Study of total error specifications of lymphocyte subsets enumeration using China National EQAS data and Biological Variation Data Critical Appraisal Checklist (BIVAC)-compliant publications

2021 ◽  
Vol 59 (1) ◽  
pp. 179-186
Author(s):  
Chenbin Li ◽  
Yu Wang ◽  
Hong Lu ◽  
Zhongli Du ◽  
Chengshan Xu ◽  
...  
Keyword(s):  
Quality Control ◽  
Critical Appraisal ◽  
Total Error ◽  
Reference Intervals ◽  
Biological Variation ◽  
Lymphocyte Subset ◽  
High Concentration ◽  
Variation Data ◽  
Quality Specifications ◽  
Minimum Criteria

AbstractObjectivesIt is important to select proper quality specifications for laboratories and external quality assessment (EQA) providers for their quality control and assessment. The aim of this study is to produce new total error (TE) specifications for lymphocyte subset enumeration by analyzing the allowable TE using EQAS data and comparing them with that based on reliable biological variation (BV).MethodsA total of 54,400 results from 1,716 laboratories were collected from China National EQAS for lymphocyte subset enumeration during the period 2017–2019. The EQA data were grouped according to lower limits of reference intervals for establishing concentration-dependent specifications. The TE value that 80% of laboratories can achieve were considered as TE specifications based on state of the art. The BV studies compliant with Biological Variation Data Critical Appraisal Checklist (BIVAC) were used to calculate the three levels of TE specifications. Then these TE specifications were compared for determining the recommended TE specifications.ResultsFour parameters whose quality specifications could achieve the optimum criteria were as follows: the percentages of CD3+, CD3+CD4+ (high concentration) and CD3–CD16/56+ cells, and the absolute count of CD3–CD16/56+ cells. Only the TE specifications of CD3–CD19+ cells could achieve the minimum criteria. The TE specifications of remaining parameters should reach the desirable criteria.ConclusionsNew TE specifications were established by combining the EQA data and reliable BV data, which could help laboratories to apply proper criteria for continuous improvement of quality control, and EQA providers to use robust acceptance limits for better evaluation of EQAS results.

scholarly journals Biological Variation of Vitamins in Blood of Healthy Individuals

2005 ◽  
Vol 51 (11) ◽  
pp. 2145-2150 ◽  
Author(s):  
Dinesh K Talwar ◽  
Mohammed K Azharuddin ◽  
Cathy Williamson ◽  
Yee Ping Teoh ◽  
Donald C McMillan ◽  
...  
Keyword(s):  
Whole Blood ◽  
Total Error ◽  
Reference Intervals ◽  
Biological Variation ◽  
Reference Change Value ◽  
Objective Quality ◽  
Variation Data ◽  
Quality Specifications ◽  
Index Of Individuality ◽  
Apparently Healthy

Abstract Background: Components of biological variation can be used to define objective quality specifications (imprecision, bias, and total error), to assess the usefulness of reference values [index of individuality (II)], and to evaluate significance of changes in serial results from an individual [reference change value (RCV)]. However, biological variation data on vitamins in blood are limited. The aims of the present study were to determine the intra- and interindividual biological variation of vitamins A, E, B1, B2, B6, C, and K and carotenoids in plasma, whole blood, or erythrocytes from apparently healthy persons and to define quality specifications for vitamin measurements based on their biology. Methods: Fasting plasma, whole blood, and erythrocytes were collected from 14 healthy volunteers at regular weekly intervals over 22 weeks. Vitamins were measured by HPLC. From the data generated, the intra- (CVI) and interindividual (CVG) biological CVs were estimated for each vitamin. Derived quality specifications, II, and RCV were calculated from CVI and CVG. Results: CVI was 4.8%–38% and CVG was 10%–65% for the vitamins measured. The CVIs for vitamins A, E, B1, and B2 were lower (4.8%–7.6%) than for the other vitamins in blood. For all vitamins, CVG was higher than CVI, with II <1.0 (range, 0.36–0.95). The RCVs for vitamins were high (15.8%–108%). Apart from vitamins A, B1, and erythrocyte B2, the imprecision of our methods for measurement of vitamins in blood was within the desirable goal. Conclusions: For most vitamin measurements in plasma, whole blood, or erythrocytes, the desirable imprecision goals based on biological variation are obtainable by current methodologies. Population reference intervals for vitamins are of limited value in demonstrating deficiency or excess.

scholarly journals Critical appraisal and meta-analysis of biological variation studies on glycosylated albumin, glucose and HbA1c

