title: Selection of a cut-off for high- and low-methane producers using a spot-methane breath test: results from a large north American dataset of hydrogen, methane and carbon dioxide measurements in breath.
abstract: Levels of breath methane, together with breath hydrogen, are determined by means of repeated collections of both, following ingestion of a carbohydrate substrate, at 15-20 minutes intervals, until 10 samples have been obtained. The frequent sampling is required to capture a rise of hydrogen emissions, which typically occur later in the test: in contrast, methane levels are typically elevated at baseline. If methane emissions represent the principal objective of the test, a spot methane test (i.e. a single-time-point sample taken after an overnight fast without administration of substrate) may be sufficient.
  
  
  
  We analysed 10-sample lactulose breath test data from 11 674 consecutive unique subjects who submitted samples to Commonwealth Laboratories (Salem, MA, USA) from sites in all of the states of the USA over a one-year period. The North American Consensus (NAC) guidelines criteria for breath testing served as a reference standard.
  
  
  
  The overall prevalence of methane-positive subjects (by NAC criteria) was 20.4%, based on corrected methane results, and 18.9% based on raw data. In our USA dataset, the optimal cut-off level to maximize sensitivity and specificity was ≥4 ppm CH4, 94.5% [confidential interval (CI): 93.5-95.4%] and 95.0% (CI: 94.6-95.5%), respectively. The use of a correction factor (CF) (5% CO2as numerator) led to reclassifications CH4-high to CH4-low in 0.7 % and CH4-low to CH4-high in 2.1%.
  
  
  
  A cut-off value for methane at baseline of either ≥4 ppm, as in our USA dataset, or ≥ 5 ppm, as described in a single institution study, are both highly accurate in identifying subjects at baseline that would be diagnosed as 'methane-positive' in a 10-sample lactulose breath test for small intestinal bacterial overgrowth.
authors.affiliation: Synthetic Biologics Inc., Rockville, Maryland, USA kgottlieb@syntheticbiologics.com.
authors.forename: Klaus
authors.initials: K
authors.lastname: Gottlieb
authors.affiliation: Synthetic Biologics Inc., Rockville, Maryland, USA.
authors.forename: Chenxiong
authors.initials: C
authors.lastname: Le
authors.affiliation: Synthetic Biologics Inc., Rockville, Maryland, USA.
authors.forename: Vince
authors.initials: V
authors.lastname: Wacher
authors.affiliation: Synthetic Biologics Inc., Rockville, Maryland, USA.
authors.forename: Joe
authors.initials: J
authors.lastname: Sliman
authors.affiliation: Commonwealth Laboratories LLC, Salem, Massachusetts, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Cruz
authors.affiliation: Commonwealth Laboratories LLC, Salem, Massachusetts, USA.
authors.forename: Tyler
authors.initials: T
authors.lastname: Porter
authors.affiliation: Commonwealth Laboratories LLC, Salem, Massachusetts, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Carter
keywords: breath tests; diagnostic test; small intestinal bacterial overgrowth; spot-methane breath test