13C-Urea breath test, using a new compact nondispersive isotope-selective infrared spectrophotometer: comparison with mass spectrometry.
BACKGROUND
The (13)C-urea breath test ((13)C-UBT) is the most commonly used noninvasive method of detecting Helicobacter pylori infection. The isotope ratio mass spectrometer (IRMS) is the most commonly used device for this test, but the UBiT-IR300 infrared spectrophotometer, which, by comparison, is a more compact, less expensive, and easier to use analytical device, has now become widely used in the clinical setting in Japan. The objective of this study was to examine the diagnostic performance of the (13)C-UBT, using the UBiT-IR300.


METHODS
A multicenter open-label study was performed, in which the (13)C-UBT was conducted using 100 mg of (13)C-urea. Analysis of (13)CO(2) in the expired breath was performed by infrared spectroscopy and mass spectrometry, and assessment of H. pylori infection was performed by culture, histological examination, and rapid urease test.


RESULTS
In 255 cases of H. pylori infection diagnosed by biopsy methods, the (13)C-UBTs, performed with two different (13)C-ruea formulations, and using infrared spectroscopy for evaluation, showed a sensitivity of 97.7%, specificity of 98.0%, and accuracy of 97.8% (total number of evaluable cases, n = 505). The rate of agreement in the assessment of H. pylori infection between infrared spectroscopy and mass spectrometry was 100% ( n = 505). The regression equation for infrared spectroscopy to mass spectrometry was y = 0.9822x - 0.0809 ( n = 2542), with a correlation coefficient of r = 0.99989 ( P = 0.0001).


CONCLUSIONS
Diagnosis of H. pylori infection can be performed using infrared spectroscopy as well as mass spectrometry.
Division of Endoscopy, Hokkaido University Hospital, North 14, West 5, Kita-ku, Sapporo 060-8648, Japan.
Mototsugu
M
Kato
Masao
M
Saito
Shinsaku
S
Fukuda
Chieko
C
Kato
Shuichi
S
Ohara
Shiro
S
Hamada
Ryuichi
R
Nagashima
Katsutoshi
K
Obara
Masayuki
M
Suzuki
Hirohito
H
Honda
Masahiro
M
Asaka
Takakane
T
Toyota
D001944:Breath Tests; D002247:Carbon Isotopes; D018592:Cross-Over Studies; D005767:Gastrointestinal Diseases / Q000175:diagnosis / Q000382:microbiology*; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori; D006801:Humans; D013058:Mass Spectrometry; D012680:Sensitivity and Specificity; D013055:Spectrophotometry, Infrared; D014508:Urea
D002247:Carbon Isotopes; D014508:Urea