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KMID : 1100720230430060565
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Annals of Laboratory Medicine
2023 Volume.43 No. 6 p.565 ~ p.573
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Effect of Two Cystatin C Reagents and Four Equations on Glomerular Filtration Rate Estimations After Standardization
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Lee Hyun-Seung
Bae Go-Eun
Lee Jung-Eun
Park Hyung-Doo
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Abstract
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Background: Serum cystatin C (cysC), which is less affected by sex, race, and muscle mass than creatinine, is a useful biomarker of the estimated glomerular filtration rate (eGFR). The standardization of cysC measurements remains controversial, although a certified reference material (ERM-DA471/IFCC) is available. Moreover, the effect of combinations of cysC reagents and equations for eGFR is unclear.
Methods: We conducted a simulation analysis of cysC measured using two reagents standardized against ERM-DA471/IFCC?Gentian cystatin C immunoassay (Gentiancys; GentianAS, Moss, Norway) and Roche Tina-quant Cystatin C Gen.2 (Rochecys; Roche, Mannheim, Germany)?on a Cobas c702 system (Roche) and eGFR generated by eight combinations of four equations: 2012 cystatin C-based Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPIcys); the Caucasian, Asian, pediatric, and adult equation (CAPAeq); full age spectrum equation (FASeq); and 2023 cystatin C-based European Kidney Function Consortium equation (EKFCcys).
Results: A total of 148 participants (mean age, 60.5±14.5 years; 43% female) were enrolled. The mean cysC was 1.72±1.44 mg/L for Gentiancys and 1.71±1.35 mg/L for Rochecys. Regression analysis showed concordance between the reagents within 0.85?4.40 mg/L when using ±7.61% total allowable error. Lin’s concordance correlation coefficient of eGFR, by combining the measuring system and equation, varied from 0.73 to 1.00.
Conclusions: The equivalence of cysC values at low concentrations (<0.85 mg/L) between the two reagents was unsatisfactory. Results obtained with different measurement systems could lead to larger differences in eGFR varying with the combination.
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KEYWORD
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Cystatin C, Estimated glomerular filtration rate, Chronic Kidney Disease Epidemiology Collaboration, Caucasian, Asian, European Kidney Function Consortium
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