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. 2025 Mar 28;13(4):767.
doi: 10.3390/microorganisms13040767.

Evaluation of the Rapid Urease Test (RUT) Device for Rapid Diagnosis of Helicobacter pylori in Middle-Aged and Elderly Taiwanese Patients

Kuan-Yi Yu  1 , Yu-Chuan Chuang  2 , Tien-Yu Huang  3 , Hua-Kang Chou  2 , Ying-Tsang Lu  4 , Juin-Hong Cherng  1   5 , Cheng-Che Liu  1   6
Affiliations

Evaluation of the Rapid Urease Test (RUT) Device for Rapid Diagnosis of Helicobacter pylori in Middle-Aged and Elderly Taiwanese Patients

Kuan-Yi Yu et al. Microorganisms. .

Abstract

The rapid urease test (RUT) is a reliable method for diagnosing Helicobacter pylori infections in endoscopy suites; however, there is a need for tests with enhanced sensitivity and faster results. This study aimed to evaluate the diagnostic performance of the new dry detection device test compared to the gel detection device and Pronto Dry RUT in detecting Helicobacter pylori infection among middle-aged and elderly Taiwanese individuals. A total of 100 participants with suspected Helicobacter pylori infection undergoing upper gastroscopy were prospectively enrolled. The dry detection device demonstrated a 99% concordance rate with the Pronto Dry RUT, with seven participants testing positive for Helicobacter pylori using both tests. In contrast, the gel detection device detected only six positive cases, highlighting the superior diagnostic sensitivity of the dry detection device. Additionally, the dry detection device produced significantly faster results than the gel detection device. These findings suggest that the dry detection device is a suitable and efficient RUT for diagnosing Helicobacter pylori in middle-aged and elderly patients. Further studies are warranted to explore its application in broader populations and clinical settings.

Keywords: Helicobacter pylori; dry detection device; gel detection device; rapid urease test.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Endoscopic gastric biopsy sampling and diagnostic process. (A) Sample collection using endoscopy by scratching the mucus layer of the stomach in zone 1 (lesser curvature) and zone 2 (greater curvature). (B) Sample preservation and labeling process.
Figure 2
Figure 2
PCR confirmation and culture results of Helicobacter pylori from gastric biopsy samples. (A) The DNA band in the PCR result confirmed the specific 16S rRNA gene of Helicobacter pylori. (B) The culture of Helicobacter pylori using blood agar. The yellow arrows indicate the locations of Helicobacter pylori colonies.
Figure 3
Figure 3
Transmission electron microscopy (TEM) images of Helicobacter pylori cultured from gastric biopsy samples. (A) The helical shape of Helicobacter pylori (showed as the red arrow in A). (B) The flagella of Helicobacter pylori (showed as red arrows in B).
Figure 4
Figure 4
Area under the ROC curve showing the predictive performance of the dry detection device versus the gel detection device model.
Figure 5
Figure 5
Positive number and sensitivity of each RUT at the different evaluated time points. (a) The number of positive diagnoses of lung cancers. (b) Corresponding sensitivities at various time points compared to Proto Dry test.
See this image and copyright information in PMC

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