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Background <p>Increasing evidence indicates that blood-based biomarkers, particularly phosphorylated tau (pTau) 217 and the pTau217/amyloid‑β (Aβ) 42 ratio, demonstrate strong diagnostic performance for Alzheimer’s disease (AD) and may offer a minimally invasive alternative to cerebrospinal fluid (CSF) assays and Aβ PET imaging. There is an urgent need to develop local plasma pTau217 and pTau217/Aβ42 ratio assay and to establish population-appropriate diagnostic cutoffs tailored to Chinese populations.</p> Methods <p>This study included 831 individuals from a community-based memory screening cohort and 301 patients from a hospital-based cohort with confirmed Aβ pathology. Plasma pTau217, pTau181, and their ratios to Aβ42 were measured using a high-sensitivity direct chemiluminescence (DCL) immunoassay incorporating proprietary China-developed antibodies. Data-driven Gaussian mixture modeling (GMM) was applied to the community cohort to derive biomarker cutoffs; the diagnostic performance of these cutoffs was validated in the patients with confirmed Aβ pathology. A two-cutoff approach was established in the hospital-based cohort. Multivariate regression analysis was performed to assessed potential confounding effects from routine blood biochemical parameters.</p> Results <p>GMM identified cutoffs of 4.380 pg/mL for pTau217 and 0.670 for the pTau217/Aβ42 ratio. These values closely matched cutoffs derived from the maximum Youden index (4.296 pg/mL for pTau217 and 0.706 for pTau217/Aβ42) and achieved high diagnostic accuracy (up to 89%) for Aβ pathology in the hospital-based cohort with confirmed Aβ pathology, outperforming pTau181-based measures. Only the pTau217/Aβ42 ratio was unaffected by routine plasma biochemistry. Using a two-cutoff workflow, pTau217 or the pTau217/Aβ42 ratio definitively classified approximately 90% of patients as positive or negative, leaving an intermediate-risk zone of &lt; 10%.</p> Conclusions <p>The China-developed DCL immunoassay reliably measures plasma pTau217 and the pTau217/Aβ42 ratio with high diagnostic accuracy for detecting Aβ pathology. The biochemical stability of the pTau217/Aβ42 ratio supports its potential as a practical, less invasive alternative to CSF or PET testing in Chinese populations.</p>

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Performance of plasma pTau217, pTau181 and their ratios to Aβ42 in detecting Aβ pathology using a China-developed direct chemiluminescence assay

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月29日

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  • Dan Yang,
  • Zhihong Ke,
  • Nihong Chen,
  • Ling Yue,
  • Shuai Chen,
  • Maoyuan Jiang,
  • Zheqi Hu,
  • Chunming Xie,
  • Wenhao Zhu,
  • Jingxian Xu,
  • Linjie Yu,
  • Limoran Tang,
  • Hui Zhao,
  • Jingde Dong,
  • Chaosheng Li,
  • Guofang Chen,
  • Benyan Luo,
  • Jiewen Zhang,
  • Yun Xu

摘要

Background

Increasing evidence indicates that blood-based biomarkers, particularly phosphorylated tau (pTau) 217 and the pTau217/amyloid‑β (Aβ) 42 ratio, demonstrate strong diagnostic performance for Alzheimer’s disease (AD) and may offer a minimally invasive alternative to cerebrospinal fluid (CSF) assays and Aβ PET imaging. There is an urgent need to develop local plasma pTau217 and pTau217/Aβ42 ratio assay and to establish population-appropriate diagnostic cutoffs tailored to Chinese populations.

Methods

This study included 831 individuals from a community-based memory screening cohort and 301 patients from a hospital-based cohort with confirmed Aβ pathology. Plasma pTau217, pTau181, and their ratios to Aβ42 were measured using a high-sensitivity direct chemiluminescence (DCL) immunoassay incorporating proprietary China-developed antibodies. Data-driven Gaussian mixture modeling (GMM) was applied to the community cohort to derive biomarker cutoffs; the diagnostic performance of these cutoffs was validated in the patients with confirmed Aβ pathology. A two-cutoff approach was established in the hospital-based cohort. Multivariate regression analysis was performed to assessed potential confounding effects from routine blood biochemical parameters.

Results

GMM identified cutoffs of 4.380 pg/mL for pTau217 and 0.670 for the pTau217/Aβ42 ratio. These values closely matched cutoffs derived from the maximum Youden index (4.296 pg/mL for pTau217 and 0.706 for pTau217/Aβ42) and achieved high diagnostic accuracy (up to 89%) for Aβ pathology in the hospital-based cohort with confirmed Aβ pathology, outperforming pTau181-based measures. Only the pTau217/Aβ42 ratio was unaffected by routine plasma biochemistry. Using a two-cutoff workflow, pTau217 or the pTau217/Aβ42 ratio definitively classified approximately 90% of patients as positive or negative, leaving an intermediate-risk zone of < 10%.

Conclusions

The China-developed DCL immunoassay reliably measures plasma pTau217 and the pTau217/Aβ42 ratio with high diagnostic accuracy for detecting Aβ pathology. The biochemical stability of the pTau217/Aβ42 ratio supports its potential as a practical, less invasive alternative to CSF or PET testing in Chinese populations.