Paediatric reference intervals for 17 Roche cobas 8000 e602 immunoassays in the CALIPER cohort of healthy children and adolescents

2019 ◽  
Vol 57 (12) ◽  
pp. 1968-1979 ◽  
Author(s):  
Mary Kathryn Bohn ◽  
Victoria Higgins ◽  
Shervin Asgari ◽  
Felix Leung ◽  
Barry Hoffman ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Reference Values ◽  
Laboratory Tests ◽  
Clinical Decision Making ◽  
Reference Intervals ◽  
Healthy Children ◽  
Serum Samples ◽  
Clinical Laboratories ◽  
Age And Sex ◽  
Roche Cobas

Abstract Background The diagnostic utility of laboratory tests in paediatric medicine relies heavily on the availability of appropriate reference intervals (RIs). The Canadian Laboratory Initiative on Paediatric Reference Intervals (CALIPER) has established a comprehensive database of covariate-stratified RIs for many paediatric laboratory tests using a large, healthy reference population. Several automated analysers in widespread use in clinical laboratories have already been studied. Here, we extend the testing to Roche immunoassays and report, for the first time, comprehensive paediatric RIs for 17 endocrine and special chemistry markers. Methods A total of 741 healthy children and adolescents (1 day to <19 years) were recruited and serum samples were analysed for 17 immunoassays on the Roche cobas 8000 e602 Immunoassay Analyzer. Age and sex-specific RIs were established and corresponding 90% confidence intervals (CIs) were calculated in accordance with Clinical and Laboratory Standards Institute guidelines. Results Reference values for all analytes measured required age partitioning, particularly during early life and throughout adolescence. Of the 17 analytes measured, eight required sex partitioning, including ferritin, thyroid stimulating hormone (TSH), total triiodothyronine (TT3) and all fertility/sex hormones, except prolactin. Conclusions This is the first study to determine accurate paediatric RIs for Roche immunoassays. RIs were generally similar to those previously published by CALIPER on other analytical platforms, highlighting the reproducibility of age- and sex-specific trends in reference values observed across the paediatric age range. The RIs established in this study will improve the accuracy of test result interpretation and clinical decision-making in clinical laboratories utilising Roche immunoassays.

Pediatric reference intervals for endocrine markers and fertility hormones in healthy children and adolescents on the Siemens Healthineers Atellica immunoassay system

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mary Kathryn Bohn ◽  
Paul Horn ◽  
Donna League ◽  
Paul Steele ◽  
Alexandra Hall ◽  
...  
Keyword(s):  
Clinical Decision Making ◽  
Rapid Development ◽  
Reference Intervals ◽  
Thyroid Stimulating Hormone ◽  
Specific Reference ◽  
Childhood And Adolescence ◽  
Healthy Children ◽  
Serum Samples ◽  
Age And Sex ◽  
Stimulating Hormone

Abstract Objectives Rapid development in childhood and adolescence combined with lack of immunoassay standardization necessitates the establishment of age-, sex-, and assay-specific reference intervals for immunochemical markers. This study established reference intervals for 11 immunoassays on the new Siemens Healthineers Atellica® IM Analyzer in the healthy CALIPER cohort. Methods A total of 600 healthy participants (birth to 18 years) were recruited from the community, and serum samples were collected with informed consent. After sample analysis, age- and sex-specific differences were assessed, and outliers were removed. Reference intervals were established using the robust method (40–<120 participants) or nonparametric method (≥120 participants). Results Of the 11 immunoassays studied, nine required age partitioning (i.e., dehydroepiandrosterone-sulfate, estradiol, ferritin, folate, follicle-stimulating hormone, luteinizing hormone, progesterone, testosterone, vitamin B12), and seven required sex partitioning. Free thyroxine and thyroid-stimulating hormone demonstrated no significant age- and/or sex-specific differences. Conclusions Overall, the age- and sex-specific trends observed closely mirrored those previously reported by CALIPER on other platforms as well as other internationally recognized studies. However, established lower and upper limits demonstrated some discrepancies between published values from healthy cohorts on alternate analytical systems, highlighting differences between manufacturers and the need for platform-specific reference intervals for informed pediatric clinical decision-making.

