A Novel Real-Time Visual Diagnostic Method for Helicobacter pylori Based on Fluorescence ROSE: A Large-Sample Controlled Study Using Latent Class Analysis Without a Gold

Corresponding author: Zhanglin, stepinghuns2@163.com

DOI: 10.12201/bmr.202606.00055

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  Abstract: Objective This study aimed to compare the diagnostic performance of five detection methods for Helicobacter pylori (Hp) infection—fluorescence rapid on‑site evaluation (F‑ROSE), conventional histopathological examination (hematoxylin‑eosin staining/Giemsa staining), urea breath test (UBT), rapid urease test (RUT), and endoscopic white‑light visual assessment—under the assumption of no gold standard. Using large‑sample clinical data, we sought to demonstrate the diagnostic advantages of F‑ROSE and validate its clinical utility. Methods A total of 317 patients with suspected Hp infection were prospectively enrolled. All five tests were performed synchronously in a blinded manner during the same visit: F‑ROSE, conventional histopathology (HE/Giemsa), UBT, RUT, and endoscopic white‑light visual assessment. A no‑gold‑standard evaluation framework was adopted: (1) inter‑method agreement was assessed using Cohen’s kappa coefficient; (2) latent class analysis (LCA) was employed to estimate the sensitivity (Se), specificity (Sp), and Youden index (J) of each method, with diagnostic performance further evaluated by receiver operating characteristic (ROC) curves; and (3) Bayesian sensitivity analysis was introduced to verify the robustness of the LCA model. This framework did not require a prespecified clinical gold standard but instead leveraged the combined response patterns of multiple imperfect tests to infer the latent true infection status, enabling an objective and fair comparative evaluation of diagnostic performance across methods. Results The LCA model estimated a latent prevalence of approximately 34.8% in this cohort. Ranked by overall efficacy (Youden index), the five methods were: F‑ROSE (0.8672) > RUT (0.8069) > ¹³C‑UBT (0.7889) > histopathology (0.6076) > visual inspection (0.6013). F‑ROSE exhibited the highest sensitivity (0.9472), indicating a very low missed‑diagnosis rate, while histopathology showed the highest specificity (0.9843) but relatively low sensitivity (0.6234). Bayesian analysis confirmed the high robustness of the LCA results. In addition, the turnaround time for F‑ROSE was only 25–30 minutes, significantly shorter than that for conventional histopathology (24–72 hours). Conclusion Based on the clinical data from 317 patients in this study, F‑ROSE demonstrated the best overall diagnostic performance among the five Hp detection methods, while endoscopic white‑light visual assessment exhibited relatively poor efficacy. F‑ROSE combines high sensitivity, short turnaround time, and excellent ability to identify weakly positive samples. Its area under the curve (AUC) under the soft‑label latent class (riLCA) framework was significantly superior to that of histopathology, ¹³C‑UBT, and visual inspection, and was close to that of RUT with a marginally significant difference. It also maintained reasonably high specificity and showed good agreement with conventional methods. With strong clinical feasibility and practicality, F‑ROSE holds promise as the preferred rapid testing method for clinical diagnosis of Hp infection.

  Key words: fluorescence ROSE rapid test; Helicobacter pylori; conventional histopathological examination; urea breath test; rapid urease test; endoscopic white‑light visual assessment; large‑sample clinical validation

  Submit time: 23 June 2026

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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• Zhanglin, Houyanhong, Libinghui, Wukai, Zhangjing, Yangmi. Application of Fluorescence ROSE-Based Real-Time Visualized Technology for Helicobacter pylori in the Dynamic Evaluation of the Entire Course of Eradication Therapy. 2026. doi: 10.12201/bmr.202606.00007

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  Lin Zhang, Yanhong Hou, Binghui Li, Kai Wu, Jing Zhang, Mi Yang. Real-Time Pathogen Visualization: Fluorescence ROSE versus Kyoto Classification for H. pylori Infection Activity and Eradication Assessment. 2026. doi: 10.12201/bmr.202605.00040

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• ID	Submit time	Number	Download
  1	2026-06-16	10.12201/bmr.202606.00055V1	Download

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