혈청 및 소변 단백질 모세관 전기영동 Capillarys 3 TERA 성능평가
Performance Evaluation of Capillarys 3 TERA for Serum and Urine Protein Capillary Electrophoresis
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Background: Monoclonal protein (M-protein), crucial for diagnosing and monitoring multiple myeloma, is detected and quantified using serum and urine protein electrophoresis (SPEP/UPEP). Agarose gel electrophoresis (AGE), traditionally used, is increasingly being replaced by capillary electrophoresis (CE). This study compares CE-based Capillarys 3 TERA (Sebia) with AGE-based Epalyzer (Helena Laboratories). Methods: We assessed Capillarys 3 TERA for precision, linearity, and carryover rates following CLSI guidelines. Precision was assessed across six fractions (albumin, alpha-1, alpha-2, beta-1, beta-2, and gamma-globulin) using control materials, measured five times daily over five days. Lin- earity was tested for M-protein concentrations (0.4–5.2 g/dL) using patients samples. We compared 58 serum and 60 urine samples between Ep- alyzer and Capillarys 3 TERA. UPEP results from spot urine and 24-hour toluene-preserved samples from 20 patients were compared. Results: Precision showed coefficients of variation below 5% for all fractions. M-protein demonstrated strong linearity, and no carryover. Corre- lation coefficients between Epalyzer and Capillarys 3 TERA for serum/urine were: albumin 0.9648/0.9876; alpha-1, 0.8943/0.8622; alpha-2, 0.9619/0.5252; beta, 0.7907/0.7792; gamma, 0.3176/0.9549; and M-protein, 0.9913/0.9564. M-protein detection concordance was 94.8% (se- rum) and 91.7% (urine). Sensitivity/specificity for M protein detection in serum was 96.9%/92.3 for Capillarys 3 TERA and 93.8%/100.0% for Epalyzer. In urine, Capillarys 3 TERA showed 90.5%/100.0%, while Epalyzer showed 76.2%/100.0%. M-protein levels were higher in random spot urine than in 24-hour samples. Conclusions: Capillarys 3 TERA demonstrated good analytical performance with high sensitivity and specificity for M-protein detection, though quantification differences between methods should be considered.
Abstract
Background: Monoclonal protein (M-protein), crucial for diagnosing and monitoring multiple myeloma, is detected and quantified using serum and urine protein electrophoresis (SPEP/UPEP). Agarose gel electrophoresis (AGE), traditionally used, is increasingly being replaced by capillary electrophoresis (CE). This study compares CE-based Capillarys 3 TERA (Sebia) with AGE-based Epalyzer (Helena Laboratories). Methods: We assessed Capillarys 3 TERA for precision, linearity, and carryover rates following CLSI guidelines. Precision was assessed across six fractions (albumin, alpha-1, alpha-2, beta-1, beta-2, and gamma-globulin) using control materials, measured five times daily over five days. Lin- earity was tested for M-protein concentrations (0.4–5.2 g/dL) using patients samples. We compared 58 serum and 60 urine samples between Ep- alyzer and Capillarys 3 TERA. UPEP results from spot urine and 24-hour toluene-preserved samples from 20 patients were compared. Results: Precision showed coefficients of variation below 5% for all fractions. M-protein demonstrated strong linearity, and no carryover. Corre- lation coefficients between Epalyzer and Capillarys 3 TERA for serum/urine were: albumin 0.9648/0.9876; alpha-1, 0.8943/0.8622; alpha-2, 0.9619/0.5252; beta, 0.7907/0.7792; gamma, 0.3176/0.9549; and M-protein, 0.9913/0.9564. M-protein detection concordance was 94.8% (se- rum) and 91.7% (urine). Sensitivity/specificity for M protein detection in serum was 96.9%/92.3 for Capillarys 3 TERA and 93.8%/100.0% for Epalyzer. In urine, Capillarys 3 TERA showed 90.5%/100.0%, while Epalyzer showed 76.2%/100.0%. M-protein levels were higher in random spot urine than in 24-hour samples. Conclusions: Capillarys 3 TERA demonstrated good analytical performance with high sensitivity and specificity for M-protein detection, though quantification differences between methods should be considered.