Anna Carobene1,2, Irene Marino3, Abdurrahman Coşkun4,2, Mustafa Serteser4, Ibrahim Unsal4, Elena Guerra3, William A Bartlett5,2, Sverre Sandberg6,7,2, Aasne Karine Aarsand6,2, Marit Sverresdotter Sylte6, Thomas Røraas7,2, Una Ørvim Sølvik8, Pilar Fernandez-Calle9,2, Jorge Díaz-Garzón9, Francesca Tosato10, Mario Plebani10, Niels Jonker11,2, Gerhard Barla11, Ferruccio Ceriotti12. 1. Servizio di Medicina di Laboratorio, Ospedale San Raffaele, Milan, Italy; carobene.anna@hsr.it. 2. Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, http://efcclm.eu/science/wg-biological-variation, www.biologicalvariation.com. 3. Servizio di Medicina di Laboratorio, Ospedale San Raffaele, Milan, Italy. 4. Acibadem University School of Medicine, Atasehir, Istanbul, Turkey. 5. Blood Sciences, Ninewells Hospital & Medical School, Scotland, UK. 6. Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway. 7. Norwegian Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway. 8. Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway. 9. Hospital Universitario La Paz, Madrid, Spain, and Quality Analytical Commission of Spanish Society of Clinical Chemistry (SEQC). 10. Department of Laboratory Medicine University Hospital, Padua, Italy. 11. Certe, Wilhelmina Ziekenhuis Assen, Europaweg-Zuid 1, 9401 RK Assen, the Netherlands. 12. Central Laboratory, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
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-subject BV estimates [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, produced CVG 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.
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-subject BV estimates [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, produced CVG 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.
Authors: Michela Bottani; Giuseppe Banfi; Elena Guerra; Massimo Locatelli; Aasne K Aarsand; Abdurrahman Coşkun; Jorge Díaz-Garzón; Pilar Fernandez-Calle; Sverre Sandberg; Ferruccio Ceriotti; Elisabet González-Lao; Margarita Simon; Anna Carobene Journal: Ann Transl Med Date: 2020-07
Authors: Hiroyuki Takita; Daniel Scotcher; Rajkumar Chinnadurai; Philip A Kalra; Aleksandra Galetin Journal: CPT Pharmacometrics Syst Pharmacol Date: 2020-11-23