2020 ◽  
Vol 1 (3) ◽  
Author(s):  
Carmen Ricós ◽  
Pilar Fernández-Calle ◽  
Elisabet Gonzalez-Lao ◽  
Margarida Simón ◽  
Jorge Díaz-Garzón ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Critical Appraisal ◽  
Meta Analysis ◽  
Biological Variation ◽  
Evidence Based ◽  
Literature Searches ◽  
Variation Data ◽  
Global Estimates ◽  
Systematic Literature Searches

AbstractObjectivesNumerous biological variation (BV) studies have been performed over the years, but the quality of these studies vary. The objectives of this study were to perform a systematic review and critical appraisal of BV studies on glycosylated albumin and to deliver updated BV estimates for glucose and HbA1c, including recently published high-quality studies such as the European Biological Variation study (EuBIVAS).MethodsSystematic literature searches were performed to identify BV studies. Nine publications not included in a previous review were identified; four for glycosylated albumin, three for glucose, and three for HbA1c. Relevant studies were appraised by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Global BV estimates were derived by meta-analysis of BIVAC-compliant studies in healthy subjects with similar study design.ResultsOne study received BIVAC grade A, 2B, and 6C. In most cases, the C-grade was associated with deficiencies in statistical analysis. BV estimates for glycosylated albumin were: CVI=1.4% (1.2–2.1) and CVG=5.7% (4.7–10.6), whereas estimates for HbA1c, CVI=1.2% (0.3–2.5), CVG=5.4% (3.3–7.3), and glucose, CVI=5.0% (4.1–12.0), CVG=8.1% (2.7–10.8) did not differ from previously published global estimates.ConclusionsThe critical appraisal and rating of BV studies according to their methodological quality, followed by a meta-analysis, generate robust, and reliable BV estimates. This study delivers updated and evidence-based BV estimates for glycosylated albumin, glucose and HbA1c.

scholarly journals Performance Criteria for Testosterone Measurements Based on Biological Variation in Adult Males: Recommendations from the Partnership for the Accurate Testing of Hormones

2012 ◽  
Vol 58 (12) ◽  
pp. 1703-1710 ◽  
Author(s):  
Yeo-Min Yun ◽  
Julianne Cook Botelho ◽  
Donald W Chandler ◽  
Alex Katayev ◽  
William L Roberts ◽  
...  
Keyword(s):  
Total Error ◽  
Full Range ◽  
Biological Variation ◽  
Analytical Performance ◽  
Performance Criteria ◽  
Performance Goals ◽  
Adult Males ◽  
Large Variability ◽  
Wide Range ◽  
Variation Data

BACKGROUND Testosterone measurements that are accurate, reliable, and comparable across methodologies are crucial to improving public health. Current US Food and Drug Administration–cleared testosterone assays have important limitations. We sought to develop assay performance requirements on the basis of biological variation that allow physiologic changes to be distinguished from assay analytical errors. METHODS From literature review, the technical advisory subcommittee of the Partnership for the Accurate Testing of Hormones compiled a database of articles regarding analytical and biological variability of testosterone. These data, mostly from direct immunoassay-based methodologies, were used to specify analytical performance goals derived from within- and between-person variability of testosterone. RESULTS The allowable limits of desirable imprecision and bias on the basis of currently available biological variation data were 5.3% and 6.4%, respectively. The total error goal was 16.7%. From recent College of American Pathologists proficiency survey data, most currently available testosterone assays missed these analytical performance goals by wide margins. Data from the recently established CDC Hormone Standardization program showed that although the overall mean bias of selected certified assays was within 6.4%, individual sample measurements could show large variability in terms of precision, bias, and total error. CONCLUSIONS Because accurate measurement of testosterone across a wide range of concentrations [approximately 2–2000 ng/dL (0.069–69.4 nmol/L)] is important, we recommend using available data on biological variation to calculate performance criteria across the full range of expected values. Additional studies should be conducted to obtain biological variation data on testosterone from women and children, and revisions should be made to the analytical goals for these patient populations.

First data on the biological variation and quality specifications for plasma ammonia concentrations in healthy subjects

2016 ◽  
Vol 54 (5) ◽  
Author(s):  
Fatma Ucar ◽  
Gonul Erden ◽  
Seyda Ozdemir ◽  
Nurgul Ozcan ◽  
Erdem Bulut ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Plasma Sample ◽  
Biological Variation ◽  
Test Results ◽  
Healthy Individuals ◽  
Variation Data ◽  
Quality Specifications ◽  
Collection Period ◽  
First Time ◽  
Analytical Variation

AbstractBackground:Most of the factors causing preanalytical and analytical variation in ammonia measurement have been identified. Biological variation data for ammonia is still lacking. We therefore estimated the components of biological variation (within-subject=CVMethods:Blood samples from 20 healthy subjects were collected in K2EDTA tubes daily over a period of 4 consecutive days from each subject. Each plasma sample was split into two aliquots; one was immediately analyzed as the samples were collected and the other was stored –80 °C until testing at the end of the collection period and analyzed at once in one analytical run. All samples were analyzed in duplicate. Estimations were calculated according to Fraser and Harris methods.Results:CVConclusions:The present study for the first time described the components of biological variation for ammonia in healthy individuals. These data regarding biological variation of ammonia could be useful for a better evaluation of ammonia test results in clinical interpretation and for determining quality specifications based on biological variation.

