Dataset Information

Reference intervals for selected haematological and biochemical parameters among apparently healthy adults in different eco-geographical zones in Ghana.

ABSTRACT:

Background

Due to the influence of gender, race/genetics, age, lifestyle habits and geography on the references intervals (RIs), the Clinical and Laboratory Standards Institute (CLSI) recommends the determination of population-specific RIs. Ghana continues to depend on pre-established RIs from other countries which poses the risk of misdiagnoses and wrong treatment. This study presents the haemato-biochemical RIs from four eco-geographical zones in Ghana.

Methods

In this population-based cross-sectional study, a total of 1227 randomly selected healthy voluntary blood donors from the four eco-geographic zones (Coastal Savannah, Rain Forest, Savannah and Transitional) were enrolled and screened. Based on the CLSI Guidance Document C28A2992, the data of eligible participants were used to non-parametrically determine the RIs for the haemato-biochemical parameters at the 2.5th and 97.5th percentiles. Comparison of analytes by gender was done by Wilcoxon rank sum test and eco-geographic differences were assessed using the Kruskal-Wallis with the Dunn post hoc multiple comparison tests.

Results

There were statistically significant differences in most of the haematological parameters (RBC, Hb, HCT, MCV, PLT, WBC; p-values <0.0001 and MCH; p-value = 0.007), and biochemical analytes (Urea, Cr, Trig, HDL-C, AST, ALT, ALP, GGT, BID, BIT, Prot-T and Albumin; p-values <0.0001) based on gender. Significant inter eco-geographic (intra-population) variations and substantial differences between the established RI and the RIs accompanying the analyzers used were also observed.

Conclusion

This study reports significant inter-sex and inter-geographical differences in haemato-biochemical RIs in Ghana as well as differences in RIs with both the RIs accompanying the analyzers and those of other countries. Determining RIs representative of populations and including them in the report systems of laboratories to ensure effective and efficient healthcare service delivery is thus recommended.

SUBMITTER: Abbam G

PROVIDER: S-EPMC7817015 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Reference intervals for selected haematological and biochemical parameters among apparently healthy adults in different eco-geographical zones in Ghana.

Abbam Gabriel G Abbam Gabriel G Tandoh Samuel S Tetteh Mary M Afrifah David Amoah DA Annani-Akollor Max Efui ME Owiredu Eddie-Williams EW Gyasi Charles C Adu-Gyamfi Constance C Sackey Benedict B Debrah Alexander Yaw AY Addai-Mensah Otchere O

PloS one 20210120 1

<h4>Background</h4>Due to the influence of gender, race/genetics, age, lifestyle habits and geography on the references intervals (RIs), the Clinical and Laboratory Standards Institute (CLSI) recommends the determination of population-specific RIs. Ghana continues to depend on pre-established RIs from other countries which poses the risk of misdiagnoses and wrong treatment. This study presents the haemato-biochemical RIs from four eco-geographical zones in Ghana.<h4>Methods</h4>In this populatio ...[more]

