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  • 1
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    Online Resource
    CALIPER Hematology Reference Standards (I)
    Oxford University Press (OUP) ; 2020
    In:  American Journal of Clinical Pathology Vol. 154, No. 3 ( 2020-08-05), p. 330-341
    Details
    In: American Journal of Clinical Pathology, Oxford University Press (OUP), Vol. 154, No. 3 ( 2020-08-05), p. 330-341
    Abstract: Accurate hematologic test interpretation based on normative reference standards is critical to ensure appropriate clinical decision making. However, healthy pediatric reference data for most hematology parameters are lacking. To address this gap, this study establishes age- and sex-specific hematologic reference standards in the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort of healthy children and adolescents. Methods Fresh whole blood samples collected from a total of 566 healthy children and adolescents (birth to & lt;21 years) with informed consent were analyzed for 47 hematologic parameters on the Beckman Coulter DxH 900. Age- and sex-specific reference standards were calculated based on the Clinical and Laboratory Standards Institute guidelines. Results Reference value distributions for most hematology parameters demonstrated dynamic changes across the pediatric age range with significant age-specific differences observed for 39 of the 47 parameters examined. Sex-specific differences were also observed for eight hematologic parameters, primarily during and after puberty. Conclusions This study establishes a robust database of pediatric reference standards for 47 hematologic parameters in the CALIPER cohort for the first time. These comprehensive reference value data sets report potentially important and physiologically relevant trends in hematologic markers, clearly demonstrating the need for pediatric reference standards for hematologic test interpretation.
    Type of Medium: Online Resource
    ISSN: 0002-9173 , 1943-7722
    URL: Article
    DOI: 10.1093/ajcp/aqaa059
    RVK:
    YV 2000
    RVK:
    XA 18700
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
    detail.hit.zdb_id: 2039921-2
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  • 2
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    Mining the Gap: Deriving Pregnancy Reference Intervals for Hematology Parameters Using Clinical Datasets
    Oxford University Press (OUP) ; 2023
    In:  Clinical Chemistry Vol. 69, No. 12 ( 2023-12-01), p. 1374-1384
    Details
    In: Clinical Chemistry, Oxford University Press (OUP), Vol. 69, No. 12 ( 2023-12-01), p. 1374-1384
    Abstract: Physiological changes during pregnancy invalidate use of general population reference intervals (RIs) for pregnant people. The complete blood count (CBC) is commonly ordered during pregnancy, but few studies have established pregnancy RIs suitable for contemporary Canadian mothers. Prospective RI studies are challenging to perform during pregnancy while retrospective techniques fall short as pregnancy and health status are not readily available in the laboratory information system (LIS). This study derived pregnancy RIs retrospectively using LIS data linked to provincial perinatal registry data. Methods A 5-year healthy pregnancy cohort was defined from the British Columbia Perinatal Data Registry and linked to laboratory data from two laboratories. CBC and differential RIs were calculated using direct and indirect approaches. Impacts of maternal and pregnancy characteristics, such as age, body mass index, and ethnicity, on laboratory values were also assessed. Results The cohort contained 143 106 unique term singleton pregnancies, linked to & gt;972 000 CBC results. RIs were calculated by trimester and gestational week. Result trends throughout gestation aligned with previous reports in the literature, although differences in exact RI limits were seen for many tests. Trimester-specific bins may not be appropriate for several CBC parameters that change rapidly within trimesters, including red blood cells (RBCs), some leukocyte parameters, and platelet counts. Conclusions Combining information from comprehensive clinical databases with LIS data provides a robust and reliable means for deriving pregnancy RIs. The present analysis also illustrates limitations of using conventional trimester bins during pregnancy, supporting use of gestational age or empirically derived bins for defining CBC normal values during pregnancy.
