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New Reference Ranges in Haematology for Healthy Adults Using the Modern Sysmex XE-2100 Automated Analyser.

Lisa J. Wakeman, Roger C. Munro, Chris Russell, Ann Benton, Sally Hartnell, Saad Al‐Ismail

Open publisher page 4 citations

Abstract

Abstract Establishing clearly defined, accurate reference ranges facilitates good interpretation and effective discrimination between health and disease. These can be used to obviate the need for unnecessary follow-up medical examinations thereby reducing costs. Our data represent findings from one of the most comprehensive studies ever undertaken with the XE-2100 to establish reference ranges (RRs) in healthy adults. Early morning venous samples were collected into Greiner EDTA Vacuettes (Ref: 454286) from 221 healthy laboratory personnel (F= 159;M = 62) aged 20–63 yrs for both gender. Age groups were equally represented. Samples were processed on a Sysmex XE-2100 analyser within 1 hour of collection. NCCLS guidelines (C28-A and H3-A4) were followed throughout. Outliers were excluded, data examined for normal distribution from histograms, Q-Q normality plots, skewness and kurtosis and significance levels calculated from the Kolmogorov-Smirnov and Shapiro-Wilk tests of normality. RRs for near normally distributed parameters were calculated using means ± 2SDs. RRs for non-normally distributed parameters were calculated using the log natural transformation and the antilog of the 2.5- and 97.5- percentiles. Bold parameters shown below have near-normal distribution. Non emboldened values are non-normally distributed. P values are derived from Mann-Whitney U test for differences between males and females. New Limits Historical Limits Test of M&F diff. (P value) *=sig. diff. Haemoglobin (g/dL) M 13.7–17.2 13.0–17.5 <0.05* F 12.0–15.2 11.7–15.7 RBC (x1012/L) M 4.5–5.6 4.5–5.9 <0.05* F 3.9–5.1 3.8–5.9 Hct (L/L) M 0.40–0.50 0.40–0.52 <0.05* F 0.37–0.46 0.37–0.47 MCV (fL) M 83–98 80–100 0.090 F 85–98 80–100 MCH (pg) M 28–33 27–32 0.391 F 28–33 26–31 MCHC (g/dL) M 32–36 30–36 <0.05* F 32–35 30–36 RDW (%) M 11.6–14.1 11.0–15.0 0.067 F 12.0–14.7 11.0–15.0 Reticulocytes (x109/L) M 27–93 25–85 0.138 F 22–76 25–85 Platelets ( (x109/L) M 140–320 140–450 <0.05* F 180–380 140–450 MPV (fL) M 9.4–12.2 6.3–10.1 0.426 F 9.2–12.9 6.3–10.1 Leucocytes (x109/L) 3.6–9.2 4.0–11.0 0.854 Neutrophils (x109/L) 1.7–6.2 2.0–7.5 0.760 Lymphoctes (x109/L) 1.0–3.4 1.0–4.0 0.854 Monocytes(x109/L) 0.2–0.8 0.2–0.8 0.073 Eosinophils(x109/L) 0.00–0.4 0.04–0.4 0.847 Basophils(x109/L) 0.00–0.1 0.00–0.1 0.279 Reference limits determined for total leucocytes and neutrophils are significantly lower than historical ranges. However, leucocyte counts are at their lowest in the early morning. Our findings are in general agreement with previously published data from more limited trials undertaken in other countries.