PMID: 33471853

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Project description:BACKGROUND:Clinical laboratory reference intervals (RIs) are essential for clinical diagnosis, treatment and therapeutic monitoring. Locally established RIs are required to correctly interpret clinical laboratory results. In Ethiopia, clinical laboratory test results are interpreted based on RIs derived from a western population. METHODS:A multicenter cross-sectional study was conducted among blood donors in Amhara National Regional State, Ethiopia from March 2016 to May 2017. A total of 1,175 apparently healthy study participants were included in the study from four blood banks in the region. All clinical chemistry parameters were analyzed using Mindray BS-200E full automated clinical chemistry analyzer. The 95% RIs were estimated using reference limits at 2.5th percentile for the lower reference limit and 97.5th percentile for the upper reference limit. Kolmogorov-Sminorv and Wilcoxon rank-sum tests were used to check data distribution normality and whether partitions were needed between variables, respectively. RESULTS:RIs established include: ALT 5.13-42.88 U/L for males and 4.3-37 U/L for females; AST 12.13-46.88 for males and 10-43.8 U/L for females; ALP 77.2-475.8 U/L for males and 89-381 U/L for females; amylase 29-309.8 U/L for males and 29-287.9 U/L for females; GGT 7-69.8 U/L for males and 6-39.1 U/L for females; total bilirubin 0.11-1.18 mg/dl for males and 0.08-0.91 mg/dl for females; creatinine 0.48-1.13 mg/dl for males and 0.47-1.09 mg/dl for females; total cholesterol 78.13-211.75 mg/dl for males and 83.6-202.7 mg/dl for females; total protein 5.7-9.7 g/dl for males and 5.6-9.47 for females; triglycerides 36-221.9 mg/dl for males and 35.3-201.5 mg/dl for females; urea 12-43 mg/dl for males and 10-38.7 mg/dl for females; and uric acid 2.7-6.9 mg/dl for males and 2.1-5.9 mg/dl for females. CONCLUSION:This study has established RIs for routine clinical chemistry parameters. These RIs are important as they support the interpretation of clinical laboratory results for medical decision making and other health-related activities.

Project description:BACKGROUND:Locally established clinical laboratory reference intervals (RIs) are required to interpret laboratory test results for screening, diagnosis and prognosis. The objective of this study was establishing reference interval of clinical chemistry parameters among apparently healthy adolescents aged between 12 and 17 years in Mekelle, Tigrai, northern part of Ethiopia. METHODS:Community based cross sectional study was employed from December 2018 to March 2019 in Mekelle city among 172 males and 172 females based on Multi stage sampling technique. Blood samples were tested for Fasting blood sugar (FBS), alanine aminino transferase (ALT), aspartate amino transferase (AST), alkaline phosphatase (ALP), Creatinine, urea, total protein, albumin (ALB), direct and indirect bilirubin (BIL.D and BIL.T) using 25 Bio system clinical chemistry analyzer. Results were analyzed using SPSS version 23 software and based on the Clinical Laboratory Standard Institute (CLSI)/ International Federation of Clinical Chemistry (IFCC) C 28-A3 Guideline which defines the reference interval as the 95% central range of 2.5th and 97.5th percentiles. Mann Whitney U test, descriptive statistics and box and whisker were statistical tools used for analysis. RESULTS:This study observed statistically significant differences between males and females in ALP, ALT, AST, Urea and Creatinine Reference intervals. The established reference intervals for males and females, respectively, were: ALP (U/L) 79.48-492.12 versus 63.56-253.34, ALT (U/L) 4.54-23.69 versus 5.1-20.03, AST 15.7-39.1 versus 13.3-28.5, Urea (mg/dL) 9.33-24.99 versus 7.43-23.11, and Creatinine (mg/dL) 0.393-0.957 versus 0.301-0.846. The combined RIs for Total Protein (g/dL) was 6.08-7.85, ALB (g/dL) 4.42-5.46, FBS(mg/dL) 65-110, BIL.D (mg/dL) 0.033-0.532, and BIL.T (mg/dL) 0.106-0.812. CONCLUSIONS:The result showed marked difference among sex and with the company derived values for selected clinical chemistry parameters. Thus, use of age and sex specific locally established reference intervals for clinical chemistry parameters is recommended.

