Within-subject and between-subject biological variation estimates of 21 hematological parameters in 30 healthy subjects

The complete blood count (CBC) is used to evaluate health status in the contexts of various clinical situations such as anemia, infection, inflammation, trauma, malignancies, etc. To ensure safe clinical application of the CBC, reliable biological variation (BV) data are required. The study aim was...

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Vydáno v:Clinical chemistry and laboratory medicine Ročník 56; číslo 8; s. 1309
Hlavní autoři: Coşkun, Abdurrahman, Carobene, Anna, Kilercik, Meltem, Serteser, Mustafa, Sandberg, Sverre, Aarsand, Aasne K, Fernandez-Calle, Pilar, Jonker, Niels, Bartlett, William A, Díaz-Garzón, Jorge, Huet, Sibel, Kızıltaş, Cansu, Dalgakıran, Ilayda, Ugur, Esra, Unsal, Ibrahim
Médium: Journal Article
Jazyk:angličtina
Vydáno: Germany 26.07.2018
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ISSN:1437-4331, 1437-4331
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Abstract The complete blood count (CBC) is used to evaluate health status in the contexts of various clinical situations such as anemia, infection, inflammation, trauma, malignancies, etc. To ensure safe clinical application of the CBC, reliable biological variation (BV) data are required. The study aim was to define the BVs of CBC parameters employing a strict protocol. Blood samples, drawn from 30 healthy subjects (17 females, 13 males) once weekly for 10 weeks, were analyzed using a Sysmex XN 3000 instrument. The data were assessed for normality, trends, outliers and variance homogeneity prior to coefficient of variation (CV)-analysis of variance (ANOVA). Sex-stratified within-subject (CVI) and between-subjects (CVG) BV estimates were determined for 21 CBC parameters. For leukocyte parameters, with the exception of lymphocytes and basophils, significant differences were found between female/male CVI estimates. The mean values of all erythrocyte-, reticulocyte- and platelet parameters differed significantly between the sexes, except for mean corpuscular hemoglobin concentration, mean corpuscular volume and platelet numbers. Most CVI and CVG estimates appear to be lower than those previously published. Our study, based on a rigorous protocol, provides updated and more stringent BV estimates for CBC parameters. Sex stratification of data is necessary when exploring the significance of changes in consecutive results and when setting analytical performance specifications.
AbstractList The complete blood count (CBC) is used to evaluate health status in the contexts of various clinical situations such as anemia, infection, inflammation, trauma, malignancies, etc. To ensure safe clinical application of the CBC, reliable biological variation (BV) data are required. The study aim was to define the BVs of CBC parameters employing a strict protocol. Blood samples, drawn from 30 healthy subjects (17 females, 13 males) once weekly for 10 weeks, were analyzed using a Sysmex XN 3000 instrument. The data were assessed for normality, trends, outliers and variance homogeneity prior to coefficient of variation (CV)-analysis of variance (ANOVA). Sex-stratified within-subject (CVI) and between-subjects (CVG) BV estimates were determined for 21 CBC parameters. For leukocyte parameters, with the exception of lymphocytes and basophils, significant differences were found between female/male CVI estimates. The mean values of all erythrocyte-, reticulocyte- and platelet parameters differed significantly between the sexes, except for mean corpuscular hemoglobin concentration, mean corpuscular volume and platelet numbers. Most CVI and CVG estimates appear to be lower than those previously published. Our study, based on a rigorous protocol, provides updated and more stringent BV estimates for CBC parameters. Sex stratification of data is necessary when exploring the significance of changes in consecutive results and when setting analytical performance specifications.
