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Establishing FBC Reference Includes Ranges in Cape Town review ferritin levels of new donors
De Koker, Co-investigators: J. Opie, A. Bird, C. Hilton, G. Bellairs B. Mitchell, R. Cable
34 th^ South frican National Blood Transfusion Congress 28-31 August 2017
Introduction: The purpose of reference rangesDefinition: Reference Values Outline and Reference Intervals
Statistical methodsThe Past: Gauteng study 2009Unpublised study 2007/2008 for establishing reference range
The Present
The Clinical and Laboratory Standards Institute (CLSI) defines obtained by observation or measurement on Introduction Reference Values as: “Values
reference individuals in the reference sample groups. interval of values bounded by the reference limit values at certain designated percentiles” The Reference Interval is usually the central.
It is of fundamental importance that the normal reference intervals for commonly performed laboratory tests reflect the ethnic and geographical diversity of the region(s) served by the laboratory, as well as age and gender Relevance - specific
differencesThe its own reference intervals or at least validate the use of valuesThe analyser used, reagent combinations and pre CLSI recommends obtained from a different setting.. that each laboratory should determine-analytical
variables the drive for also influence measurements and obtaining local laboratory reference limits. further support
Statistical Methods: Exclusion of outliers
0 Inter Quartile^ Range
Reject Reject
25th percentile 75th percentile
25th - (1.5 x IQR) 75th + (1.5 x IQR)
Horn PS et al.^ Outliers^ percentile + (1.5 IQR)^ Effect of Outliers and NonHealthy Individuals on Reference Interval Estimation= data^ less^ than^^ (Horn, 25th percentile^ Clin Chem^ 2001;47:2137)^ -^ (1.5 x IQR)^ or^ Clinical Chemistrygreater^ than 2001;47:2137^ 75th - 2145
NHLS FBC reference ranges: Largely derived from a Gauteng study Background by
Lawrie et al.^ i.e. Local reference ranges for full blood^ count and CD4 lymphocyte count testing.Only the coastal RCC, Hb and Hct^ published in SAMJ April 2009 are
different & Lewis). - derived from UK sources (Dacie
Assessment of FBC and white cell differential counts from new blood donors in the Western Cape in 2008 by Opie et al. (unpublished data) Western Cape^ -^2008
FBC results (analysed on Cell Dyn 3200) reviewed blood donors who presented during a 6 month periodAll participants questionnaireExclusions: were deemed healthy and completed a WPBTS of new
Donors ≤ 18 yrsAll post menopausal females defined as >50yrAfrican ethnicity (due to limited sample size)
1002003004005000 Original data: distribution of blood donors
Males Females Black^3365 Mixed race^198274 White^183220 % (^10203040500)
Age distribution
Percent 25.04^ <20^ 20-2943.67^ 30-3919.8^ 40-499.02^ 50-592.33^ 0.1560+ 1002003004005000 Demographics after exclusion Males Females Mixed race 169215 White (^145158)
n=
n=
Red cell count Red cell count Haemoglobin Haemoglobin Haematocrit (M)(M)(F)(M)(F) Study Reference Range^ Lower13.411.70.414.74.2 Upper16.714.90.536.25.5 Lower (NHLS)NHLS Reference Range4.53.80.4 1312 Upper (NHLS)5.54.80.5 (^1715) Haematocrit MCV MCV Platelets Platelets (^) (M)(F)(F)(M)(F) 0.3778.9 16518980 0.4793.494.6 356405 0.3679.179.1 137178 0.4698.998.9 (^373400)
Study Reference Ranges versus NHLS FBCSL:
2 a b Results show Red cell count Platelet count red cell and platelet reference ranges differ between study group and current NHLS
White cell count (M) White cell count (F) Neutrophils Neutrophils Lymphocytes (^) (M)(M)(F) Study Reference Range^ Lower3.924.731.261.4 2 Upper10.812.36.657.693.92 (NHLS)NHLS Reference Range^ Lower 44221 (NHLS)^ Upper7.57.5 (^10104) Lymphocytes Monocytes Eosinophils (^) (all)(all)(F) 1.350.270.04 (^) 0.950.674.3 (^) 0.18 (^10) 0.450.8 4
RESULTS (2008): Study Reference Ranges compared to NHLS FBCSL Reference Ranges
3 a bc Results show Male neutrophil count Monocyte count Eosinophil count white cell count differential reference ranges differ between study group and current NHLS
To establish locally derived FBC reference ranges for the Western Cape Aims for new project
To compare these locally derived reference ranges with current NHLS ranges
Secondary aims: Review Haemoglobin cut donation.Collect d deficiency among donors in the Westernata on the prevalence of iron-offs for blood
Province region.
Aims for new project
EDTA samples for FBC and DIFF are analysed on SYSMEX Counter (XN1000 Pure) within 24 hours of collection. Methods
SST specimens will be centrifuged and serum will be frozen and stored at Commercial ferritin kitARCHITECT ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitation of - 20 - Abbott AxSYM Ferritin°C
ferritin in human serum and plasma
Inclusion: First time donors eligible for donation (tested negative for HIV, HBV, HCV and syphilis). Methods
Exclusions: ^ First time donors failed Hb screening test^ (Haemocue) but fulfil all other donation criteriaDonors ≤ 18yrs and > 59yrs
Donors deferred for reasons other than low haemoglobin levelsAbnormally high or low ferritin levels
