IDkit HP One

Generic name: citric acid anhydrous and 13c urea
Dosage form: kit

IDkit Two Package Insert

Package Insert IDkit Hp™ Two for Exalenz BreathID® Hp Lab System Breath Test for Detection of H. pylori

SECTION 1. PACKAGE INSERT This package insert includes information for conducting the H. pylori test using the BreathID® Hp Lab System for analysis with the Breath Test Kit, IDkit Hp™ Two. The following are trademarks of Exalenz Bioscience Ltd.: Exalenz™, MCS™, IDkit Hp™ and BreathID®. All reference to Exalenz in this document refers to the company Exalenz Bioscience Ltd. Note: No license, expressed or implied, is granted under any patents of Exalenz Bioscience Ltd.

SECTION 2. INTENDED USE

The Exalenz BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The Exalenz BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and pediatric patients ages 3-17 years old. The Exalenz BreathID® Hp Lab System consists of the appropriate IDkit Hp™ kit and the BreathID® Hp device, Auto Sampler and Lab Application. To be administered by trained personnel as ordered by a licensed healthcare practitioner.

SECTION 3. SUMMARY AND EXPLANATION

Since the initial identification of H. pylori in the early 1980s [1], the management of upper gastrointestinal disease has changed dramatically. “Helicobacter pylori is now recognized as an important pathogen and a causal relationship between H. pylori and chronic active gastritis, duodenal ulcer, and gastric ulcer is well documented”[2]. Currently there are numerous H. pylori detection technologies for upper gastrointestinal disease including biopsy and serum analysis. These technologies depend on two general approaches for obtaining a sample for testing: invasive and non-invasive. The first invasive test method requires an endoscopic gastric biopsy. The tissue collected from the biopsy is then examined in a laboratory by microbiological culture of the organism, direct detection of urease activity in the tissue, or by histological examination of stained tissue. Biopsy-based methods present an element of patient risk and discomfort and may provide false negative results due to sampling errors. The second invasive test is a serological test; this requires a blood sample which is used to detect serum antibodies to H. pylori. The disadvantage of this test is that it is difficult to distinguish between positive active infections and past exposure to infection, and therefore it is not a conclusive indicator of current H. pylori infection. 13C-urea breath tests provide a non-invasive and non-hazardous analysis of the exhaled breath. The BreathID® test (described in the next section) measures the 12CO2 and 13CO2 components of the exhaled breath before and after the oral ingestion of 13C-enriched urea. This establishes the baseline ratio of 13CO2/12CO2 and the post ingestion ratio of 13CO2/12CO2 in order to determine the Delta Over Baseline[1] (change in the 13CO2/12CO2 ratio).

SECTION 4. PRINCIPLES OF THE EXALENZ BREATHID® BREATH TEST

The Exalenz BreathID® non-invasive breath test is a diagnostic test that analyzes a breath sample before and after ingestion of 13C-enriched urea; it is used to identify those patients with H. pylori infection. The Exalenz BreathID® breath test is performed as follows: a 75 mg 13C-urea tablet and 4.3 g Citrica Powder are dissolved in water, and the resulting solution is ingested by the patient. The presence of the Citrica creates an acidic environment in the stomach and also delays the transfer of the ing...