Abdurrahman Coşkun1, Anna Carobene2, Meltem Kilercik1, Mustafa Serteser1, Sverre Sandberg3,4, Aasne K Aarsand3,4, Pilar Fernandez-Calle5,6, Niels Jonker7, William A Bartlett8, Jorge Díaz-Garzón5,6, Sibel Huet9, Cansu Kızıltaş9, Ilayda Dalgakıran9, Esra Ugur10, Ibrahim Unsal1. 1. Department of Medical Biochemistry, Acibadem Mehmet Ali Aydınlar University, School of Medicine, Atasehir, Istanbul, Turkey. 2. Servizio Medicina di Laboratorio, Ospedale San Raffaele, Milan, Italy. 3. Norwegian Quality Improvement of Primary Health Care Laboratories (Noklus), Haraldsplass Hospital, Bergen, Norway. 4. Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway. 5. Department of Laboratory Medicine, Hospital Universitario La Paz, Madrid, Spain. 6. Quality Analytical Commission of Spanish Society of Clinical Chemistry (SEQC-ML), Madrid, Spain. 7. Certe, Wilhelmina Ziekenhuis Assen, RK Assen, theNetherlands. 8. Blood Sciences, Ninewells Hospital and Medical School, Scotland, UK. 9. Acibadem Mehmet Ali Aydınlar University, School of Medicine, Atasehir, Istanbul, Turkey. 10. Acibadem Mehmet Ali Aydınlar University, School of Health Science, Atasehir, Istanbul, Turkey.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.