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The Pylori-Chek Test System is intended for use with the LARA Laser Assisted Ratio Analyzer for the qualitative detection of urease associated with Helicobacter pylori infection in the human stomach and as an aid in the diagnosis of H. pylori infection in symptomatic adult patients. The Pylori-Chek Test system consists of a Pylori-Chek test kit for the collection of breath samples and a LARA Laser Assisted Ratio Analyzer for the measurement of the ratio of 13CO2 to 12CO2 in the breath sample. For use by healthcare professionals. To be administered under a physician's supervision.

The Alimenterics LARA Breath Test System is comprised of two components: (1) the Pylori-Chek Breath Test Kit; and (2) the LARATM (Laser Assisted Ratio Analyzer) System The Alimenterics LARA Breath Test System is based on the ability of the H.pylori organism to produce large amounts of the enzyme urease, which hydrolyses urea to NHL and CO3, the latter being exhaled. Using 30-labeled urea, an increase in the ratio of 130, to "CO, over time is an indication for the presence of H. pylori. This change can be detected by the LARA System based on a comparison of pre- and post-ingestion measurements of the patient's breath. The Alimenterics breath test procedure involves a pre-ingestion analysis of a sample of the patient's breath to determine the baseline ratios of '30, to '200, Following ingestion of a test meal and 100 mg 13C-labeled urea, breath samples are collected at thirty and sixty minutes thereafter. The samples are then introduced into the LARA analyzer which, based on the laser optogalvanic effect, measures the ratio of 13CO2 to 12CO2 The results of the three readings, with respect to a calibration standard, are determined concurrently by the analyzer. A specified change in the ratio of 13CO2 to 12CO2 in the 30 or 60 minute samples as compared to the baseline sample constitutes a positive test. Test values are generated and a report is printed for each patient.