    Type of Medium: Online Resource
    ISSN: 0009-9147 , 1530-8561
    URL: Article
    DOI: 10.1093/clinchem/hvad167
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 3
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    DataSheet1.PDF
    Frontiers Media SA ; 2021
    In:  Frontiers in Molecular Biosciences Vol. 8 ( 2021-12-16)
    Details
    In: Frontiers in Molecular Biosciences, Frontiers Media SA, Vol. 8 ( 2021-12-16)
    Abstract: Introduction: The major clinical problem presently confronting the Chinese newborn screening (NBS) programs by tandem mass spectrometry (MS/MS) is the lack of comprehensive reference intervals (RIs) for disease biomarkers. To close this gap, the Chinese National Center for Clinical Laboratories (NCCL) launched a nationwide study to investigate the dynamic pattern of 35 MS/MS NBS biomarkers and establish accurate and robust RIs. Methods: Blood spot samples from 4,714,089 Chinese neonates were tested in participating centers/laboratories and used for study analysis. MS/MS NBS biomarker trends were visually assessed by their concentrations over age. Specific partitions were determined arbitrarily by each day and sex or by the statistical method of Harris and Boyd. RIs, corresponding to the 2.5th and 97.5th percentiles, as well as the 1th, 25th, 75th and 99th percentiles were calculated for each reference partition using a non-parametric rank approach. Results: Most MS/MS NBS biomarkers fluctuated during the first week of life, followed by a relatively stable concentration. Age and sex-specific RIs were established and presented an improved specificity over the RIs used in participating centers/laboratories. Females demonstrated higher 2.5th and 97.5th percentiles in all amino acids except arginine and ornithine than males, whereas males showed higher 2.5th and 97.5th percentiles in most acylcarnitines. Conclusion: The present study determined the dynamic trends of 35 MS/MS biomarkers and established age and sex-specific RIs, valuably contributing to the current literature and timely evaluation of neonatal health and disease.
    Type of Medium: Online Resource
    ISSN: 2296-889X
    URL: Article
    URL: Article
    DOI: 10.3389/fmolb.2021.719866
    DOI: 10.3389/fmolb.2021.719866.s001
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2021
    detail.hit.zdb_id: 2814330-9
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  • 4
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    Highly sensitive tandem mass spectrometric measurement of serum estradiol without derivatization and pediatric reference intervals in children and adolescents
    Walter de Gruyter GmbH ; 2023
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 61, No. 10 ( 2023-09-26), p. 1820-1828
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 61, No. 10 ( 2023-09-26), p. 1820-1828
    Abstract: Monitoring estradiol (E2) is important for determining the onset of pubertal development as well as in the evaluation of girls with precocious puberty. However, E2 measurement remains an analytical challenge in children, who have lower circulating levels. We developed and evaluated a simple and sensitive LC-MS/MS procedure for serum E2 quantification in pediatric populations and established age- and sex-specific pediatric reference intervals. Methods Residual patient serum samples were used to evaluate the analytical performance of our in-house LC-MS/MS E2 assay. The evaluation included accuracy, precision, linearity, functional sensitivity (LLoQ), and method comparison. Age- and sex-specific pediatric E2 reference intervals were also established from a cohort of 405 healthy children (birth to 18 years) recruited with informed consent. Age- and sex-specific differences were assessed, and outliers were removed. Reference intervals were established using the robust method. Results The assay imprecision was  〈 5.3 %. Assay linearity ranged from 13.7 to 1923.3 pmol/L. The LLoQ corresponding to a CV of 20 % was determined to be 8.9 pmol/L. Bland-Altman analysis revealed a mean bias of 29.3 pmol/L or 9.1 % between our LC-MS/MS E2 assay and an external reference laboratory measuring E2 by LC-MS/MS. Conclusions Our LC-MS/MS E2 assay shows acceptable accuracy, precision, functional sensitivity (LLoQ), and linearity for E2 quantification. Our LC-MS/MS E2 assay also showed good agreement with an external reference laboratory measuring E2 by LC-MS/MS. In addition, using CALIPER samples, we established robust age- and sex-specific pediatric E2 reference intervals to improve accuracy of test result interpretation and clinical decision making.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2022-1231
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2023
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
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  • 5
