Polymeric Immunoglobulin Receptor-Lateral Flow Immunochromatographic Strip for Cholangiocarcinoma Screening.

INTRODUCTION

Effective screening or diagnostic tests for cholangiocarcinoma (CCA) are currently unavailable. Most patients are either asymptomatic or exhibit only mild symptoms in the early stages, which results in delayed medical attention and diagnosis at advanced stages. This highlights the urgent need for a reliable screening method for CCA.

METHODS

This study developed and evaluated a rapid lateral flow immunochromatographic strip (LFICS) for the screening of patients with CCA using plasma samples. The LFICS was designed to target plasma polymeric immunoglobulin receptor (PIGR), a potential biomarker for CCA. For the study, 69 healthy subjects (HS), 80 subjects infected with Opisthorchis viverrini (OV), 95 patients with CCA, and 84 subjects with other cancers were recruited. A 100 µL plasma sample from each subject was applied directly to the PIGR-LFICS, and the results were interpreted 15 min after sample loading.

RESULTS

An area under the curve (AUC) of 0.7999 was obtained for the ROC curve comparing HS and OV vs. CCA, with 74.74% sensitivity, 85.23% specificity, 76.34% positive predictive value (PPV), 84.11% negative predictive value (NPV), and 81.15% accuracy. Cross-reactivity testing of the PIGR-LFICS with other cancers yielded a sensitivity of 74.74%, a specificity of 81.55%, a PPV of 62.28%, a NPV of 88.79%, and an overall accuracy of 79.57%.

CONCLUSION

The PIGR-LFICS test demonstrated a satisfactory performance in all measures, suggesting its potential utility for point-of-care testing and screening patients with CCA in community settings.