A Short/Rapid 13C-urea Breath Test for Helicobacter Pylori
Among the non-endoscopic procedures used in diagnosing Helicobacter pylori (H. pylori), serology remains the most accepted. It is a widely available, inexpensive test with a high negative predictive value. However, the variable specificity, especially if the prevalence of H. pylori is low, and its relatively poor positive predictive value, limit the use of the test. Carbon labeled urea breath tests (UBT), which have a high sensitivity and specificity, are commonly used as a noninvasive method in detecting an active Helicobacter pylori (H. pylori) infection. UBT are the preferred method used in epidemiological studies, screening dyspeptic patients and assessing eradication or recurrence of the infection. These tests usually entail a two point sampling with a 20 to 30-minute gap, and necessitate a mass spectrometry for analysis. Upon modifying the sampling method, immediate results can be achieved.
One such option includes real time continuous sampling C molecular correlation spectroscopy (MCS™) technology. The BreathID® device (Exalenz, Israel) has been validated and cleared by the FDA and has also been previously used on children and adults. This office-based system offers several advantages over the conventional mass spectrometry-based UBT, including an immediate test result, a standardized test drink (citric acid) and, most importantly for children, a sampling method that does not require active cooperation.
For many years, test shortening procedures have been routinely practiced including the use of various C-urea concentrations, and different citric acid test drinks. The new molecular correlation spectrometry technology enables continuous sampling of the expired breath of the patients, which in turn, enables the device to terminate the test immediately after a conclusive positive or negative result of H. pylori had been identified.
The use of a citric acid-based test drink has been shown to enhance hydrolysis of the urea and produce a more rapid rise in expired CO2. The BreathID™system combined with a citric acid drink and continuous breath sampling significantly reduces the amount of time needed for a final result compared to isotope ratio mass spectrometer. However, these test-shortening modifications have not been widely accepted by the medical community. There are limited data validating these tests but they have been in use in several gastroenterology departments for many years.
The current investigation retrospectively examined over 12,000 BreathID™ test results from several randomly selected gastroenterology departments. The goal of this retrospective evaluation was to assess, on average, the minimal time required to achieve accurate, definite UBT results using the BreathID™ system.
Background
Among the non-endoscopic procedures used in diagnosing Helicobacter pylori (H. pylori), serology remains the most accepted. It is a widely available, inexpensive test with a high negative predictive value. However, the variable specificity, especially if the prevalence of H. pylori is low, and its relatively poor positive predictive value, limit the use of the test. Carbon labeled urea breath tests (UBT), which have a high sensitivity and specificity, are commonly used as a noninvasive method in detecting an active Helicobacter pylori (H. pylori) infection. UBT are the preferred method used in epidemiological studies, screening dyspeptic patients and assessing eradication or recurrence of the infection. These tests usually entail a two point sampling with a 20 to 30-minute gap, and necessitate a mass spectrometry for analysis. Upon modifying the sampling method, immediate results can be achieved.
One such option includes real time continuous sampling C molecular correlation spectroscopy (MCS™) technology. The BreathID® device (Exalenz, Israel) has been validated and cleared by the FDA and has also been previously used on children and adults. This office-based system offers several advantages over the conventional mass spectrometry-based UBT, including an immediate test result, a standardized test drink (citric acid) and, most importantly for children, a sampling method that does not require active cooperation.
For many years, test shortening procedures have been routinely practiced including the use of various C-urea concentrations, and different citric acid test drinks. The new molecular correlation spectrometry technology enables continuous sampling of the expired breath of the patients, which in turn, enables the device to terminate the test immediately after a conclusive positive or negative result of H. pylori had been identified.
The use of a citric acid-based test drink has been shown to enhance hydrolysis of the urea and produce a more rapid rise in expired CO2. The BreathID™system combined with a citric acid drink and continuous breath sampling significantly reduces the amount of time needed for a final result compared to isotope ratio mass spectrometer. However, these test-shortening modifications have not been widely accepted by the medical community. There are limited data validating these tests but they have been in use in several gastroenterology departments for many years.
The current investigation retrospectively examined over 12,000 BreathID™ test results from several randomly selected gastroenterology departments. The goal of this retrospective evaluation was to assess, on average, the minimal time required to achieve accurate, definite UBT results using the BreathID™ system.
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