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<p>Hepatitis B Virus (HBV) infection remains a major global health concern, particularly in low-resource settings where access to conventional diagnostic platforms is limited. To address this challenge, we developed and optimized a colorimetric Loop-Mediated Isothermal Amplification (LAMP) assay for the rapid and visual detection of HBV. The assay operates at a constant temperature of 65&#xa0;°C for 50&#xa0;min and utilizes cresol red as a pH indicator dye, producing a distinct pink-to-yellow color change in positive samples. Analytical validation demonstrated a limit of detection (LoD) of 10 ng/µL, and no cross-reactivity was observed with Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) confirming assay specificity. Clinical evaluation of 200 qPCR-confirmed HBV-positive plasma samples and 20 qPCR-confirmed negative donor plasmas, the colorimetric LAMP assay achieved a sensitivity of 62.0% (124/200; 95% CI 54.9–68.8) and a specificity of 100.0% (20/20; 95% CI 83.2–100.0). Notably, sensitivity exceeded 90% for samples with viral loads ≥ 10,000 IU/mL (log₁₀ ≥4.0) when evaluated against the Cobas HBV real-time PCR assay. This LAMP-based platform offers a rapid, cost-effective, and user-friendly diagnostic tool, particularly suitable for point-of-care use in resource-limited settings. Its deployment could significantly enhance early HBV detection, inform timely clinical management, and contribute to broader efforts in HBV control and prevention.<!--Query ID="Q1" Text="We noticed that two set of Figures &#x0026; Tables captions are provided, so kindly check and confirm the processed Figures and Tables captions are correctly identified."--></p>

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Colorimetric loop-mediated isothermal amplification for the rapid and visual detection of hepatitis B virus

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月11日

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  • Saadullah Jan Khan,
  • Likhitphorn Khamai,
  • Nang Kham-Kjing,
  • Woottichai Khamduang,
  • Sayamon Hongjaisee

摘要

Hepatitis B Virus (HBV) infection remains a major global health concern, particularly in low-resource settings where access to conventional diagnostic platforms is limited. To address this challenge, we developed and optimized a colorimetric Loop-Mediated Isothermal Amplification (LAMP) assay for the rapid and visual detection of HBV. The assay operates at a constant temperature of 65 °C for 50 min and utilizes cresol red as a pH indicator dye, producing a distinct pink-to-yellow color change in positive samples. Analytical validation demonstrated a limit of detection (LoD) of 10 ng/µL, and no cross-reactivity was observed with Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) confirming assay specificity. Clinical evaluation of 200 qPCR-confirmed HBV-positive plasma samples and 20 qPCR-confirmed negative donor plasmas, the colorimetric LAMP assay achieved a sensitivity of 62.0% (124/200; 95% CI 54.9–68.8) and a specificity of 100.0% (20/20; 95% CI 83.2–100.0). Notably, sensitivity exceeded 90% for samples with viral loads ≥ 10,000 IU/mL (log₁₀ ≥4.0) when evaluated against the Cobas HBV real-time PCR assay. This LAMP-based platform offers a rapid, cost-effective, and user-friendly diagnostic tool, particularly suitable for point-of-care use in resource-limited settings. Its deployment could significantly enhance early HBV detection, inform timely clinical management, and contribute to broader efforts in HBV control and prevention.