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    Complex biological patterns of hematology parameters in childhood necessitating age‐ and sex‐specific reference intervals for evidence‐based clinical interpretation
    Wiley ; 2020
    In:  International Journal of Laboratory Hematology Vol. 42, No. 6 ( 2020-12), p. 750-760
    Details
    In: International Journal of Laboratory Hematology, Wiley, Vol. 42, No. 6 ( 2020-12), p. 750-760
    Abstract: Hematology laboratory parameters are among the most routinely ordered tests in support of adult and pediatric care. However, appropriate interpretation of test results has been a challenge in pediatrics since accurate and up‐to‐date reference intervals that reflect the dynamic physiological changes associated with growth and development have not been available. Critical gaps continue to exist in pediatric hematology reference intervals for modern laboratory platforms. To address this gap, this study establishes age‐ and sex‐specific reference intervals for 25 hematology parameters in the CALIPER cohort of healthy children and adolescents using a common platform, the Sysmex XN‐3000 analytical system. Methods Fresh whole blood samples collected from a total of 641 healthy children and adolescents (birth to 〈 21 years) with informed consent were analyzed for 25 hematological parameters on the Sysmex XN‐3000 Hematology Analyzer. Age‐ and sex‐specific reference standards were calculated based on Clinical and Laboratory Standards Institute guidelines. Results Of the 25 analytes assessed, 19 required age‐partitioning and seven required sex‐partitioning (ie, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, red blood cell distribution width—SD, red blood cell distribution width—CV, and monocyte percentage). Age‐ and sex‐specific differences mostly coincided with the onset of puberty. Conclusion This study establishes a comprehensive database of pediatric reference intervals for hematology parameters in the CALIPER cohort using the widely used Sysmex XN‐3000 analytical platform. These data highlight the dynamic hematological profile observed in healthy children and adolescents and the need for reference interval stratification by age and sex.
    Type of Medium: Online Resource
    ISSN: 1751-5521 , 1751-553X
    URL: Issue
    URL: Article
    DOI: 10.1111/ijlh.v42.6
    DOI: 10.1111/ijlh.13306
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2268600-9
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  • 6
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    Comprehensive pediatric reference intervals for 79 hematology markers in the CALIPER cohort of healthy children and adolescents using the Mindray BC‐6800Plus system
    Wiley ; 2023
    In:  International Journal of Laboratory Hematology Vol. 45, No. 4 ( 2023-08), p. 469-480
    Details
    In: International Journal of Laboratory Hematology, Wiley, Vol. 45, No. 4 ( 2023-08), p. 469-480
    Abstract: Hematological parameters vary significantly throughout growth and development due to physiological processes such as fetal‐to‐adult erythropoiesis and puberty. Pediatric age‐ and sex‐specific reference intervals (RIs) are thus essential for appropriate clinical decision‐making. The current study aimed to establish RIs for both common and novel hematology parameters on the Mindray BC‐6800Plus system. Methods Six hundred and eighty‐seven healthy children and adolescents (30 days to 18 years) were enrolled. Participants were recruited as part of the Canadian Laboratory Initiative on Pediatric Reference Intervals Program upon informed consent or identified from apparently healthy outpatient clinics. Whole blood was collected and assayed for 79 hematology parameters on the BC‐6800Plus system (Mindray). Age‐ and sex‐specific RIs were established as per Clinical and Laboratory Standards Institute EP28‐A3c guidelines. Results Dynamic reference value distributions were observed for several hematology parameters, including erythrocytes, leukocytes, platelets, reticulocytes, and research‐use‐only markers. Age partitioning was required for 52 parameters, demonstrating changes in infancy and puberty. Sex partitioning was required for 11 erythrocyte parameters (i.e., red blood cell (RBC), hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin concentration, RBC distribution width coefficient of variation, hemoglobin distribution width, macrocyte count, macrocyte percentage, RBC (optical), and reticulocyte production index). Few parameters had undetectable levels in our healthy cohort (i.e., nucleated RBC count and immature granulocyte count). Conclusions The current study completed hematological profiling for 79 parameters on the BC‐6800Plus system in a healthy cohort of Canadian children and adolescents. These data emphasize the complex biological patterns of hematology parameters in childhood, particularly at the onset of puberty, and support the need for age‐ and sex‐specific RIs for clinical interpretation.
