title: 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.
authors.affiliation: Medical Biochemistry Department, Dokuz Eylül University Medical Faculty, Izmir, Turkey.|Central Laboratory, Dokuz Eylül University Hospital, Izmir, Turkey.
authors.forename: Tuncay
authors.identifier: http://orcid.org/0000-0003-3440-3513
authors.initials: T
authors.lastname: Küme
authors.affiliation: Biochemistry Laboratory, Biga State Hospital, Çanakkale, Turkey.
authors.forename: Barıs
authors.initials: B
authors.lastname: Sağlam
authors.affiliation: Central Laboratory, Dokuz Eylül University Hospital, Izmir, Turkey.|Medical Microbiology Department, Dokuz Eylül University Medical Faculty, Izmir, Turkey.
authors.forename: Cem
authors.initials: C
authors.lastname: Ergon
authors.affiliation: Medical Biochemistry Department, Dokuz Eylül University Medical Faculty, Izmir, Turkey.|Central Laboratory, Dokuz Eylül University Hospital, Izmir, Turkey.
authors.forename: Ali Rıza
authors.initials: AR
authors.lastname: Sisman
mesh_terms: D001774:Blood Chemical Analysis / Q000379:methods* / Q000592:standards*; D003404:Creatinine / Q000097:blood* / Q000652:urine*; D006801:Humans; D057230:Limit of Detection; D016014:Linear Models; D015203:Reproducibility of Results
chemical_list: D003404:Creatinine
keywords: Jaffe; creatinine; enzymatic; method comparison; method validation