scholarly journals Folate and Cobalamin Serum Levels in Healthy Children and Adolescents and Their Association with Age, Sex, BMI and Socioeconomic Status

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 546
Author(s):  
Paulina Kreusler ◽  
Mandy Vogel ◽  
Anja Willenberg ◽  
Ronny Baber ◽  
Yvonne Dietz ◽  
...  
Keyword(s):  
Socioeconomic Status ◽  
Children And Adolescents ◽  
Serum Levels ◽  
Population Based ◽  
Research Centre ◽  
Healthy Children ◽  
Serum Samples ◽  
Lms Method ◽  
Healthy Participants ◽  
Age And Sex

This study proposes age- and sex-specific percentiles for serum cobalamin and folate, and analyzes the effects of sex, age, body mass index (BMI), and socioeconomic status (SES) on cobalamin and folate concentrations in healthy children and adolescents. In total, 4478 serum samples provided by healthy participants (2 months–18.0 years) in the LIFE (Leipzig Research Centre for Civilization Diseases) Child population-based cohort study between 2011 and 2015 were analyzed by electrochemiluminescence immunoassay (ECLIA). Continuous age-and sex-related percentiles (2.5th, 10th, 50th, 90th, 97.5th) were estimated, applying Cole’s LMS method. In both sexes, folate concentrations decreased continuously with age, whereas cobalamin concentration peaked between three and seven years of age and declined thereafter. Female sex was associated with higher concentrations of both vitamins in 13- to 18-year-olds and with higher folate levels in one- to five-year-olds. BMI was inversely correlated with concentrations of both vitamins, whilst SES positively affected folate but not cobalamin concentrations. To conclude, in the assessment of cobalamin and folate status, the age- and sex-dependent dynamic of the respective serum concentrations must be considered. While BMI is a determinant of both vitamin concentrations, SES is only associated with folate concentrations.

Pediatric reference interval verification for endocrine and fertility hormone assays on the Abbott Alinity system

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mary Kathryn Bohn ◽  
Siobhan Wilson ◽  
Alexandra Hall ◽  
Khosrow Adeli
Keyword(s):  
Clinical Decision Making ◽  
De Novo ◽  
Reference Interval ◽  
Clinical Decision ◽  
Reference Intervals ◽  
Healthy Children ◽  
Confidence Limits ◽  
Test Results ◽  
Serum Samples ◽  
Abbott Architect

Abstract Objectives The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has developed an extensive database of reference intervals (RIs) for several biomarkers on various analytical systems. In this study, pediatric RIs were verified for key immunoassays on the Abbott Alinity system based on the analysis of healthy children samples and comparison to comprehensive RIs previously established for Abbott ARCHITECT assays. Methods Analytical performance of Alinity immunoassays was first assessed. Subsequently, 100 serum samples from healthy children recruited with informed consent were analyzed for 16 Alinity immunoassays. The percentage of test results falling within published CALIPER ARCHITECT reference and confidence limits was determined. If ≥ 90% of test results fell within the confidence limits, they were considered verified based on CLSI guidelines. If <90% of test results fell within the confidence limits, additional samples were analyzed and new Alinity RIs were established. Results Of the 16 immunoassays assessed, 13 met the criteria for verification with test results from ≥ 90% of healthy serum samples falling within the published ARCHITECT confidence limits. New CALIPER RIs were established for free thyroxine and prolactin on the Alinity system. Estradiol required special considerations in early life. Conclusions Our data demonstrate excellent concordance between ARCHITECT and Alinity immunoassays, as well as the robustness of previously established CALIPER RIs for most immunoassays, eliminating the need for de novo RI studies for most parameters. Availability of pediatric RIs for immunoassays on the Alinity system will assist clinical laboratories using this new platform and contribute to improved clinical decision-making.

