Quantification of Helicobacter pylori infection: Simple and rapid 13 C-urea breath test in Taiwan

Abstract

The 13C-urea breath test (13C-UBT) is a non-invasive method for detecting Helicobacter pylori. This study was performed to determine the cutoff value and evaluate the sensitivity and specificity of 13C-UBT in Taiwan. 13C-Urea (100 mg of 99% 13C-labeled urea) was dissolved in 50 ml sterile water for the test. The test meal for delaying gastric emptying was 100 ml fresh milk. Patients fasted for at least 6h. A baseline breath sample was collected 5 min after they had the test meal. Two other samples were collected at 15 and 30 min after the patients ingested the 13C-urea. The test was evaluated in 352 patients after routine upper gastrointestinal endoscopy, and the urease test, culture, and histopathology were taken as the gold standards for detecting H. pylori. According to the receiver operating characteristic (ROC) curves, we chose values of 2.8 and 4.2 excess delta 13CO2 per mil as the cut-off values for 15 and 30 min, respectively, post 13C-urea. The sensitivity and specificity of 13C-UBT were 99% and 93% at 15 min, and 98% and 93% at 30 min post 13C-urea, respectively. The 13C-UBT breath test is an efficient non-invasive method of high sensitivity and high specificity for detecting H. pylori infection. We suggest that the use of fresh milk as the test meal and the detection of excess delta 13CO2 15 min after the ingestion of 13C-urea are suitable for the clinical use of 13C-UBT. This test is simple and rapid.

Comparison of the Clinical Feasibility of Three Rapid Urease Tests in the Diagnosis of Helicobacter pylori Infection

“…One hundred milliliters of fresh milk was used as the test meal. This procedure was modified from our previous study (8). All samples were sent to INER, where a continuous-flow isotope ratio mass spectrometer (CF-IRMS) (Europa Scientific Ltd, Crewe, UK) was used for analysis.…”

The 13C‐urea breath test to detect Helicobacter pylori infection: a validated simple methodology with 50 mg 13C‐urea

“…The U 100 of conventional 13 C-UBT has been proven to possess good sensitivity (97%) and specificity (95%) in Taiwan. 14 On the second or third day after endoscopy, breath tests were repeated with a low dose of 50 mg 13 C-urea (U 50 ) after an overnight fast. The breath samples were collected at baseline and at 10 (protocol t 10 ), 15 (protocol t 15 ) and 30 min (protocol t 30 ) after the ingestion of 13 …”

“…The appearance of labelled carbon dioxide in the breath indicates that infection is present. Although 14 C can be used for the same purpose, 3, 4 13 C has the advantage of being non-radioactive and can safely be used in children and women of child-bearing age.…”

“…Several papers describing the methodology of 13 C-UBT have been published, [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20] but they differ with regard to the dose of 13 C-urea, timing of the sample collection, type of test meal used and the equipment required to analyse the breath samples. However, only the dose of 13 C-urea and the measuring equipment are directly related to the costs of the test.…”

An optimized13C-urea breath test for the diagnosis ofH pyloriinfection

“…Through the years there have been numerous modifications to the test meal, including the use of citric acid alone before administering the urea [37,62,67,79,84,85,97] , or mixed with the 13 C-urea at the time of administration [43][44][45]88,91,98] , or as a presentation in combination with the 13 C-urea [42,61,72,94,99] . Several alternatives to citric acid have also been tested, including orange juice [43,49,67,90,95] and apple juice [100] , as well as other types of food such as milk [48,58,101,102] and a pudding test meal [34,46] , and even water [41,103] . As shown in Table 3, the majority of the test meals have provided reliable results.…”