 10 Concordance calculated with the Lin’s correlation coefficent Repeatability for the AUC performed by the Bland and Altman graphical method

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An analysis of Bedfont Scientific's handheld Gasto+ EC60 hydrogen breath monitor, compared with the non-portable Quintron Microlyzer DP, finds Bedfont's device to have a high degree of accuracy.

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Page 1: Evaluation of Gastrolyzer Clinical Paper

EVALUATION OF THE ACCURACY OF A PORTABLE DEVICE, GASTROLYZER EC60 BEDFONT, FOR HYDROGEN (H2) DETECTION IN EXPIRED AIR

Di Stefano M, Missanelli A, Miceli E, Mazzocchi S, Corazza GR.Gastroenterology Unit, IRCCS Policlinico S. Matteo, University of Pavia, Pavia; Italy.

Background and Aims: H2 Breath Test (H2BT) is a simple, noninvasive, repeatable and cheap test for diagnosis of carbohydrate malabsorption. Recently, a portable device, Gastrolyzer EC60 Bedfont, was proposed for detection of H2 in expired air, but until now there were no studies which evaluated its accuracy.

Patients and Methods: 32 patients (20 female, mean age 40±16 yrs) with functional bowel complaints, who underwent H2-breath test as a part of their diagnostic algorithm, took part in this study. Fifteen of them underwent H2BT after lactose due to lactose malabsorption, 9 after glucose due to small bowel bacterial overgrowth, 8 after lactulose for an evaluation of cumulative H2 production capacity. In each breath sample, H2 levels were measured with the new device and with the conventional instrument, Quintron Microlyzer DP 12, considered the gold standard. Lactose breath test was positive if an increase >20ppm over baseline was present. Glucose breath test was positive if an increase >12 ppm over baseline was present. Cumulative H2 production capacity was considered elevated if the area under the time-concentration curve (AUC) was >5000 ppm x min. Statistical analysis was performed by the Bland and Altman graphical method and by the Lin’sconcordance correlation coefficient. The Kappa statistics were calculated to evaluate the agreement between the two methods in terms of test positivity.

Results: The concordance calculated with the Lin’s correlation coefficient was 97,2% with a confidence gap between 95 and 99%. The agreement between the positivity/negativity of the lactose and glucose tests was 100% (Kappa). The repeatability for the AUC (Bland and Altman) was estimated around 98,5% with a uniform distribution of the data.

Conclusions: The gastrolyzer is a very accurate device. Due to a simple and quick procedure for breath collection, it can be used in any location, allowing a prolonged, ambulatory measurement of breath H2 excretion. The adoption of recently described, more accurate diagnostic criteria for carbohydrate malabsorption, based on a 7-hour measurement of breath H2 excretion could be easier using such a portable device.

95% Limits Of Agreement

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Mean of lnauc_quintron and lnauc_bedfont4 6 8 10