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<p>The Sebia Capillary 3 Octa System is a next-generation capillary electrophoresis platform engineered for an accurate quantification of Hb A₂ and Hb F in the diagnosis of thalassemia and haemoglobinopathies. Rigorous analytical verification is required prior to routine implementation. This study aimed to perform a comprehensive method verification of the Sebia Capillary 3 Octa System in accordance with international laboratory standards (ISO 15189). Forty-seven EDTA-anticoagulated whole blood samples with normal and abnormal hemoglobin profiles were analyzed. Verification included within- and between-run precision, linearity, and carry-over assessment. Method comparison against Bio-Rad Variant II and Sebia Capillary 2 Flex Piercing was performed. Agreement for Hb A₂ and Hb F was evaluated using linear regression and Bland–Altman analysis. Imprecision for Hb A₂ and Hb F was within acceptable limits. Linearity was demonstrated across both low and high concentration ranges, encompassing clinically relevant thresholds. Method comparison showed strong correlation and good agreement between the Sebia Capillary 3 Octa and the reference analyzers for both Hb A₂ and Hb F. No clinically significant carry-over was observed. The Sebia Capillary 3 Octa System demonstrated robust analytical performance and excellent agreement with established platforms. Its operational efficiency and high-throughput capability support its implementation as a primary screening method in clinical laboratories, offering a reliable alternative to conventional techniques.</p>

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Clinical Laboratory Verification of the Sebia Capillary 3 Octa System for Thalassemia Screening Programs

  • 期刊论文

  • 发表日期：

    2026年6月29日

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  • Rosnah Bahar,
  • Razan Hayati Zulkeflee,
  • Wan Nor Fazila Hafizan Wan Nik,
  • Suryati Abdullah,
  • Muhammad Faiz Mohd Ismail,
  • Hani Ajrina Zulkeflee,
  • Ahmad Zakwan Mustafa,
  • Zefarina Zulkafli,
  • Shafini Mohamed Yusoff

摘要

The Sebia Capillary 3 Octa System is a next-generation capillary electrophoresis platform engineered for an accurate quantification of Hb A₂ and Hb F in the diagnosis of thalassemia and haemoglobinopathies. Rigorous analytical verification is required prior to routine implementation. This study aimed to perform a comprehensive method verification of the Sebia Capillary 3 Octa System in accordance with international laboratory standards (ISO 15189). Forty-seven EDTA-anticoagulated whole blood samples with normal and abnormal hemoglobin profiles were analyzed. Verification included within- and between-run precision, linearity, and carry-over assessment. Method comparison against Bio-Rad Variant II and Sebia Capillary 2 Flex Piercing was performed. Agreement for Hb A₂ and Hb F was evaluated using linear regression and Bland–Altman analysis. Imprecision for Hb A₂ and Hb F was within acceptable limits. Linearity was demonstrated across both low and high concentration ranges, encompassing clinically relevant thresholds. Method comparison showed strong correlation and good agreement between the Sebia Capillary 3 Octa and the reference analyzers for both Hb A₂ and Hb F. No clinically significant carry-over was observed. The Sebia Capillary 3 Octa System demonstrated robust analytical performance and excellent agreement with established platforms. Its operational efficiency and high-throughput capability support its implementation as a primary screening method in clinical laboratories, offering a reliable alternative to conventional techniques.