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

Abstract

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 LODs 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 LOQs 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.

Late onset neonatal acute kidney injury: results from the AWAKEN Study

“…The Jaffe methodology for assessment of creatinine can be affected by bilirubin or other pigmented influences. The different analysis methods and automated analysers produce higher levels of creatinine with the Jaffe method, but this is predominantly at low levels of creatinine (25, 26). If the definition of AKI was based on a serum creatinine cut off, the association between late AKI and the Jaffe reaction would be more clear.…”

Creatinine‐Based Renal Function Assessment in Pediatric Drug Development: An Analysis Using Clinical Data for Renally Eliminated Drugs

“…13 In our study, most of the subjects with supraphysiological eGFR 14 were associated with eGFR/CL ratio > 1.5, accompanied by a measurement of serum creatinine level (< 0.2 mg/dL) close to the limit of detection for the assay (0.1 mg/dL; Figure 2a). 15 The patients with supraphysiological eGFR did not show proportionally high values in the clearance of these drugs. The discrepancy between eGFR and CL is more evident for patients with low SCR (Figure 2a).…”

Application of multisegment injection on quantification of creatinine and standard addition analysis of urinary 5‐hydroxyindoleacetic acid simultaneously with creatinine normalization

“…Although the Jaffé reaction and enzymatic assays are often used to determine creatinine levels in routine analysis, the interferences in these methods caused by endogenous and exogenous compounds are hard to eliminate due to a lack of adequate separation processes . To overcome these limitations, analytical methods based on various techniques, including LC–MS , GC–MS , CE–UV , ambient ionization MS , have been developed to quantify urinary creatinine.…”