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The study was designed to evaluate the performance of five automated immunoturbidimetric assays to quantify urinary albumin, each corresponding to a combination of a reagent and an analyzer (Olympus on AU640, Roche on Cobas Integra, Abbott on Architect, Ortho-Clinical Diagnostics Vitros on Fusion and Siemens on Dimension).To assess imprecision, albumin was measured in three urinary pools with a mean value of 25, 66 and 131 mg/L. One hundred and eight patient urine samples were then used to compare each turbidimetric method using the Passing-Bablok regression and Bland-Altman analyses. Concordance of the albumin/creatinine ratio (ACR), according to the albuminuria classifications proposed by the KDIGO, was calculated to test the agreement between the different assays.All immunoturbidimetric methods evaluated in this study exhibited acceptable imprecision (CV6%). Mean values for 108 urine samples varied from 0.5 to 762.2 mg/L. Significant differences were found (p0.05) between all methods except between Olympus and Ortho (p=1.0) and between Abbott and Roche (p=0.12). Regarding the albuminuria categories based on the ACR proposed by the KDIGO, only the classification obtained with the Roche method was significantly different from the four other methods (p0.001).We demonstrated that all assays were not strictly equivalent which could affect ACR categories in clinical practice, suggesting the need for harmonization of commercial methods.

Objectives Analytical and clinical performances of the new standardized cystatin C particle-enhanced turbidimetric immunoassay (PETIA) using DiaSys reagents on Olympus AU2700® analyzer were evaluated. Design and methods We have studied imprecision, linearity, limit of detection and limit of quantification of this new immunoassay. Method comparison was assessed in relation to results generated by the standardized Siemens-particle-enhanced nephelometric immunoassay (PENIA). In order to evaluate the clinical relevance of this assay, estimated glomerular filtration rate (GFR) was calculated using MDRD, CKD-EPI creatinine, CKD-EPI cystatin C 2012 and CKD-EPI creatinine–cystatin C 2012 equations and compared to GFR measured using urinary clearance of 99mTc-DTPA in 100 hypertensive patients. Results Cystatin C measurements using DiaSys reagents have reliable analytical performances and are comparable to the standardized Siemens-PENIA method (bias of 0.01 mg/L). The mean measured GFR was 90.0 ± 29.7 mL/min/1.73 m2. Bias and accuracy of the three CKD-EPI equations were better than the MDRD. Both CKD-EPI creatinine-based and cystatin C-based formulae had similar bias, precision and accuracy. The combined creatinine–cystatin C equation was significantly more accurate and precise than the CKD-EPI creatinine equation in patients with GFR above 60 mL/min/1.73 m2. Conclusions The use of cystatin C in a combined equation with creatinine could improve the accuracy of eGFR in the reference interval.