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What this paper is about

Abstract Establishing clearly defined, accurate reference ranges facilitates good interpretation and effective discrimination between health and disease. These can be used to obviate the need for unnecessary follow-up medical examinations thereby reducing costs. Our data represent findings from one of the most comprehensive studies ever undertaken with the XE-2100 to establish reference ranges (RRs) in healthy adults. Early morning venous samples were collected into Greiner EDTA Vacuettes (Ref: 454286) from 221 healthy laboratory personnel (F= 159;M = 62) aged 20–63 yrs for both gender. Age groups were equally represented. Samples were processed on a Sysmex XE-2100 analyser within 1 hour of collection. NCCLS guidelines (C28-A and H3-A4) were followed throughout. Outliers were excluded, data examined for normal distribution from histograms, Q-Q normality plots, skewness and kurtosis and significance levels calculated from the Kolmogorov-Smirnov and Shapiro-Wilk tests of normality. RRs for near normally distributed parameters were calculated using means ± 2SDs. RRs for non-normally distributed parameters were calculated using the log natural transformation and the antilog of the 2.5- and 97.5- percentiles. Bold parameters shown below have near-normal distribution. Non emboldened values are non-normally distributed. P values are derived from Mann-Whitney U test for differences between males and females. New Limits Historical Limits Test of M&F diff. (P value) *=sig. diff. Haemoglobin (g/dL) M 13.7–17.2 13.0–17.5 <0.05* F 12.0–15.2 11.7–15.7 RBC (x1012/L) M 4.5–5.6 4.5–5.9 <0.05* F 3.9–5.1 3.8–5.9 Hct (L/L) M 0.40–0.50 0.40–0.52 <0.05* F 0.37–0.46 0.37–0.47 MCV (fL) M 83–98 80–100 0.090 F 85–98 80–100 MCH (pg) M 28–33 27–32 0.391 F 28–33 26–31 MCHC (g/dL) M 32–36 30–36 <0.05* F 32–35 30–36 RDW (%) M 11.6–14.1 11.0–15.0 0.067 F 12.0–14.7 11.0–15.0 Reticulocytes (x109/L) M 27–93 25–85 0.138 F 22–76 25–85 Platelets ( (x109/L) M 140–320 140–450 <0.05* F 180–380 140–450 MPV (fL) M 9.4–12.2 6.3–10.1 0.426 F 9.2–12.9 6.3–10.1 Leucocytes (x109/L) 3.6–9.2 4.0–11.0 0.854 Neutrophils (x109/L) 1.7–6.2 2.0–7.5 0.760 Lymphoctes (x109/L) 1.0–3.4 1.0–4.0 0.854 Monocytes(x109/L) 0.2–0.8 0.2–0.8 0.073 Eosinophils(x109/L) 0.00–0.4 0.04–0.4 0.847 Basophils(x109/L) 0.00–0.1 0.00–0.1 0.279 Reference limits determined for total leucocytes and neutrophils are significantly lower than historical ranges. However, leucocyte counts are at their lowest in the early morning. Our findings are in general agreement with previously published data from more limited trials undertaken in other countries.

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Available abstract

Abstract Establishing clearly defined, accurate reference ranges facilitates good interpretation and effective discrimination between health and disease. These can be used to obviate the need for unnecessary follow-up medical examinations thereby reducing costs. Our data represent findings from one of the most comprehensive studies ever undertaken with the XE-2100 to establish reference ranges (RRs) in healthy adults. Early morning venous samples were collected into Greiner EDTA Vacuettes (Ref: 454286) from 221 healthy laboratory personnel (F= 159;M = 62) aged 20–63 yrs for both gender. Age groups were equally represented. Samples were processed on a Sysmex XE-2100 analyser within 1 hour of collection. NCCLS guidelines (C28-A and H3-A4) were followed throughout. Outliers were excluded, data examined for normal distribution from histograms, Q-Q normality plots, skewness and kurtosis and significance levels calculated from the Kolmogorov-Smirnov and Shapiro-Wilk tests of normality. RRs for near normally distributed parameters were calculated using means ± 2SDs. RRs for non-normally distributed parameters were calculated using the log natural transformation and the antilog of the 2.5- and 97.5- percentiles. Bold parameters shown below have near-normal distribution. Non emboldened values are non-normally distributed. P values are derived from Mann-Whitney U test for differences between males and females. New Limits Historical Limits Test of M&F diff. (P value) *=sig. diff. Haemoglobin (g/dL) M 13.7–17.2 13.0–17.5 <0.05* F 12.0–15.2 11.7–15.7 RBC (x1012/L) M 4.5–5.6 4.5–5.9 <0.05* F 3.9–5.1 3.8–5.9 Hct (L/L) M 0.40–0.50 0.40–0.52 <0.05* F 0.37–0.46 0.37–0.47 MCV (fL) M 83–98 80–100 0.090 F 85–98 80–100 MCH (pg) M 28–33 27–32 0.391 F 28–33 26–31 MCHC (g/dL) M 32–36 30–36 <0.05* F 32–35 30–36 RDW (%) M 11.6–14.1 11.0–15.0 0.067 F 12.0–14.7 11.0–15.0 Reticulocytes (x109/L) M 27–93 25–85 0.138 F 22–76 25–85 Platelets ( (x109/L) M 140–320 140–450 <0.05* F 180–380 140–450 MPV (fL) M 9.4–12.2 6.3–10.1 0.426 F 9.2–12.9 6.3–10.1 Leucocytes (x109/L) 3.6–9.2 4.0–11.0 0.854 Neutrophils (x109/L) 1.7–6.2 2.0–7.5 0.760 Lymphoctes (x109/L) 1.0–3.4 1.0–4.0 0.854 Monocytes(x109/L) 0.2–0.8 0.2–0.8 0.073 Eosinophils(x109/L) 0.00–0.4 0.04–0.4 0.847 Basophils(x109/L) 0.00–0.1 0.00–0.1 0.279 Reference limits determined for total leucocytes and neutrophils are significantly lower than historical ranges. However, leucocyte counts are at their lowest in the early morning. Our findings are in general agreement with previously published data from more limited trials undertaken in other countries.

Key concepts: Normality, Kurtosis, Percentile, Statistics, Normality test, Nuclear medicine, Analyser, Mathematics

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