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

Carobene, Anna; Strollo, Marta; Jonker, Niels; Barla, Gerhard; Bartlett, William A.; Sandberg, Sverre; Sylte, Marit Sverresdotter; Røraas, Thomas; Sølvik, Una Ørvim; Fernández–Calle, Pilar; Díaz-Garzón, Jorge; Tosato, Francesca; Plebani, Mario; Coşkun, Abdurrahman; Serteser, Mustafa; Ünsal, İbrahim; Ceriotti, Ferruccio

doi:10.1515/cclm-2016-0035

Cited by 82 publications

(68 citation statements)

References 20 publications

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“…BV is highly beneficial for improving the laboratory quality management level. In 2014, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) questioned the online BV data on the Westgard website about its effectiveness and reliability . The EFLM BV working group then proposed the biological variation data critical appraisal checklist (BIVAC).…”

Section: Introductionmentioning

confidence: 94%

“…questioned the online BV data on the Westgard website about its effectiveness and reliability. 5,6 The EFLM BV working group then proposed the biological variation data critical appraisal checklist (BIVAC). This checklist is used to standardize operations for assessing existing biological variation studies and guiding future biological variation studies.…”

Section: Federation Of Clinical Chemistry and Laboratory Medicine (Eflm)mentioning

confidence: 99%

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Evaluation of biological variation of glycated hemoglobin and glycated albumin in healthy Chinese subjects

Liu

Zeng

et al. 2018

Clinical Laboratory Analysis

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Background Glycated hemoglobin (HbA1c) and glycated serum albumin ( GSA ) are used to evaluate the mean blood glucose levels. To ensure safe clinical application of HbA1c and GSA , reliable biological variation ( BV ) data are required. The aim of this research was to define the BV of HbA1c and GSA employing stringent rules. Methods Blood samples were drawn from 19 healthy subjects (10 females, nine males) once per week for 5 weeks. All samples were analyzed using enzymatic method for GSA and HPLC for HbA1c. The data were assessed for outliers, normality and variance homogeneity, and coefficient of variation (by ANOVA ) for BV . Sex‐stratified BV including within‐subject ( CV I ) and between‐subject ( CV G ) was defined for HbA1c and GSA . Results The following estimates for BV values for CV I and CV G , respectively, were GSA : 1.23% and 4.67%, Alb: 0.75% and 3.18%, and HbA1c: 0.12% and 2.91%. The RCV of GSA was 3.61%, and HbA1c was 1.41%. And the II was 0.26 for GSA , and 0.07 for HbA1c, both of them less than 0.6. According to the 95% CI , the CV I of HbA1c was statistically different between females and males. And both the CV G of HbA1c and GSA were statistically different between females and males. Conclusion All CV I and CV G estimates were lower than those reported in the online BV database. And there is a significant difference between males and females. Analytical performance specifications derived from BV of this research can be applied internationally.

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Section: Introductionmentioning

confidence: 94%

Section: Federation Of Clinical Chemistry and Laboratory Medicine (Eflm)mentioning

confidence: 99%

Evaluation of biological variation of glycated hemoglobin and glycated albumin in healthy Chinese subjects

Liu

Zeng

et al. 2018

Clinical Laboratory Analysis

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“…To this aim, the EFLM Working Group on Biological Variation (WG-BV) is working to a European project using a biobank of samples from 91 healthy subjects to be used to produce high quality data [49]. The WG-BV has recently published biological variability data for nine enzymes and creatinine in serum [50,51].…”

Section: Stimulating Studies Using Milan Models To Obtain Psmentioning

confidence: 99%

Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

Panteghini

Ceriotti

Jones

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:Measurements in clinical laboratories produce results needed in the diagnosis and monitoring of patients. These results are always characterized by some uncertainty. What quality is needed and what measurement errors can be tolerated without jeopardizing patient safety should therefore be defined and specified for each analyte having clinical use. When these specifications are defined, the total examination process will be "fit for purpose" and the laboratory professionals should then set up rules to control the measuring systems to ensure they perform within specifications. The laboratory community has used different models to set performance specifications (PS). Recently, it was felt that there was a need to revisit different models and, at the same time, to emphasize the presuppositions for using the different models. Therefore, in 2014 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) organized a Strategic Conference in Milan. It was felt that there was a need for more detailed discussions on, for instance, PS for EQAS, which measurands should use which models to set PS and how to set PS for the extra-analytical phases. There was also a need to critically evaluate the quality of data on biological variation studies and further discussing the use of the total error (TE) concept. Consequently, EFLM established five Task Finish Groups (TFGs) to address each of these topics. The TFGs are finishing their activity on 2017 and the content of this paper includes deliverables from these groups.

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“…Coagulation test results can be affected by various preanalytical factors such as the type of biological sample, participants' age, disease, medications etc. For this reason, to assure derivation of highest quality BV estimates, stringent preanalytical and analytical protocols were followed similar to the EFLM control list 12 and a rigorous statistical approach was applied.…”

Section: Discussionmentioning

confidence: 99%

“…CVI and CVG data were used for calculating the number of samples required to estimate performance specifications desired for imprecision (CVAPS) and bias (BiasAPS), individuality index (II), reference change value (RCV) and homeostatic set points (NHSP). The following equations were used for this purpose: CVA refers to the analytical variation, 12 and D refers to the allowable percent deviation from the true homeostatic set point; Z is 1.96 (for P value <0.05).…”

Section: Analytical Performance Specifications and Other Applicationsmentioning

confidence: 99%

Biological variation estimates of prothrombin time, activated partial thromboplastin time, and fibrinogen in 28 healthy individuals

Falay

Şeneş

Korkmaz

et al. 2018

Int J Lab Hematology

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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

Abstract: Background: Biological variation (BV) data have many fundamental applications in laboratory medicine. At the 1st

Cited by 82 publications

References 20 publications

Evaluation of biological variation of glycated hemoglobin and glycated albumin in healthy Chinese subjects

Evaluation of biological variation of glycated hemoglobin and glycated albumin in healthy Chinese subjects

Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

Biological variation estimates of prothrombin time, activated partial thromboplastin time, and fibrinogen in 28 healthy individuals

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