The complete blood count (CBC) is used to evaluate health status in the contexts of various clinical situations such as anemia, infection, inflammation, trauma, malignancies, etc. To ensure safe clinical application of the CBC, reliable biological variation (BV) data are required. The study aim was to define the BVs of CBC parameters employing a strict protocol.BACKGROUNDThe complete blood count (CBC) is used to evaluate health status in the contexts of various clinical situations such as anemia, infection, inflammation, trauma, malignancies, etc. To ensure safe clinical application of the CBC, reliable biological variation (BV) data are required. The study aim was to define the BVs of CBC parameters employing a strict protocol.Blood samples, drawn from 30 healthy subjects (17 females, 13 males) once weekly for 10 weeks, were analyzed using a Sysmex XN 3000 instrument. The data were assessed for normality, trends, outliers and variance homogeneity prior to coefficient of variation (CV)-analysis of variance (ANOVA). Sex-stratified within-subject (CVI) and between-subjects (CVG) BV estimates were determined for 21 CBC parameters.METHODSBlood samples, drawn from 30 healthy subjects (17 females, 13 males) once weekly for 10 weeks, were analyzed using a Sysmex XN 3000 instrument. The data were assessed for normality, trends, outliers and variance homogeneity prior to coefficient of variation (CV)-analysis of variance (ANOVA). Sex-stratified within-subject (CVI) and between-subjects (CVG) BV estimates were determined for 21 CBC parameters.For leukocyte parameters, with the exception of lymphocytes and basophils, significant differences were found between female/male CVI estimates. The mean values of all erythrocyte-, reticulocyte- and platelet parameters differed significantly between the sexes, except for mean corpuscular hemoglobin concentration, mean corpuscular volume and platelet numbers. Most CVI and CVG estimates appear to be lower than those previously published.RESULTSFor leukocyte parameters, with the exception of lymphocytes and basophils, significant differences were found between female/male CVI estimates. The mean values of all erythrocyte-, reticulocyte- and platelet parameters differed significantly between the sexes, except for mean corpuscular hemoglobin concentration, mean corpuscular volume and platelet numbers. Most CVI and CVG estimates appear to be lower than those previously published.Our study, based on a rigorous protocol, provides updated and more stringent BV estimates for CBC parameters. Sex stratification of data is necessary when exploring the significance of changes in consecutive results and when setting analytical performance specifications.CONCLUSIONSOur study, based on a rigorous protocol, provides updated and more stringent BV estimates for CBC parameters. Sex stratification of data is necessary when exploring the significance of changes in consecutive results and when setting analytical performance specifications.
Author Kilercik, Meltem
Jonker, Niels
Carobene, Anna
Bartlett, William A
Unsal, Ibrahim
Serteser, Mustafa
Kızıltaş, Cansu
Díaz-Garzón, Jorge
Coşkun, Abdurrahman
Ugur, Esra
Aarsand, Aasne K
Huet, Sibel
Sandberg, Sverre
Fernandez-Calle, Pilar
Dalgakıran, Ilayda
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  givenname: Abdurrahman
  surname: Coşkun
  fullname: Coşkun, Abdurrahman
  organization: Department of Medical Biochemistry, Acibadem Mehmet Ali Aydınlar University, School of Medicine, Atasehir, Istanbul, Turkey
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  givenname: Anna
  surname: Carobene
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  givenname: Meltem
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  givenname: Mustafa
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  fullname: Aarsand, Aasne K
  organization: Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway
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  surname: Fernandez-Calle
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  organization: Quality Analytical Commission of Spanish Society of Clinical Chemistry (SEQC-ML), Madrid, Spain
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  givenname: Niels
  surname: Jonker
  fullname: Jonker, Niels
  organization: Certe, Wilhelmina Ziekenhuis Assen, RK Assen, theNetherlands
– sequence: 9
  givenname: William A
  surname: Bartlett
  fullname: Bartlett, William A
  organization: Blood Sciences, Ninewells Hospital and Medical School, Scotland, UK
– sequence: 10
  givenname: Jorge
  surname: Díaz-Garzón
  fullname: Díaz-Garzón, Jorge
  organization: Quality Analytical Commission of Spanish Society of Clinical Chemistry (SEQC-ML), Madrid, Spain
– sequence: 11
  givenname: Sibel
  surname: Huet
  fullname: Huet, Sibel
  organization: Acibadem Mehmet Ali Aydınlar University, School of Medicine, Atasehir, Istanbul, Turkey
– sequence: 12
  givenname: Cansu
  surname: Kızıltaş
  fullname: Kızıltaş, Cansu
  organization: Acibadem Mehmet Ali Aydınlar University, School of Medicine, Atasehir, Istanbul, Turkey
– sequence: 13
  givenname: Ilayda
  surname: Dalgakıran
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  organization: Acibadem Mehmet Ali Aydınlar University, School of Medicine, Atasehir, Istanbul, Turkey
– sequence: 14
  givenname: Esra
  surname: Ugur
  fullname: Ugur, Esra
  organization: Acibadem Mehmet Ali Aydınlar University, School of Health Science, Atasehir, Istanbul, Turkey
– sequence: 15
  givenname: Ibrahim
  surname: Unsal
  fullname: Unsal, Ibrahim
  organization: Department of Medical Biochemistry, Acibadem Mehmet Ali Aydınlar University, School of Medicine, Atasehir, Istanbul, Turkey
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Title Within-subject and between-subject biological variation estimates of 21 hematological parameters in 30 healthy subjects
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