Project description:Establishing national population haematological and immunological reference ranges are essential for clinical management of patients. However, there is scarcity of information on community based haematological reference ranges established from Ethiopian population. Therefore, this study aimed at determining haematological and CD4+ T cells reference ranges in healthy adults from East and West Gojjam zones, Ethiopia.Community based cross-sectional study was conducted from May 2015 to December 2015 in healthy adult residents of Gojjam zone. A total of 481(246 females and 235 males) healthy adults enrolled in the study. Healthy adults were defined by medical history, physical examination and laboratory screening for HIV, HBV, HCV and intestinal parasitosis. Haematological parameters were measured using haematology analyzer MindrayBC320 (Mindray Biomedical electronic Corporation, China). CD4+Tcells were enumerated using FACS count (Becton Dickinson).The median age of the participants was 25 years. The overall median and 95th percentile of CD4+ T cells count were 869 cells/mm3 and396-1598 cells/mm3, respectively. Females had a significantly higher CD4+ T cell counts compared to males (P = 0.002). The 95th percentile range for red blood cells (RBCs) was 3.93-6.1 x 106cells/mm3and for hematocrit (Hct) was 40-58% while for hemoglobin (Hb) was 15.69-17.84g/dl. Males had significantly higher values of RBC and Hct than females (P < 0.001). Females (120-379 x 106 cells/mm3) had significantly higher platelet counts than males (106-352 x106 cells/mm3) (P < 0.001). The overall median of WBC was6.78 x103/mm3and its95thpercentile range was3.5-11.5 x103/mm3. The overall 95th percentile range of MCV, MCH and MCHC were 89.5-107.5 fl, 28-34 pg and 30-33.2g/dl, respectively. The higher mean absolute count of RBCs was found in the youngest age groups (P = 0.03). The mean count of RBCs and Hct were significantly higher in highschool completed and above than other participants (P < 0.001). The lower and upper limit of platelet counts was significantly higher in highland (118 -383x106 cells/mm3) compared to lowland residents (107-352 x106 cells/mm3) (P < 0.001). Moreover, it was significantly higher in residents with better monthly income (124-383 x106 cells/mm3) compared to the counters (115-368 x106 cells/mm3) (P = 0.02).Some of the haematological and CD4+ T cells reference ranges of the healthy adults in this study showed variations with the reference ranges used and reported so far in Ethiopia, Africa and Western countries. We recommend further study considering gender, altitude, and residency in other parts of Ethiopia to establish national reference ranges for Ethiopian population.

Project description:Important differences have been demonstrated in laboratory parameters from healthy persons in different geographical regions and populations, mostly driven by a combination of genetic, demographic, nutritional, and environmental factors. Despite this, European and North American derived laboratory reference intervals are used in African countries for patient management, clinical trial eligibility, and toxicity determination; which can result in misclassification of healthy persons as having laboratory abnormalities.An observational prospective cohort study known as the Kisumu Incidence Cohort Study (KICoS) was conducted to estimate the incidence of HIV seroconversion and identify determinants of successful recruitment and retention in preparation for an HIV vaccine/prevention trial among young adults and adolescents in western Kenya. Laboratory values generated from the KICoS were compared to published region-specific reference intervals and the 2004 NIH DAIDS toxicity tables used for the trial.About 1106 participants were screened for the KICoS between January 2007 and June 2010. Nine hundred and fifty-three participants aged 16 to 34 years, HIV-seronegative, clinically healthy, and non-pregnant were selected for this analysis. Median and 95% reference intervals were calculated for hematological and biochemistry parameters. When compared with both published region-specific reference values and the 2004 NIH DAIDS toxicity table, it was shown that the use of locally established reference intervals would have resulted in fewer participants classified as having abnormal hematological or biochemistry values compared to US derived reference intervals from DAIDS (10% classified as abnormal by local parameters vs. >40% by US DAIDS). Blood urea nitrogen was most often out of range if US based intervals were used: <10% abnormal by local intervals compared to >83% by US based reference intervals.Differences in reference intervals for hematological and biochemical parameters between western and African populations highlight importance of developing local reference intervals for clinical care and trials in Africa.