Supplements to a recent proposal for permissible uncertainty of measurements in laboratory medicine

2016 ◽  
Vol 40 (2) ◽  
Author(s):  
Rainer Haeckel ◽  
Werner Wosniok ◽  
Eberhard Gurr ◽  
Burkhard Peil
Keyword(s):  
Working Group ◽  
Laboratory Medicine ◽  
Reference Intervals ◽  
Standard Uncertainty ◽  
Biological Variation ◽  
Recent Proposal ◽  
New Approach ◽  
Permissible Limits ◽  
Uncertainty Of Measurements ◽  
Variation Data

Abstract:The DGKL Working Group Guide Limits (Arbeitsgruppe Richtwerte) has published a proposal for deriving permissible analytical uncertainty limits related to biological variation data. Reference intervals were used to estimate biological variation. Biological variation data as basis for permissible uncertainty limits are generally accepted. These concepts usually apply a fixed factor leading to unrealistic stringent limits for quantities with a relatively small biological variation and to very permissive limits for quantities with relatively large biological variation. The working group has suggested a non-linear relation between biological variation and permissible uncertainty limits. The new approach has been exemplified with 84 quantities listed in the RiliBÄK (official German guidelines). The algorithms published allowed to derive permissible limits for all quantitative measurands in laboratory medicine. After its publication, three supplements appear necessary: 1. additional specifications of standard uncertainty, 2. a discussion on permissible limits for diagnosis and monitoring purposes, and 3. a discussion on circular reasoning in our approach.

Within-subject and between-subject biological variation of first morning void urine amino acids in 12 healthy subjects

2020 ◽  
Vol 58 (11) ◽  
pp. 1901-1909
Author(s):  
Hamit Hakan Alp ◽  
Halil İbrahim Akbay ◽  
Erdem Çokluk ◽  
Zubeyir Huyut ◽  
Sıddık Keskin ◽  
...  
Keyword(s):  
Amino Acids ◽  
Amino Acid ◽  
Amino Acid Analysis ◽  
Healthy Subjects ◽  
Total Error ◽  
Reference Intervals ◽  
Biological Variation ◽  
Reference Change Value ◽  
Index Of Individuality ◽  
Variance Homogeneity

AbstractBackgroundUrine amino acid analysis is used for the assessment of various diseases. The aim of this study was to estimate the valid biological variation (BV) components (within- and between-subjects) required for the safe clinical application of free urine amino acids.MethodsFirst morning void urine samples were taken from 12 healthy subjects (five females, seven males) once a week for 10 consecutive weeks, and amino acid analysis was performed using an Agilent 6470 triple quadrupole tandem mass spectrometer instrument. The obtained data were subjected to normality, outlier and variance homogeneity analyses prior to coefficient of variation (CV) analysis. Within- and between-subject BV values (CVI and CVG) of 39 amino acids were determined for all subjects. In addition, the index of individuality (II), reference change value (RCV), imprecision, bias and total error were estimated using BV data obtained from our study.ResultsThe CVI values ranged from 8.9 (histidine) to 36.8% (trans-4-hydroxyprolin), while the CVG values ranged from 25.0 (1-methyl-L-histidine) to 63.3% (phenylalanine). The II value of most amino acids was less than 0.6 and ranged between 0.21 and 0.88. The imprecision, bias and total error ranged between 4.45 and 16.6, between 7.69 and 16.6, and between 18.4 and 43.2, respectively.ConclusionsThis study, designed according to a rigorous protocol, has the feature of being the first to give information about BV data of urine amino acids. We believe that the reference intervals have a limitation in the evaluation of consecutive results from an individual, so the use of RCV would be more appropriate.

scholarly journals Evaluación crítica y meta-análisis de estudios de variación biológica para albúmina glicosilada, glucosa y HbA1c

2020 ◽  
Vol 1 (3) ◽  
Author(s):  
Carmen Ricós ◽  
Pilar Fernández-Calle ◽  
Elisabet Gonzalez-Lao ◽  
Margarida Simón ◽  
Jorge Díaz-Garzón ◽  
...  
Keyword(s):  
Critical Appraisal ◽  
Biological Variation ◽  
Revisión Sistemática ◽  
Variation Data