Pediatric reference intervals for 1,25-dihydroxyvitamin D using the DiaSorin LIAISON XL assay in the healthy CALIPER cohort

2018 ◽  
Vol 56 (6) ◽  
pp. 964-972 ◽  
Author(s):  
Victoria Higgins ◽  
Dorothy Truong ◽  
Nicole M.A. White-Al Habeeb ◽  
Angela W.S. Fung ◽  
Barry Hoffman ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Critical Role ◽  
Reference Interval ◽  
Reference Intervals ◽  
Biologically Active ◽  
Specific Reference ◽  
Healthy Children ◽  
Serum Samples ◽  
Dihydroxyvitamin D ◽  
1,25 Dihydroxyvitamin D

Abstract Background: 1,25-dihydroxyvitamin D (1,25(OH)2D), the biologically active vitamin D metabolite, plays a critical role in calcium and phosphate homeostasis. 1,25(OH)2D is measured to assess calcium and phosphate metabolism, particularly during periods of profound growth and development. Despite its importance, no reliable pediatric reference interval exists, with those available developed using adult populations or out-dated methodologies. Using the fully automated chemiluminescence immunoassay by DiaSorin, we established 1,25(OH)2D pediatric reference intervals using healthy children and adolescents from the CALIPER cohort. Methods: Serum samples from healthy subjects (0 to <19 years) were analyzed for 1,25(OH)2D using the DiaSorin LIAISON XL assay and age-specific reference intervals were established. The Mann-Whitney U-test was used to determine seasonal differences. Pooled neonatal and infantile samples were quantified using liquid chromatography tandem mass spectrometry (LC-MS/MS) to determine if elevated concentrations during the first year of life may be attributed to cross-reacting moieties. Results: Three reference interval age partitions were required with highest levels in subjects 0 to <1 year (77–471 pmol/L), which declined and narrowed after 1 year (113–363 pmol/L) and plateaued at 3 years (108–246 pmol/L). 1,25(OH)2D concentration was not significantly affected by seasonal variation or sex. Elevated 1,25(OH)2D concentrations in neonatal and infantile samples may be the result of an interfering substance. The absence of 3-epi-1,25-dihydroxyvitamin D in the pooled samples makes it unlikely to be the interfering moiety. Conclusions: Pediatric reference intervals for 1,25(OH)2D were established to improve test result interpretation in children and adolescents. 1,25(OH)2D is elevated in a proportion of neonates and infants, which may be the result of a cross-reacting moiety.

scholarly journals Age- and sex-specific reference intervals for the serum cystatin C/creatinine ratio in healthy children (0–18 years old)

2019 ◽  
Vol 47 (7) ◽  
pp. 3151-3159 ◽  
Author(s):  
Changjin Liu ◽  
Jing Wen ◽  
Jialin Xiang ◽  
Xuhong Ouyang ◽  
Yan Yang ◽  
...  
Keyword(s):  
Cystatin C ◽  
Pediatric Population ◽  
Age Groups ◽  
Serum Markers ◽  
Reference Intervals ◽  
Specific Reference ◽  
Healthy Children ◽  
Serum Samples ◽  
Serum Cystatin C ◽  
Age And Sex

Objective This study aimed to investigate serum levels of the cystatin C (CysC)/creatinine (Cr) ratio and renal serum markers (CysC, Cr, urea, and uric acid [UA]) for different ages and by sex. We also aimed to establish pediatric reference intervals for the serum CysC/Cr ratio. Methods Serum samples were collected from 4765 healthy children (0–18 years old). Serum markers of renal function were measured, and the CysC/Cr ratio of each participant was calculated and statistically analyzed. Results The renal marker CysC did not substantially change after 1 year old. Cr, urea, and UA levels generally increased with age. However, the serum CysC/Cr ratio steadily decreased with age. The CysC/Cr ratio showed significant differences in age among all age groups and varied with sex, except for in the 1 to 6-year-old groups. The overall serum CysC/Cr ratio in girls was higher than that in boys. Conclusion Reference intervals of the serum CysC/Cr ratio in the pediatric population were established. These intervals need to be partitioned by age and sex.

