The EuBIVAS project: within- and between-subject biological variation data for serum creatinine using enzymatic and alkaline picrate methods and implications for monitoring

Anna Carobene (Lead / Corresponding author), Irene Marino, Abdurrahman Coskun, Mustafa Serteser, Ibrahim Unsal, Elena Guerra, William A. Bartlett, Sverre Sandberg, Aasne Karine Aarsand, Marit Sverresdotter Sylte, Thomas Roraas, Una Orvim Solvik, Pilar Fernandez-Calle, Jorge Diaz-Garzón, Francesca Tosato, Mario Plebani, Niels Jonker, Gerhard Barla, Ferruccio Ceriotti

Research output: Contribution to journalArticlepeer-review

38 Citations (Scopus)

Abstract

BACKGROUND: The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) European Biological Variation Study (EuBIVAS) has been established to deliver rigorously determined biological variation (BV) indices. EuBIVAS determined BV for serum creatinine using the enzymatic and alkaline picrate measurement methods. METHOD: In total, 91 healthy individuals (38 males, 53 females; age range, 21-69 years) were bled for 10 consecutive weeks at 6 European laboratories. An equivalent protocol was followed at each center. Sera were stored at =80 °C before analysis. Analyses for each patient were performed in duplicate within a single run on an ADVIA 2400 system (San Raffaele Hospital, Milan). The data were subjected to outlier and homogeneity analysis before performing CV-ANOVA to determine BV and analytical variation (CVA) estimates with confidence intervals (CI). RESULTS: The within-subjectBVestimates [CVI (95% CI)] were similar for enzymatic [4.4% (4.2- 4.7)] and alkaline picrate [4.7% (4.4-4.9)] methods and lower than the estimate presently available online (CVI 5.9%). No significant male/female BV differences were found. Significant differences were observed in mean creatinine values between men and women and between Turkish individuals and those of other nationalities. Between-subject BV (CVG) estimates, stratified accordingly, producedCVG values similar to historical BV data. CVA was 1.1% for the enzymatic and 4.4% for alkaline picrate methods, indicating that alkaline picrate methods fail to fulfill analytical performance specifications for imprecision (CVAPS). CONCLUSIONS: The serum creatinine CVI obtained by EuBIVAS specifies a more stringent CVAPS than previously identified. The alkaline picrate method failed to meet this CVAPS, raising questions regarding its future use.

Original languageEnglish
Pages (from-to)1527-1536
Number of pages10
JournalClinical Chemistry
Volume63
Issue number9
Early online date28 Aug 2017
DOIs
Publication statusPublished - 1 Sep 2017

Fingerprint

Dive into the research topics of 'The EuBIVAS project: within- and between-subject biological variation data for serum creatinine using enzymatic and alkaline picrate methods and implications for monitoring'. Together they form a unique fingerprint.

Cite this