Evaluation and comparison of Abbott Jaffe and enzymatic creatinine methods: Could the old method meet the new requirements?

摘要

Background The aim of this study is to evaluate and compare the analytical performance characteristics of the two creatinine methods based on the Jaffe and enzymatic methods. Methods Two original creatinine methods, Jaffe and enzymatic, were evaluated on Architect c16000 automated analyzer via limit of detection ( LOD ) and limit of quantitation ( LOQ ), linearity, intra‐assay and inter‐assay precision, and comparability in serum and urine samples. The method comparison and bias estimation using patient samples according to CLSI guideline were performed on 230 serum and 141 urine samples by analyzing on the same auto‐analyzer. Results The LOD s were determined as 0.1?mg/dL for both serum methods and as 0.25 and 0.07?mg/dL for the Jaffe and the enzymatic urine method respectively. The LOQ s were similar with 0.05?mg/dL value for both serum methods, and enzymatic urine method had a lower LOQ than Jaffe urine method, values at 0.5 and 2?mg/dL respectively. Both methods were linear up to 65?mg/dL for serum and 260?mg/dL for urine. The intra‐assay and inter‐assay precision data were under desirable levels in both methods. The higher correlations were determined between two methods in serum and urine ( r =.9994, r =.9998 respectively). On the other hand, Jaffe method gave the higher creatinine results than enzymatic method, especially at the low concentrations in both serum and urine. Conclusions Both Jaffe and enzymatic methods were found to meet the analytical performance requirements in routine use. However, enzymatic method was found to have better performance in low creatinine levels.