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Introduction: This paper is a report of an ICSH review of policies and practices for internal quality control (IQC) policy for haematology cell counters among regulatory bodies, cell counter manufacturers and diagnostic laboratories. It includes a discussion of the study findings and links to separate ICSH guidance for such policies and practices. The application of internal quality control (IQC) methods is an essential pre‐requisite for all clinical laboratory testing including the blood count (Full Blood Count, FBC, or Complete Blood Count, CBC). Methods: The ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers (Abbott Diagnostics, Beckman Coulter, Horiba Medical Diagnostic Instruments & Systems, Mindray Medical International, Siemens Healthcare Diagnostics and Sysmex Corporation) and a survey issued to 191 diagnostic laboratories in four countries (China, Republic of Ireland, Spain and the United Kingdom) on their IQC practice and approach to use of commercial IQC materials. Results: This has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial controls. The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values and action limits used with control materials, and frequency of running commercial controls materials. Conclusions: These findings and their implications for IQC Practice are discussed in this paper. They are used to inform a separate guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories. [ABSTRACT FROM AUTHOR]

This paper is a description of the ICSH guidance for internal quality control (IQC) policy for blood cell counters. It follows from and links to a separate ICSH review for such policies and practices. The ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers and a survey issued to 191 diagnostic laboratories in four countries (China, the Republic of Ireland, Spain, and the United Kingdom) on their IQC practice and approach to the use of commercial IQC materials. This has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial control materials. The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values, and action limits used with commercial control materials, and frequency of running commercial controls materials. These findings and their implications for IQC Practice are addressed in this guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories. [ABSTRACT FROM AUTHOR]

Introduction: UniCel DxH900 (Beckman Coulter, Miami, Florida, USA) is a quantitative, multi‐parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories. The aim of this study was to evaluate the analytical performance of the new DxH900 analyzer to verify its diagnostic and clinical utility in the hematology laboratory of a tertiary care hospital in Spain. The most important and novel feature offered by DxH900 analyzer is providing MDW (monocyte distribution width), a new hematologic parameter which is being clinically validated as an early sepsis indicator with promising results. Methods: We evaluated imprecision (including MDW), linearity, and carryover of DxH900. Method comparison for cell blood count (CBC) was performed in relation to DxH800 with 100 samples. We compared leukocyte differential (DIFF) from DxH900 with manual 400‐cell differential. 390 samples were assessed for flag performance. Results: Results obtained for between days and within‐run imprecision were good. DxH900 showed excellent linearity (R = 1.00) over analytical range for white blood cells, red blood cells, hemoglobin, platelets, and reticulocyte count (RET) (R = 0.96) and no significant carryover effect. CBC and RET on the DxH900 correlated well with DxH800 (R ≥ 0.99). Comparison with manual differential showed excellent correlation (R ≥ 0.88), except for basophils. Flagging performance exhibited sensitivity over 90% for majority of alarm messages and very high negative predictive value (over 95%). Conclusion: UniCel DxH900 Coulter analyzer provides reliable results and fully comparable to DxH800. DxH900 is an accurate, highly precise analyzer with good analytical performances to be used effectively in high‐volume laboratories. [ABSTRACT FROM AUTHOR]

Objectives: To provide reference values for haematological indices in Spanish adolescents according to age and gender. Methods: A cross sectional study conducted in five Spanish cities was performed. Blood was drawn from a representative sample of 581 adolescents with age ranging from 13 to 17–18.5 yr. Age- and gender-specific means, standard deviations and percentiles were determined for the following parameters: total red blood cell counts (RBC), haemoglobin concentration (Hb), haematocrit percentage (Hct), mean corpuscular volume (MCV), mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, red cell distribution width and total white blood cell (WBC) counts as well as counts and percentage of neutrophils, lymphocytes, monocytes, eosinophils and basophils; platelet count (PLT), mean platelet volume and plateletcrit percentage. Results: Younger male subjects presented lower RBC, Hb, Hct and MCV means that their older counterpart. By contrast these differences were not observed in female subjects. As expected, RBC, Hb and Hct mean values in males were found significantly higher than in girls for all studied age groups. No significant differences were observed in WBC by age and gender. PLT values gradually decreased with age, except for females aged 17–18.5 yr. Conclusion: The present study provides reference data on the distribution of haematological indices of Spanish adolescents. These data can be useful biomarkers of the nutritional status in adolescents. [ABSTRACT FROM AUTHOR]

Blood samples were taken from 75 free-ranging southern chamois (Rupicapra pyrenaica) captured in drive-nets in Catalonia, north-eastern Spain, and 20 haematological and 24 serum biochemical variables were analysed. The values were similar to those of other species of the Caprinae subfamily, except for cortisol, the concentration of which was higher. The red blood cell count (RBC), platelets and leucocytes, and the concentrations of cortisol, lactate, muscular enzymes and γ-globulins were higher in summer than in spring, whereas the mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, and the concentrations of cholesterol, total bilirubin and creatinine were lower. Adult males had higher RBCs and haemoglobin values than females in summer, and lower leucocyte, lymphocyte and neutrophil counts than females and yearling males. The concentrations of triglycerides, total bilirubin, lactate, creatinine, urea, chloride and α2-globulins were higher in adult males than yearling males. In summer the adult females had higher values for platelets, lymphocytes, cortisol, sodium and muscular enzymes. [ABSTRACT FROM AUTHOR]