Project description:ObjectivePaediatric laboratory reference intervals used in Africa and Asia may be derived from historical intervals of predominantly Caucasian infants in Europe or North America. These intervals may therefore not be compatible with the range of normality for developing country populations. We aimed to compare haematology and biochemistry parameters in healthy South African infants with local laboratory reference intervals.MethodsWe compared the baseline haematology and biochemistry results of 634 (316 male and 318 female) HIV-unexposed infants, aged 3-6 months, living in a rural area of the Western Cape Province, South Africa, against laboratory reference intervals supplied by the South African National Health Laboratory Services (NHLS). We calculated the percentage of observed values out of bound (in terms of lower and upper limits) compared to laboratory reference intervals.ResultsOf the 634 healthy infants screened, 316 (49.84%) were male and 318 (50.16%) female. A majority (91.05%) had platelet counts above the laboratory reference interval upper limit (350 × 109 cells/l), while over half, 54.85% and 56.98% had mean corpuscular volume (MCV) and mean corpuscular haemoglobin (MCH) values below the lower limits of 77.0-105.0 fl and 26.0-34.0 pg, respectively. A small proportion were outside the reference limits for haematocrit, namely 15.71% below and 7.14% above the normal limits of 0.31-0.38 l/l. For male and female infants, 33.65% and 18.04% of alkaline phosphatase (ALP) values and 7.01% and 14.56% of alanine transaminase (ALT) values were above the upper limits, respectively. For male infants, 10.83% of gamma-glutamyl transferase (GGT) values, and for female infants, 31.11% of GGT values were below the lower limits of 12 U/l for males and 15 U/l for females. We observed no significant deviations (>10% out of bound) from NHLS reference intervals in the remaining haematology and biochemistry parameters measured.ConclusionsHaematology and biochemistry parameters in apparently healthy South African infants deviate frequently from national laboratory reference intervals, including abnormalities consistent with subclinical hypochromic microcytic anaemia. It is important that clinical laboratory reference intervals for children are derived locally, rather than being adopted from Caucasian norms in developed countries, because clinical trials of vaccines, drugs and diagnostics are increasingly conducted in sub-Saharan Africa.

Project description:Pangolins are the world's most trafficked non-human mammals. A significant number of Temminck's pangolins (Smutsia temminckii) are presented for veterinary care and rehabilitation in southern Africa. Little is known about the physiology and normal health of this species, making diagnosis and medical management difficult. This study aimed to establish reference intervals (RIs) for hematology and plasma clinical chemistry in the Temminck's pangolin. RIs were generated according to international guidelines using samples from 27 healthy free-living (n = 18) and rehabilitated (n = 9) pangolins. Hematology was performed using the Abaxis VetScan HM5 analyzer with manual differentials; clinical chemistry was performed using heparin plasma on the Abaxis VetScan VS2 and Cobas Integra 400 Plus analyzers. Hematology RIs were: RBC 3.88-8.31 × 1012/L, HGB 73-150 g/L, HCT 26-51%, MCV 59-72 fL, MCH 15.6-21.4 pg, MCHC 257-325 g/L, RDW 14.3-19.1%, WBC 1.80-10.71 × 109/L. Vetscan VS2 clinical chemistry RIs were: albumin 27-41 g/L, ALP 26-100 U/L, ALT 25-307 U/L, amylase 267-826 U/L, bilirubin 4-10 μmol/L, calcium 2.1-2.2 mmol/L, globulin 21-55 g/L, glucose 3.8-10.0 mmol/L, phosphate 1.3-2.6 mmol/L, potassium 3.6-5.9 mmol/L, sodium 132-140 mmol/L total protein 52-84 g/L, and urea 5.3-11.4 mmol/L. RIs for creatinine were not calculated as analytical imprecision exceeded analytical performance goals. Cobas Integra clinical chemistry RIs were: albumin 22-33 g/L, ALP 20-104 U/L, ALT 17-291 U/L, amylase 466-1,533 U/L, bilirubin 1-14 μmol/L, calcium 2.0-2.4 mmol/L, creatinine <58 μmol/L, globulin 23-49 g/L, glucose 3.6-10.1 mmol/L, phosphate 1.0-2.2 mmol/L, potassium 3.1-5.8 mmol/L, sodium 137-150 mmol/L, total protein 47-72 g/L, and urea 6.0-12.5 mmol/L. There was significant bias between the two chemistry analyzers for several measurands. Differences were found for some analytes between free-living and rehabilitated animals, probably reflecting differences in nutrition and hydration. These are the first RIs generated for Temminck's pangolin. These results will allow veterinarians to better determine pangolin health status, formulate optimal treatment plans and increase patient survival rates in this endangered species.