Influence of ethnicity on biochemical markers of health and disease in the CALIPER cohort of healthy children and adolescents

2020 ◽  
Vol 58 (4) ◽  
pp. 605-617 ◽  
Author(s):  
Houman Tahmasebi ◽  
Shervin Asgari ◽  
Alexandra Hall ◽  
Victoria Higgins ◽  
Ashfia Chowdhury ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Clinical Decision Making ◽  
Pediatric Population ◽  
Statistical Significance ◽  
Immunoglobulin A ◽  
Clinical Decision ◽  
Reference Intervals ◽  
Immunoglobulin M ◽  
Healthy Children ◽  
Pediatric Study

AbstractBackgroundAccurate pediatric reference intervals (RIs) for laboratory tests determined in a healthy pediatric population are essential for correct laboratory test interpretation and clinical decision-making. In pediatrics, RIs require partitioning by age and/or sex; however, the need for partitioning based on ethnicity is unclear. Here, we assessed the influence of ethnicity on biomarker concentrations in the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort of healthy children and adolescents and compared the results with the National Health and Nutrition Examination Survey (NHANES).MethodsA total of 52 biomarkers were measured in a multiethnic population of 846–1179 healthy children (aged 5 to <19 years) upon informed consent. Biomarker concentrations were retrospectively compared between four major ethnic groups (i.e. Black, Caucasian, East Asian, and South Asian, determined by parental ethnicity). Retrospective results were verified prospectively using an additional 500 healthy pediatric samples with equal sample size across ethnicities. Ethnic-specific differences were assessed based on statistical significance and biological and analytical variations. Appropriate age-, sex-, and ethnic-specific RIs were calculated.ResultsEthnic-specific differences were not observed for 34 biomarkers examined in the retrospective analysis, while 18 demonstrated statistically significant ethnic differences. Among these, seven analytes demonstrated ethnic-specific differences in the prospective analysis: vitamin D, amylase, ferritin, follicle-stimulating hormone (FSH), immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM). Analysis of select NHANES data confirmed CALIPER findings.ConclusionsThis is the first comprehensive Canadian pediatric study examining ethnic-specific differences in common biomarkers. While the majority of biomarkers did not require ethnic partitioning, ethnic-specific RIs were established for seven biomarkers showing marked differences. Further studies in other populations are needed to confirm our findings.

Reference Values for Immunoglobulin Kappa and Lambda Light Chains and the Kappa/Lambda Ratio in Children's Serum

1992 ◽  
Vol 38 (12) ◽  
pp. 2454-2457 ◽  
Author(s):  
M Saitta ◽  
A Iavarone ◽  
N Cappello ◽  
M R Bergami ◽  
G C Fiorucci ◽  
...  
Keyword(s):  
Immune System ◽  
Children And Adolescents ◽  
Reference Values ◽  
Light Chains ◽  
Healthy Children ◽  
Serum Samples ◽  
Immunoglobulin Synthesis ◽  
Immunoglobulin Kappa

Abstract We analyzed 708 serum samples from healthy children and adolescents by immunonephelometry to obtain reference values for the immunoglobulin kappa (kappa) and lambda (lambda) light chains and for their ratio at a time of life when immunoglobulin synthesis is maturing and continually being stimulated. The lambda chain concentration that is to be maintained throughout the child's life is reached very early, just after 1 year, whereas the concentration of the kappa chains, which increases gradually, reflects the concentration of the immunoglobulins as a whole. These reference values may be useful for studying kappa and lambda chains in illnesses involving the immune system in children.

Pediatric Reference Intervals for Ten Coagulation Assays.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2988-2988 ◽  
Author(s):  
Michele M. Flanders ◽  
Ronda A. Crist ◽  
William M. Roberts ◽  
George M. Rodgers
Keyword(s):  
Lower Limit ◽  
Reference Values ◽  
Laboratory Tests ◽  
Clinical Laboratory ◽  
Protein S ◽  
Reference Intervals ◽  
Health Improvement ◽  
Laboratory Diagnostics ◽  
Healthy Children ◽  
Coagulation Proteins