    Type of Medium: Online Resource
    ISSN: 1751-5521 , 1751-553X
    URL: Issue
    URL: Article
    DOI: 10.1111/ijlh.v45.4
    DOI: 10.1111/ijlh.14068
    Language: English
    Publisher: Wiley
    Publication Date: 2023
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  • 7
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    Pediatric Reference Value Profiling of Essential Trace and Toxic Elements in Healthy Children and Adolescents Using High-Resolution and Triple Quadrupole Inductively Coupled Plasma Mass Spectrometry
    Oxford University Press (OUP) ; 2023
    In:  The Journal of Applied Laboratory Medicine Vol. 8, No. 4 ( 2023-07-05), p. 674-688
    Details
    In: The Journal of Applied Laboratory Medicine, Oxford University Press (OUP), Vol. 8, No. 4 ( 2023-07-05), p. 674-688
    Abstract: Assessment of trace and toxic element status is important for the diagnosis and monitoring of several pediatric conditions. Elemental deficiency and toxicity have serious implications, particularly in pediatrics wherein risk is higher. Pediatric reference intervals (RIs) for trace elements and normal exposure limits for toxic elements are lacking on modern analytical systems. Herein, reference values were established for 13 plasma and 22 whole blood trace elements in the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort of healthy children and adolescents. Methods Approximately 320 healthy children and adolescents were recruited with informed consent. Trace elements were measured in whole blood and plasma samples using 2 technologies: (a) triple quadrupole inductively coupled plasma tandem mass spectrometry (ICP-MS/MS) (n = 172) and (b) high-resolution sector field ICPMS (HR-SF-ICPMS) (n =161). RIs and normal exposure limits were then established according to Clinical and Laboratory Standards Institute guidelines. Results Of all elements assessed, none required sex partitioning and 8 required age partitioning (e.g., copper, manganese, and cadmium). Reference value distributions determined via ICP-MS/MS and HR-SF-ICPMS demonstrated excellent concordance, with few exceptions (e.g., molybdenum, cobalt, and nickel). Conclusions These data represent the first study wherein pediatric RIs and normal exposure limits were derived simultaneously on 2 different clinically validated MS platforms which provide urgently needed data to inform clinical decision-making for trace elements in pediatrics. Study findings suggest some trace elements require age-specific consideration for appropriate interpretation. Highly concordant observations across the 2 analytical methods also demonstrate the comparability and reliability of results obtained on both platforms.
    Type of Medium: Online Resource
    ISSN: 2475-7241
    URL: Article
    DOI: 10.1093/jalm/jfad019
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 8
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    Pediatric Reference Intervals for Point-of-Care Random Glucose in Healthy Children and Adolescents
    Oxford University Press (OUP) ; 2022
    In:  The Journal of Applied Laboratory Medicine Vol. 7, No. 2 ( 2022-03-02), p. 582-588
    Details
    In: The Journal of Applied Laboratory Medicine, Oxford University Press (OUP), Vol. 7, No. 2 ( 2022-03-02), p. 582-588
    Abstract: Glucose testing at the point-of-care (POC) is routinely used in the diagnosis, prognosis, and monitoring of diabetic states and other clinical conditions. Accurate reference intervals (RIs) are essential in appropriate clinical decision-making. In this study, RIs were established for random glucose (whole blood) in the Canadian Laboratory Initiative on Pediatric Reference (CALIPER) cohort using 2 POC instruments: the Nova Biomedical StatStrip (handheld glucometer) and Radiometer ABL90 FLEX Plus (benchtop instrument). An analytical comparison was also completed between the 2 POC systems and a laboratory-based analyzer (Ortho Vitros 5600). Methods Approximately 400 healthy children and adolescents (birth to 18 years) were recruited with informed consent from community schools or clinics providing care to metabolically stable/healthy children. Random venous samples were collected and run sequentially on the Nova Biomedical StatStrip (whole blood), Radiometer ABL90 FLEX Plus (whole blood), and Ortho Vitros 5600 (serum). RIs and method comparisons between analytical platforms were completed according to CLSI guidelines. Results Significantly different glucose concentrations were observed in infancy, requiring age-specific partitioning (0– & lt;1 month, 1– & lt;6 months, 6 months– & lt;19 years) on all platforms. Excellent concordance was observed between POC platforms (Pearson r  & gt; 0.90), with a small negative bias. Good comparability was observed between POC and laboratory-based platforms (Pearson r  & gt; 0.80). Conclusion This study established comprehensive pediatric RIs for random glucose (whole blood) on modern POC systems in the CALIPER cohort for the first time. Results demonstrate excellent concordance in glucose values between POC systems and good comparability with a laboratory-based analyzer. These data will assist in more accurate clinical decision-making in pediatric healthcare institutions.
