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<p>China’s blood station guidelines permit chemiluminescent immunoassays for transfusion-related infections, but none are approved for Treponema pallidum antibody screening. This study evaluates the Wantai Chemiluminescent Microparticle Immunoassay (CMIA) using the Wan200 + analyzer. 5,301 donor samples were tested with Wantai CMIA and two ELISA methods. Discordant results were confirmed by the TPPA test. Diagnostic performance was assessed with a reference serum panel of 611 samples. Wantai CMIA showed 100% sensitivity and 99.96% specificity. Both ELISA methods showed 100% sensitivity and specificity. In reference serum tests, all reagents demonstrated 100% sensitivity, with specificity of 81.25% for Wantai CMIA and GBI ELISA, and 86.72% for Wantai ELISA. The Wantai CMIA demonstrated superior sensitivity and specificity, aligning with current blood center ELISA reagents, and meets blood donor screening standards, making it a reliable tool for syphilis antibody detection.</p>

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Clinical performance evaluation of the Wantai chemiluminescent microparticle immunoassay for Treponema pallidum antibody screening in blood donors

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月28日

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  • Jianfeng Chen,
  • Qi Zuo,
  • Ran Ju,
  • Ping Chen

摘要

China’s blood station guidelines permit chemiluminescent immunoassays for transfusion-related infections, but none are approved for Treponema pallidum antibody screening. This study evaluates the Wantai Chemiluminescent Microparticle Immunoassay (CMIA) using the Wan200 + analyzer. 5,301 donor samples were tested with Wantai CMIA and two ELISA methods. Discordant results were confirmed by the TPPA test. Diagnostic performance was assessed with a reference serum panel of 611 samples. Wantai CMIA showed 100% sensitivity and 99.96% specificity. Both ELISA methods showed 100% sensitivity and specificity. In reference serum tests, all reagents demonstrated 100% sensitivity, with specificity of 81.25% for Wantai CMIA and GBI ELISA, and 86.72% for Wantai ELISA. The Wantai CMIA demonstrated superior sensitivity and specificity, aligning with current blood center ELISA reagents, and meets blood donor screening standards, making it a reliable tool for syphilis antibody detection.