Abstract There is a lack of reliable pediatric reference intervals for many clinical laboratory tests. In 2002, the Children’s Health Improvement through Laboratory Diagnostics (CHILDx) organization initiated a project to collect blood and urine samples from healthy children 7 – 17 years of age with the goal of establishing reference intervals for many laboratory tests. The purpose of the present study was to determine pediatric reference intervals for ten coagulation proteins associated with common bleeding and thrombotic disorders. All assays were functional except for vonWillebrand factor antigen. All were measured according to manufacturer specifications and standard methods using the STA-R coagulation analyzer (Diagnostica Stago), with the exception of the ristocetin cofactor assay, which was performed on the BCS (Dade Behring). Samples used to establish adult reference intervals were purchased from George King Bio-Medical, Precision Biologic, and also drawn in-house. At each age of life, 62 individuals (31 girls/31 boys) were drawn for a minimum of 124 individuals for each age group. Reference intervals were established based on a nonparametric method (NCCLS C28-A). RESULTS: 1. Although pediatric PTT values do not differ from adult values, the mean pediatric PT values are about 1 sec longer, 2. Pediatric FIX levels trend upward until ages 16-17 when adult levels are reached, 3. FVIII, FXI, RCF and vWFAg demonstrate higher reference values in younger ages, 4. The lower limit of pediatric AT levels is significantly higher than adults, 5. The lower limit of pediatric protein C levels is significantly lower than adults, however, this difference is not seen for protein S levels. In conclusion, a number of significant differences between pediatric and adult reference intervals have been found supporting the use of these newer reference intervals. Age N PT PTT F VIII F IX F XI 7–9 186 13.1–15.4* 27–38 78–199* 71–138* 70–138 10–11 124 12.9–15.5* 27–38 83–226* 72–159* 63–137 12–13 124 13.1–15.2* 27–38 74–205* 73–152* 65–130* 14–15 124 12.9–15.4* 26–35 69–241* 80–162 57–125* 16–17 121 12.6–15.9* 26–35 63–225* 85–175 64–160 Adult 125 12.3–14.4 26–38 56–190 78–184 56–153 Age AT RCF VWF Ag PC PS-Male PS-Female * The t-test of the means, F-test of the SD, or both is statistically different (p&lt; 0.05) from adult reference values. 7–9 96–135* 51–172* 62–176 71–143* 64–141 58–154 10–11 92–134* 61–195* 61–201* 76–146* 68–150 68–140* 12–13 92–128* 47–183* 61–186* 68–162* 65–143 60–150 14–15 95–135* 50–215* 57–204* 69–170* 66–149 53–147* 16–17 94–131* 47–206* 51–211 70–170* 75–157* 51–150* Adult 76–128 44–195 51–185 83–168 66–143 57–131

scholarly journals CALIPER Hematology Reference Standards (II)

2020 ◽  
Vol 154 (3) ◽  
pp. 342-352 ◽  
Author(s):  
Victoria Higgins ◽  
Houman Tahmasebi ◽  
Mary Kathryn Bohn ◽  
Alexandra Hall ◽  
Khosrow Adeli
Keyword(s):  
Children And Adolescents ◽  
Hemoglobin Concentration ◽  
Reference Intervals ◽  
Reference Standards ◽  
Reference Database ◽  
Specific Reference ◽  
Mean Corpuscular Hemoglobin ◽  
Healthy Children ◽  
Cell Percentage ◽  
Age And Sex

Abstract Objectives The objective of this study was to establish comprehensive age- and sex-specific reference intervals for hematologic parameters in the CALIPER cohort of healthy children and adolescents. Methods A total of 536 healthy children and adolescents (birth to 21 years) were recruited with informed consent, and whole blood samples were analyzed for 27 hematologic parameters on the Beckman Coulter DxH 520 system. Age- and sex-specific pediatric reference standards were established. Reference values obtained on the DxH 520 were also compared with data obtained on a larger laboratory-based instrument (DxH 900). Results Most hematologic parameters showed significant age- and/or sex-specific changes during growth and development. Of the 27 hematologic parameters, all except four (mean corpuscular hemoglobin concentration, basophil percentage, low hemoglobin density, immature cell percentage) required age partitioning, and eight required sex partitioning. Conclusions This study establishes a robust pediatric hematology reference database that will assist in more accurate test result interpretation. Our data clearly demonstrate significant variation in hematologic parameter concentrations in children and adolescents, necessitating the use of pediatric-specific reference standards.

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