    Type of Medium: Online Resource
    ISSN: 2576-9456 , 2475-7241
    URL: Article
    DOI: 10.1093/jalm/jfab155
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 9
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    Comprehensive Pediatric Reference Limits for High-Sensitivity Cardiac Troponin I and NT-proBNP in the CALIPER Cohort
    Oxford University Press (OUP) ; 2023
    In:  The Journal of Applied Laboratory Medicine Vol. 8, No. 3 ( 2023-05-04), p. 443-456
    Details
    In: The Journal of Applied Laboratory Medicine, Oxford University Press (OUP), Vol. 8, No. 3 ( 2023-05-04), p. 443-456
    Abstract: Cardiac biomarkers have increasing application in pediatric populations, including congenital heart disease, myocarditis, and heart failure. Clinical practice is limited by evidence gaps in pediatric reference limits to inform clinical decision-making. The current study aimed to establish comprehensive pediatric reference limits for N-terminal (NT)-pro hormone brain natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I (hs-cTnI) in the CALIPER cohort of healthy children and adolescents. Methods Analytical immunoassay performance was assessed through precision, linearity, and method comparison (Abbott Alinity ci system). Subsequently, approximately 200 serum samples collected from apparently healthy children (birth to 18 years) were analyzed for hs-cTnI and NT-proBNP. Reference limits (2.5th, 97.5th, and 99th percentiles) were established as per Clinical and Laboratory Standards Institute EP-28A3c guidelines with associated 90% confidence intervals. Results Of all pediatric serum samples analyzed, 46% had detectable hs-cTnI concentrations (limit of detection: 1.3 ng/L). Both hs-cTnI and NT-proBNP demonstrated markedly elevated neonatal concentrations with 99th percentiles of 55.8 and 1785 ng/L, respectively. No statistically significant age-specific differences were observed beyond 1 year of age across all cardiac biomarkers examined. No sex-specific association was observed between hs-cTnI and NT-proBNP concentration and adolescence. Conclusions We report age-specific reference limits for hs-cTnI and NT-proBNP in a healthy Canadian cohort of children and adolescents measured using Alinity immunoassays for the first time. These data support the need for pediatric-specific interpretation to reduce misinformed clinical decision-making and calls to action larger cohort studies such that reference limits can be more robustly defined.
    Type of Medium: Online Resource
    ISSN: 2475-7241
    URL: Article
    DOI: 10.1093/jalm/jfad012
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 10
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    Anti-mullerian hormone (AMH) in the caliper cohort of healthy community children and adolescents: improving care in oncofertility
    Elsevier BV ; 2019
    In:  Fertility and Sterility Vol. 112, No. 3 ( 2019-09), p. e436-
    Details
    In: Fertility and Sterility, Elsevier BV, Vol. 112, No. 3 ( 2019-09), p. e436-
    Type of Medium: Online Resource
    ISSN: 0015-0282
    URL: Article
    DOI: 10.1016/j.fertnstert.2019.08.016
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
    detail.hit.zdb_id: 1500469-7
    SSG: 12
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