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Note: This “Introduction and Test Instructions” contains information for:
|Test Collection Kit||Breath Test Instrument|
UBT for H. pylori
|1. UBiT®-IR 300 Infrared Spectrophotometer|
|2. POCone™ Infrared Spectrophotometer|
The BreathTek™ UBT Collection Kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four (4) weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of CO to CO in breath samples.
For administration by health care professionals. To be administered under a physician’s supervision.
Since the isolation of the spiral urease-producing Helicobacter pylori bacteria (H. pylori) in 1983 by Drs. Marshall and Warren, a significant body of evidence has accumulated indicating that the bacteria is an important pathogen in the upper GI tract of humans. The causal relationship between H. pylori and chronic active gastritis, duodenal ulcer, and gastric ulcer is well documented. Methods available for detecting current infection of the human stomach by H. pylori are generally divided into two (2) general types: Invasive and Non-invasive.
Invasive methods are so named because they include, as a first step, an esophagogastroduodenoscopy (“EGD”) with collection of gastric biopsies. These biopsies are then examined by one or more detection methods: histological examination of stained tissue, microbiological culture of the organism, or direct detection of urease activity in the tissue (for example, the CLOtest). Biopsy based methods are expensive, entail some patient risk and discomfort and may give false negative results due to sampling errors when colonization of the gastric mucosa is patchy.
The non-invasive, non-radioactive method for detecting current H. pylori infection is based on the BreathTek™ UBT which is described in the next section. Several serological tests that detect serum antibodies to H. pylori are commercially available. A positive result with these tests cannot distinguish between current infection and past exposure to infection and, therefore, is not a conclusive indicator of current gastrointestinal colonization by H. pylori.
The BreathTek™ UBT Collection Kit should be stored at 15°-30°C (59°-86°F). Pranactin-Citric has an expiration date. Do not use beyond the expiration date stated on the label.
Note: An Infrared Spectrophotometer (UBiT-IR3000 or POCone™, Otsuka Pharmaceutical Co., Ltd.) is required for analysis of breath samples.
Complete operating information, including self-diagnostic instrument routines and user maintenance procedures, is provided in the Instruction Manuals for the UBiT-IR300 Spectrophotometer, the UBiT-AS10 Autosampler and the POCone™ Spectrophotometer, respectively. Additionally, each office laboratory or test facility should follow its own internal procedures for quality control.
Delta Over Baseline values for the BreathTek™ UBT were determined in a controlled clinical study of twenty-six (26) infected and twenty-three (23) uninfected adult volunteers. The Meretek UBT Breath Test was used as the reference method in the diagnosis of infection. The range of BreathTek™ UBT Delta Over Baseline values for the uninfected group was determined to be 0.0 to 1.0. A histogram for the distribution of Delta Over Baseline values from the uninfected subjects is shown in Figure 2a.
Values for the Meretek UBT Breath Test were determined in a controlled clinical study of sixty-six (66) infected and fifty-three (53) uninfected asymptomatic, apparently healthy volunteers. Histological examination of biopsy tissue was used as the reference method in the determination of infection in this study. The range of Meretek UBT Delta Over Baseline values for the uninfected group was determined to be 0.0 to 2.2. A histogram for the distribution of Delta Over Baseline values from the uninfected subjects is shown in Figure 2b.
The BreathTek™ UBT for H. pylori Collection Kit is manufactured for Meretek Diagnostics Group of Otsuka America Pharmaceutical, Inc., 2440 Research Boulevard, Rockville, MD 20850.
Revision: September 2008 Print Code: 0508L-0177 Part Number: 002215AC
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