Short- and medium-term biological variation estimates of leukocytes extended to differential count and morphology-structural parameters (cell population data) in blood samples obtained from healthy people

• Published in: Clinica chimica acta Vol. 473; pp. 147 - 156
• Main Authors: Buoro, Sabrina, Carobene, Anna, Seghezzi, Michela, Manenti, Barbara, Pacioni, Aurelio, Ceriotti, Ferruccio, Ottomano, Cosimo, Lippi, Giuseppe
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.10.2017
• Subjects: Adult; Biological variation; Cell population data; Differential count; Female; Healthy Volunteers; Hematology analyzer; Humans; Immature granulocytes; Leukocyte Count - standards; Leukocytes; Leukocytes - cytology; Male; Reference change value; Reference Values; Time Factors; APS; CBC; Reference change value; MO-X; MO-Y; MO-Z; Leukocytes; CIs; MO-WY; LY; MO-WX; TEASP; MO-WZ; SDA; NE-WZ; Biological variation; BV; FSC; SFL; SDI; BAPS; NE-WX; IG; Immature granulocytes; MO; SSC; Cell population data; RCVs; CVAPS; EO; Hematology analyzer; CVA; NE-SSC; Differential count; CVG; CPD; XN; CVI; NE; LY-WX; LY-Z; LY-WY; LY-Y; LY-WZ; LY-X; NE-FSC; BA; NE-SFL
• ISSN: 0009-8981; 1873-3492; 1873-3492
• DOI: 10.1016/j.cca.2017.07.009

Recent studies showed that some cell population data (CPD) parameters of neutrophils may be useful for diagnosing myelodysplastic syndromes and sepsis, for the differential diagnosis of acute promyelocytic leukemia, and some CPD parameters of lymphocytes may be a valuable tool for preliminary screening of B cell lymphoproliferative disease. Notwithstanding the knowledge, no information has been made available about their analytical quality specification. This study was aimed to define short- and medium-term biological variation (BV) estimates and reference change value (RCV) of leukocyte count, extended leukocyte differential and CPD. The study population consisted of 43 healthy volunteers, who participated in the assessment of medium-term (21 volunteers; blood sampling once a week for 5 consecutive weeks) and short-term (22 volunteers; blood sampling once a day for 5 consecutive days) BV, using Sysmex XN. Outlier analysis was carried out before CV-ANOVA, to determine BV estimates and their confidence intervals. The medium-term and short-term within-subject BV (CVI) was comprised between 0.6–19.7% and 0.2–21.9%, whereas the medium-term and short-term between-subjects BV (CVG) was comprised between 1.2–61.5% and 1.1–58.5%. The RCVs were found to be similar for all the parameters, in both arms of the study, except for some CPD parameters. This study allowed accurately estimating the BV of many leukocyte parameters, some of which have not been currently explored. The kinetics of some leukocyte turnover suggests the use of short-term BV data for calculating analytical goals and RCV. •Biological variation estimates of extended leucocyte differential counts and cell population data•The reference change value of extended leucocyte differential counts and cell population data•Analytical performance specifications for extended leucocyte differential counts and cell population data.