The EuBIVAS Project: Within- and Between-Subject Biological Variation Data for Serum Creatinine Using Enzymatic and Alkaline Picrate Methods and Implications for Monitoring

被引：64

作者：

Carobene, Anna ^{[1
,12
]}

Marino, Irene ^{[1
]}

Coskun, Abdurrahman ^{[2
,12
]}

Serteser, Mustafa ^{[2
]}

Unsal, Ibrahim ^{[2
]}

Guerra, Elena ^{[1
]}

Bartlett, William A. ^{[3
,12
]}

Sandberg, Sverre ^{[4
,5
,12
]}

Aarsand, Aasne Karine ^{[4
,12
]}

Sylte, Marit Sverresdotter ^{[4
]}

Roraas, Thomas ^{[5
,12
]}

Solvik, Una Orvim ^{[6
]}

Fernandez-Calle, Pilar ^{[7
,8
,12
]}

Diaz-Garzon, Jorge ^{[7
,8
]}

Tosato, Francesca ^{[9
]}

Plebani, Mario ^{[9
]}

Jonker, Niels ^{[10
,12
]}

Barla, Gerhard ^{[10
]}

Ceriotti, Ferruccio ^{[11
]}

机构：

[1] Osped San Raffaele, Serv Med Lab, Milan, Italy

[2] Acibadem Univ, Sch Med, Istanbul, Turkey

[3] Ninewells Hosp & Med Sch, Blood Sci, Dundee, Scotland

[4] Haukeland Hosp, Lab Clin Biochem, Bergen, Norway

[5] Haraldsplass Deaconess Hosp, Norwegian Qual Improvement Lab Examinat Noklus, Bergen, Norway

[6] Univ Bergen, Dept Global Publ Hlth & Primary Care, Bergen, Norway

[7] Hosp Univ La Paz, Madrid, Spain

[8] Spanish Soc Clin Chem SEQC, Qual Analyt Commiss, Madrid, Spain

[9] Univ Hosp, Dept Lab Med, Padua, Italy

[10] Wilhelmina Ziekenhuis Assen, Certe, Europaweg Zuid 1, NL-9401 RK Assen, Netherlands

[11] Osped Maggiore Policlin, Cen Lab, Fdn IRCCS Ca Granda, Milan, Italy

[12] European Federat Clin Chem & Lab Med, Biol Variat Working Grp, Milan, Italy

来源：

CLINICAL CHEMISTRY | 2017年 / 63卷 / 09期

关键词：

EUROPEAN FEDERATION; CLINICAL-CHEMISTRY; WORKING GROUP; SPECIFICATIONS; QUALITY; STANDARDIZATION; HEALTHY; ASSAYS;

D O I：

10.1373/clinchem.2017.275115

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

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 degrees 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, 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. (C) 2017 American Association for Clinical Chemistry

引用

页码：1527 / 1536

页数：10

共 28 条

[1]

[Anonymous], RIMEL IJLAM S

[2]

[Anonymous], 1983, Statistical Methods

[3]

[Anonymous], The 2014 update

[4] A checklist for critical appraisal of studies of biological variation [J].

Bartlett, William A. ;

Braga, Federica ;

Carobene, Anna ;

Coskun, Abdurrahman ;

Prusa, Richard ;

Fernandez-Calle, Pilar ;

Roraas, Thomas ;

Jonker, Neils ;

Sandberg, Sverre .

CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2015, 53 (06) :879-885

[5] Enzymatic but not compensated Jaffe methods reach the desirable specifications of NKDEP at normal levels of creatinine. Results of the French multicentric evaluation [J].

Boutten, Anne ;

Bargnoux, Anne-Sophie ;

Carlier, Marie-Christine ;

Delanaye, Pierre ;

Rozet, Eric ;

Delatour, Vincent ;

Cavalier, Etienne ;

Hanser, Anne-Marie ;

Froissart, Marc ;

Cristol, Jean-Paul ;

Pieroni, Laurence .

CLINICA CHIMICA ACTA, 2013, 419 :132-135

[6] Biological Variation Estimates Obtained from 91 Healthy Study Participants for 9 Enzymes in Serum [J].

Carobene, Anna ;

Roraas, Thomas ;

Solvik, Una Orvim ;

Sylte, Marit Sverresdotter ;

Sandberg, Sverre ;

Guerra, Elena ;

Marino, Irene ;

Jonker, Niels ;

Barla, Gerhard ;

Bartlett, William A. ;

Fernandez-Calle, Pilar ;

Diaz-Garzon, Jorge ;

Tosato, Francesca ;

Plebani, Mario ;

Coskun, Abdurrahman ;

Serteser, Mustafa ;

Unsal, Ibrahim ;

Ceriottil, Ferruccio .

CLINICAL CHEMISTRY, 2017, 63 (06) :1141-1150

[7] Sample collections from healthy volunteers for biological variation estimates' update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine [J].

Carobene, Anna ;

Strollo, Marta ;

Jonker, Niels ;

Barla, Gerhard ;

Bartlett, William A. ;

Sandberg, Sverre ;

Sylte, Marit Sverresdotter ;

Roraas, Thomas ;

Solvik, Una Orvim ;

Fernandez-Calle, Pilar ;

Diaz-Garzon, Jorge ;

Tosato, Francesca ;

Plebani, Mario ;

Coskun, Abdurrahman ;

Serteser, Mustafa ;

Unsal, Ibrahim ;

Ceriotti, Ferruccio .

CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2016, 54 (10) :1599-1608

[8] Reliability of biological variation data available in an online database: need for improvement [J].

Carobene, Anna .

CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2015, 53 (06) :871-877

[9] Evaluation of the impact of standardization process on the quality of serum creatinine determination in Italian laboratories [J].

Carobene, Anna ;

Ceriotti, Ferruccio ;

Infusino, Ilenia ;

Frusciante, Erika ;

Panteghini, Mauro .

CLINICA CHIMICA ACTA, 2014, 427 :100-106

[10] Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference [J].

Ceriotti, Ferruccio ;

Fernandez-Calle, Pilar ;

Klee, George G. ;

Nordin, Gunnar ;

Sandberg, Sverre ;

Streichert, Thomas ;

Vives-Corrons, Joan-Lluis ;

Panteghini, Mauro .

CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2017, 55 (02) :189-194

← 1 2 3 →