Dataset Information

A prospective, cross-sectional study to establish age-specific reference intervals for neonates and children in the setting of clinical biochemistry, immunology and haematology: the HAPPI Kids study protocol.

ABSTRACT:

Introduction

The clinical interpretation of laboratory tests is reliant on reference intervals. However, the accuracy of a reference interval is dependent on the selected reference population, and in paediatrics, the ability of the reference interval to reflect changes associated with growth and age, as well as sex and ethnicity. Differences in reagent formulations, methodologies and analysers can also impact on a reference interval. To date, no direct comparison of reference intervals for common analytes using different analysers in children has been published. The Harmonising Age Pathology Parameters in Kids (HAPPI Kids) study aims to establish age-appropriate reference intervals for commonly used analytes in the routine clinical care of neonates and children, and to determine the feasibility of paediatric reference interval harmonisation by comparing age-appropriate reference intervals in different analysers for multiple analytes.

Methods and analysis

The HAPPI Kids study is a prospective cross-sectional study, collecting paediatric blood samples for analysis of commonly requested biochemical, immunological and haematological tests. Venous blood samples are collected from healthy premature neonates (32-36 weeks of gestation), term neonates (from birth to a maximum of 72?hours postbirth) and children aged 30 days to ?18 years (undergoing minor day surgical procedures). Blood samples are processed according to standard laboratory procedures and, if not processed immediately, stored at -80°C. A minimum of 20 samples is analysed for every analyte for neonates and then each year of age until 18 years. Analytical testing is performed according to the standard operating procedures used for clinical samples. Where possible, sample aliquots from the same patients are analysed for an analyte across multiple commercially available analysers.

Ethics and dissemination

The study protocol was approved by The Royal Children's Hospital, Melbourne, Ethics in Human Research Committee (34183 A). The study findings will be published in peer-reviewed journals and shared with clinicians, laboratory scientists and laboratories.

SUBMITTER: Hoq M

PROVIDER: S-EPMC6500200 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Publications

A prospective, cross-sectional study to establish age-specific reference intervals for neonates and children in the setting of clinical biochemistry, immunology and haematology: the HAPPI Kids study protocol.

Hoq Monsurul M Karlaftis Vicky V Mathews Susan S Burgess Janet J Donath Susan M SM Carlin John J Monagle Paul P Ignjatovic Vera V

BMJ open 20190403 4

<h4>Introduction</h4>The clinical interpretation of laboratory tests is reliant on reference intervals. However, the accuracy of a reference interval is dependent on the selected reference population, and in paediatrics, the ability of the reference interval to reflect changes associated with growth and age, as well as sex and ethnicity. Differences in reagent formulations, methodologies and analysers can also impact on a reference interval. To date, no direct comparison of reference intervals f ...[more]

PMID: 30948591

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Project description:Reference intervals (RIs) are an increasingly valuable tool for monitoring captive and free-living wildlife populations. Galapagos tortoises are one of the most emblematic species on Earth with 9 of the 12 extant species considered endangered due to human activities. As part of a long-term health assessment within the Galapagos Tortoise Movement Ecology Programme, we sampled a total of 210 free-living Santa Cruz Galapagos tortoises (Chelonoidis porteri). We collected blood from the brachial vein and performed packed cell volume (PCV), total solids (TS), morphological evaluation, white blood cell (WBC) count estimates and differentials and a VetScan biochemistry panel for each individual. We calculated 95% RIs and 90% confidence intervals (CIs) using the Reference Value Advisor tool and following international standard guidelines. Tortoises were categorized by estimated age and sex, with RI and CI reported here for 164 adult tortoises and 46 sub-adult tortoises. We found significant differences between sexes, with adult females presenting a lower PCV and higher values for both calcium and potassium. Among age groups, adult tortoises presented higher PCV, TS and albumin and lower WBC counts, aspartate aminotransferase and creatine kinase than sub-adult tortoises. We also found that tortoises presented higher numbers of lymphocytes during the dry season, but higher basophils, eosinophils, phosphorus, potassium and TS during the humid season. The heterophil:lymphocyte ratio did not differ between groups. To the authors' knowledge, this is the first report of formal plasma biochemistry and haematology RI for free-living Galapagos tortoises. With the present study we provide an important diagnostic tool for captive-breeding programs in the Galapagos and zoological institutions globally that care for giant tortoises. The ultimate goal of this study is to contribute to the understanding of giant tortoise baseline health parameters and to inform local management decisions that help to conserve these emblematic species.

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Project description:The American crocodile (Crocodylus acutus) is considered a vulnerable species by the International Union for Conservation of Nature (IUCN) Red List across its range and classified as locally threatened in several countries. There is a lack of knowledge involving hematological and physiological parameters in American crocodile populations, limiting our understanding of what are considered "normal" blood analyte results for the species and how to link them with health assessments. In this study, we analyzed 40 hematological and biochemical parameters and estimated reference intervals (RIs) for 35 of them based on 436 clinically healthy wild American crocodiles caught in South Florida between 2015 and 2021. Crocodiles were captured across three areas with different levels of human influence [low = Everglades National Park (ENP), medium = Biscayne Bay Estuary (BBE), and high = Turkey Point Nuclear Power Plant (TP)]. There was very strong-to-strong evidence for an effect of where animals were caught on five analytes: basophils %, phosphorus, proportion of (pr) alpha-2 globulins, absolute count (abs) of gamma globulins, and corticosterone, so no reference values were estimated but general statistics are presented and discussed. From the remaining analytes, we found no evidence that sex or size class had an effect on red blood cell (RBC), azurophils and monocytes abs, triglycerides, and albumin abs. However, we did find moderate-to-strong evidence that sex influenced azurophils % and size class influenced white blood cell (WBC), heterophils %, monocytes %, basophils abs, creatine phosphokinase (CPK), potassium, glucose, bile acids, alpha-1 globulin abs, and alpha-2 globulin pr and abs. Finally, there was strong evidence that both sex and size class influenced PCV, lymphocytes % and abs, eosinophils % and abs, aspartate aminotransferase (AST), calcium, sodium, chloride, total protein, albumin/globulin (A/G) ratio, albumin pr, alpha-1 globulin, and beta globulin abs. Intraspecific analysis showed that size is the variable that most influenced analytes explaining up to 29% of the variation, which relates to our findings based on intraindividual analysis. We compared our results with blood parameters reported for conspecifics as well as closely related species and discussed implication of those results for clinical diagnosis and American crocodile conservation.

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.

Dataset Information

A prospective, cross-sectional study to establish age-specific reference intervals for neonates and children in the setting of clinical biochemistry, immunology and haematology: the HAPPI Kids study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Publications

A prospective, cross-sectional study to establish age-specific reference intervals for neonates and children in the setting of clinical biochemistry, immunology and haematology: the HAPPI Kids study protocol.

Similar Datasets

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