Project description:Most UK hospitals, laboratories, and research institutions use uniform reference intervals (RI) that do not take into account known diurnal and racial variation in total white blood cells (WBC) count and its constituent parameters. These risks of excluding potentially suitable ethnic minority volunteers from participating in phase I clinical trials could call into question the validity of a trial's findings or limit its scientific applications and ability to accurately observe drug effects upon WBC parameters. This study pools data from multiple phase I trials, assesses the effects of race and time of day on WBC count, and compares it to the existing literature to establish race and time-specific RIs. A total 13,332 venous blood samples obtained from 7,157 healthy male and female volunteers at the time of screening or admission (predosing) who took part in 35 phase I trials over a period of seven years were pooled and the data were analyzed using generalised estimating equation models. Adjusted RI of total WBC count and its individual parameters were then calculated according to time of day (morning vs. evening) for both black and nonblack populations. This study indicates that black individuals on average had lower total WBC, neutrophil, monocyte, eosinophil, and basophil counts than individuals from nonblack racial groups. Black volunteers had higher mean lymphocyte counts relative to their nonblack counterparts. These differences were deemed statistically significant. Statistically significant increases in total WBC, neutrophil, lymphocyte, and monocyte counts were also observed over the course of daily sampling. Eosinophil counts decreased during this time period, but this finding was only statistically significant in the nonblack population. Despite an observed mild diurnal increase in basophil count in both populations, this was not considered statistically significant. This high-powered study adds significant weight to the known evidence for diurnal and racial variation in WBC parameters. Importantly, it proposes specific RIs that more precisely reflect race and time of day. These could ensure increased participation of black volunteers in clinical trials for improved population representation. Furthermore, the proposed RIs allow for more accurate postdose safety monitoring and reporting, and ensure improved monitoring of postdose WBC count changes.

Project description:BackgroundHematological reference intervals are important in clinical and diagnostic management for the assessment of health and disease conditions. Hematological reference intervals are better to be established based on gender and age differences as these are among the main affecting factors.ObjectiveThe aim of this study was to establish hematological reference intervals among apparently healthy adolescents aged 12-17 years in Mekelle City, Tigrai, Northern Ethiopia, 2019.MethodA community-based cross-sectional study was conducted in 249 adolescents aged 12-17 years from December 2018 to May 2019. About 4ml of blood sample was collected from each study participant using vacutainer tube containing K2EDTA. Hematological parameters were analyzed using Sysmex KX-21N hematology analyzer (Sysmex Corporation Kobe, Japan). Data were entered and analyzed using SPSS version 23. Both parametric and non-parametric analyses were used to calculate the median and 95% of reference intervals. The 97.5th and 2.5th percentiles were calculated using descriptive statistics for the upper and lower reference limits of the study participants. Differences in reference intervals between male and female participants were evaluated using the Mann-Whitney U test.ResultAmong the 249 participants 122 (49%) were males and 127 (51%) were females with the median age of 14.5 (range 12 to 17) years were recruited in this study. The median and the 95% reference intervals of hematological parameters were determined. The 95% RIs were: Red blood cells (1012/Liter) 4.6-5.9 (Males) and 4.3-5.6 (Females), White blood cells (109/Liter) 2.9-9.6 (Males) and 3.4-10.2 (Females), Hemoglobin (g/dl) 12.6-17.1 (Males) and 12-15.4 (Females), Platelets (109/Liter) 138-364 (Males) and 151-462 (Females). Almost all of the hematological parameters showed significant differences (p<0.05) across gender.ConclusionThe hematological reference intervals established in this study showed a difference based on gender. We suggest preparing and using distinct local reference intervals for males and females separately.

Dataset Information

Reference intervals for selected haematological and biochemical parameters among apparently healthy adults in different eco-geographical zones in Ghana.

Background

Methods

Results

Conclusion

Publications

Reference intervals for selected haematological and biochemical parameters among apparently healthy adults in different eco-geographical zones in Ghana.

Similar Datasets

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