ResumenObjetivosA lo largo de los años se han publicado numerosos artículos sobre variación biológica (VB) de diferente calidad. Los objetivos de este trabajo fueron realizar una revisión sistemática y una evaluación crítica de los estudios de VB para albúmina glicosilada y proporcionar datos actualizados de VB para glucosa y HbA1c, incluyendo prestigiosos estudios recientemente publicados como el Estudio de Variación Biológica Europea (EuBIVAS).MétodosSe hizo una búsqueda bibliográfica sistemática para identificar estudios sobre VB, encontrándose 9 estudios no incluidos en la primera revisión: 4 para albúmina glicosilada, 3 para glucosa y 3 para HbA1c. Se realizó una evaluación crítica de los estudios relevantes, utilizando la herramienta Biological Variation Data Critical Appraisal Checklist (BIVAC). Se obtuvieron los estimados globales de VB mediante meta-análisis de los estudios que cumplían los requisitos BIVAC, realizados en individuos sanos con estudios de diseño similar.ResultadosUn estudio recibió el grado A, dos el B y 6 el C. en la mayoría de los casos el grado C se asoció a deficiencias en el análisis estadístico de los datos. Los estimados de VB para albúmina glicosilada fueron: CVI = 1,4%(1,2–2,1) y CVG = 5,7%(4,7–10,6); para HbA1c, CVI = 1,2%(0,3–2,5), CVG = 5,4%(3,3–7,3) y para glucosa, CVI = 5,0%(4,1–12,0), CVG = 8,1%(2,7–10,8) no difirieron de los estimados globales previamente descritos.ConclusionesLa evaluación crítica y clasificación de los estudios de VB a tenor de su calidad metodológica, seguido de un meta-análisis, genera estimados de VB robustos y fiables. Este estudio proporciona datos de VB para albúmina glicolisada, glucosa y HbA1c actualizados y basados en la evidencia científica.

scholarly journals The Biological Variation Data Critical Appraisal Checklist: A Standard for Evaluating Studies on Biological Variation

2018 ◽  
Vol 64 (3) ◽  
pp. 501-514 ◽  
Author(s):  
Aasne K Aarsand ◽  
Thomas Røraas ◽  
Pilar Fernandez-Calle ◽  
Carmen Ricos ◽  
Jorge Díaz-Garzón ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Critical Appraisal ◽  
Clinical Chemistry ◽  
Essential Elements ◽  
Biological Variation ◽  
European Federation ◽  
Variation Data ◽  
Global Estimates ◽  
Variance Homogeneity

Abstract BACKGROUND Concern has been raised about the quality of available biological variation (BV) estimates and the effect of their application in clinical practice. A European Federation of Clinical Chemistry and Laboratory Medicine Task and Finish Group has addressed this issue. The aim of this report is to (a) describe the Biological Variation Data Critical Appraisal Checklist (BIVAC), which verifies whether publications have included all essential elements that may impact the veracity of associated BV estimates, (b) use the BIVAC to critically appraise existing BV publications on enzymes, lipids, kidney, and diabetes-related measurands, and (c) apply metaanalysis to deliver a global within-subject BV (CVI) estimate for alanine aminotransferase (ALT). METHODS In the BIVAC, publications were rated as A, B, C, or D, indicating descending compliance for 14 BIVAC quality items, focusing on study design, methodology, and statistical handling. A D grade indicated that associated BV estimates should not be applied in clinical practice. Systematic searches were applied to identify BV studies for 28 different measurands. RESULTS In total, 128 publications were identified, providing 935 different BV estimates. Nine percent achieved D scores. Outlier analysis and variance homogeneity testing were scored as C in >60% of 847 cases. Metaanalysis delivered a CVI estimate for ALT of 15.4%. CONCLUSIONS Application of BIVAC to BV publications identified deficiencies in required study detail and delivery, especially for statistical analysis. Those deficiencies impact the veracity of BV estimates. BV data from BIVAC-compliant studies can be combined to deliver robust global estimates for safe clinical application.

scholarly journals A checklist for critical appraisal of studies of biological variation

2015 ◽  
Vol 53 (6) ◽  
Author(s):  
William A. Bartlett ◽  
Federica Braga ◽  
Anna Carobene ◽  
Abdurrahman Coşkun ◽  
Richard Prusa ◽  
...  
Keyword(s):  
Critical Appraisal ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
European Federation ◽  
Data Sets ◽  
Data Set ◽  
Minimum Data ◽  
Effective Transport ◽  
Variation Data

AbstractData on biological variation are used for many purposes in laboratory medicine but concern exists over the validity of the data reported in some studies. A critical appraisal checklist has been produced by a working group established by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) to enable standardised assessment of existing and future publications of biological variation data. The checklist identifies key elements to be reported in studies to enable safe accurate and effective transport of biological variation data sets across healthcare systems. The checklist is mapped to the domains of a minimum data set required to enable this process.

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