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 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.

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 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 Specific Reference Intervals of Serum Triiodothyronine, Thyroxine, and Thyroid-stimulating Hormone in Normal Pregnant Indian Women as per Trimester

2017 ◽  
Vol 21 (1) ◽  
pp. 17-21
Author(s):  
Nandita Hazra ◽  
Binay Mitra ◽  
Reetika Pal
Keyword(s):  
Thyroid Hormone ◽  
Pregnant Women ◽  
Reference Intervals ◽  
Thyroid Stimulating Hormone ◽  
Specific Reference ◽  
Indian Women ◽  
Hormone Levels ◽  
Thyroid Hormone Levels ◽  
Maternal Thyroid ◽  
Stimulating Hormone

ABSTRACT Aim Maternal thyroid hormone levels during pregnancy are vital for the health of the mother as well as the developing child. Fetal growth is affected by maternal thyroid levels. Various physiological changes like alterations of thyroxine-binding globulins, human chorionic gonadotropin level, and changes in iodide metabolism affect maternal thyroid hormone levels. Therefore, reference intervals (RIs) for thyroid hormones in pregnant population require to be established separately from the general population. Materials and methods The RIs of serum triiodothyronine (T3), thyroxine (T4), and thyroid-stimulating hormone (TSH) were determined in healthy pregnant women by enzyme-linked immunosorbent assay (ELISA) technique after segregating them into three trimesters. This study was conducted in a 492-bedded zonal-level hospital. The reference population was chosen from a study population of pregnant women by strict inclusion and exclusion criteria. The assays were done by the most-commonly used, economical ELISA method employing standard kits. Tests were done using accurate and precise methods with proper quality control measures. Results The RIs were calculated from the central 95% of distribution of total T3, total T4, and TSH values located between 2.5 and 97.5 percentile values. The 0.90 confidence intervals for the upper and lower reference limits were calculated. The values thus obtained were different from those provided by the manufacturer kit literature. Conclusion It is recommended to determine one's own laboratory-specific, method-specific, trimester-wise RIs for maternal thyroid hormone status and use them for screening of pregnant women. How to cite this article Chakrabarty BK, Mitra B, Pal R, Hazra N. Specific Reference Intervals of Serum Triiodothyronine, Thyroxine, and Thyroid-stimulating Hormone in Normal Pregnant Indian Women as per Trimester. Indian J Med Biochem 2017;21(1):17-21.

scholarly journals First Estimation of Reference Intervals for Thyroid-Stimulating Hormone and Thyroid Hormones in Slovenian Population

2021 ◽  
Vol 68 (2) ◽  
pp. 488-493
Author(s):  
Adrijana Oblak ◽  
Ajda Biček ◽  
Edvard Pirnat ◽  
Katja Zaletel ◽  
Simona Gaberšček
Keyword(s):  
Thyroid Hormones ◽  
Thyroid Disease ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Reference Intervals ◽  
Thyroid Stimulating Hormone ◽  
Healthy Individuals ◽  
Free Triiodothyronine ◽  
Percentile Method ◽  
Stimulating Hormone

For thyroid function estimation and clinical decision making, use of appropriate reference intervals for thyroid-stimulating hormone (TSH), free thyroxine (fT4) and free triiodothyronine (fT3) is crucial. For each laboratory, establishment of own reference intervals is advised. For the first Slovenian estimation of reference intervals for thyroid hormones a large group of 1722 healthy individuals without thyroid disease was established retrospectively. Hormone analyses were performed on automated analyser Advia Centaur XP Immunoassay System (Siemens Healthineers), which reference intervals for TSH, fT4 and fT3 were 0.55–4.78 mIU/L, 11.5–22.7 pmol/L, and 3.5–6.5 pmol/L, respectively. Statistical analysis followed non-parametric percentile method. Our laboratory reference intervals for TSH, fT4 and fT3 are mostly narrower than intervals given by manufacturer. Median value, lower and upper limit for TSH, fT4 and fT3 were 1.98 (0.59–4.23) mIU/L, 14.5 (11.3–18.8) pmol/L and 4.82 (3.79–6.05) pmol/L, respectively. Most likely, an inclusion of a high number of healthy individuals without thyroid disease was a reason for such results.

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.

Establishment of trimester-specific thyroid stimulating hormone and free thyroxine reference interval in pregnant Chinese women using the Beckman Coulter UniCel™ DxI 600

2015 ◽  
Vol 53 (9) ◽  
Author(s):  
Jing Zhang ◽  
Wei Li ◽  
Qiao-Bin Chen ◽  
Li-Yi Liu ◽  
Wei Zhang ◽  
...  
Keyword(s):  
Chinese Women ◽  
Reference Interval ◽  
Reference Intervals ◽  
Thyroid Stimulating Hormone ◽  
Free Thyroxine ◽  
Specific Reference ◽  
Thyroid Peroxidase ◽  
Cross Sectional ◽  
Reported Data ◽  
Stimulating Hormone

AbstractThyroid-stimulating hormone (TSH) and free thyroxine (FT4) reference intervals are essential for screening and diagnosing thyroid dysfunction during pregnancy. The aim of this study was to establish method- and trimester-specific TSH and FT4 reference intervals in pregnant Chinese women using the Beckman Coulter UniCel™ DxI 600.A cross-sectional dataset analysis was performed. A total of 3507 participants were recruited, and 2743 were eligible for analysis to set reference intervals. TSH, FT4, and thyroid peroxidase antibody (TPOAb) levels were analyzed with the Beckman Coulter UniCel™ DxI 600 AccessThe calculated reference intervals for the first, second, and third trimesters were TSH: 0.06–3.13, 0.07–4.13 and 0.15–5.02 mIU/L, respectively, and FT4: 8.72–15.22, 7.10–13.55 and 6.16–12.03 pmol/L, respectively.Our reference intervals for TSH and FT4 are distinct from the ranges reported in the DxI 600 instruction manual and previously reported data, confirming the importance of method-specific reference intervals.

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