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  • 1
    Online Resource
    Online Resource
    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
    detail.hit.zdb_id: 2268600-9
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  • 2
    Online Resource
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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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  • 3
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    Pediatric evaluation of clinical specificity and sensitivity of SARS-CoV-2 IgG and IgM serology assays
    Walter de Gruyter GmbH ; 2021
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 59, No. 6 ( 2021-05-26), p. e235-e237
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 59, No. 6 ( 2021-05-26), p. e235-e237
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2020-1822
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2021
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
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  • 4
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    Pediatric reference interval verification for common biochemical assays on the Abbott Alinity system
    Walter de Gruyter GmbH ; 2021
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 59, No. 9 ( 2021-08-26), p. 1554-1562
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 59, No. 9 ( 2021-08-26), p. 1554-1562
    Abstract: The quality of clinical laboratory service depends on quality laboratory operations and accurate test result interpretation based on reference intervals (RIs). As new analytical systems continue to be developed and improved, previously established RIs must be verified. The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has established comprehensive RIs for many biomarkers on several analytical systems. Here, published CALIPER RIs for 28 chemistry assays on the Abbott ARCHITECT were assessed for verification on the newer Alinity system. Methods An analytical validation was first completed to assess assay performance. CALIPER serum samples (100) were analyzed for 28 chemistry assays on the Alinity system. The percentage of results falling within published pediatric ARCHITECT reference and confidence limits was determined for each analyte. Based on Clinical and Laboratory Standards Institute (CLSI) guidelines, if ≥90% of test results fell within confidence limits of ARCHITECT assay RIs, they were considered verified. Results Of the 28 assays assessed, 26 met the criteria for verification. Reference values for calcium and magnesium did not meet the criteria for verification with 87% and 35% falling within previously established ARCHITECT confidence limits, respectively. However, both assays could be verified using pediatric RIs provided in the Abbott Alinity package insert. Conclusions In this study, CALIPER ARCHITECT RIs were verified on the Alinity system for several chemistry assays. These data demonstrate excellent concordance for most assays between the Abbott ARCHITECT and Alinity systems and will assist in the implementation of the Alinity system in pediatric healthcare institutions.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2021-0336
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2021
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
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  • 5
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    Postprandial inflammation and metabolic dysfunction in adolescents with obesity and insulin resistance
    Elsevier BV ; 2021
    In:  American Heart Journal Vol. 242 ( 2021-12), p. 171-172
    Details
    In: American Heart Journal, Elsevier BV, Vol. 242 ( 2021-12), p. 171-172
    Type of Medium: Online Resource
    ISSN: 0002-8703
    URL: Article
    DOI: 10.1016/j.ahj.2021.10.065
    RVK:
    XA 18100
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
    detail.hit.zdb_id: 2003210-9
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  • 6
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    Pediatric reference interval verification for 17 specialized immunoassays and cancer markers on the Abbott Alinity i system in the CALIPER cohort of healthy children and adolescents
    Walter de Gruyter GmbH ; 2023
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 61, No. 1 ( 2023-01-27), p. 123-132
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 61, No. 1 ( 2023-01-27), p. 123-132
    Abstract: Clinical laboratory investigation of autoimmune, metabolic, and oncologic disorders in children and adolescents relies on appropriateness of reference intervals (RIs). The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) previously established comprehensive pediatric RIs for specialized immunoassays on the Abbott ARCHITECT system. Herein, we aim to verify performance on new Alinity i assays by evaluating sera collected from healthy children as per Clinical and Laboratory Standards Institute (CLSI) EP-28A3C guidelines. Methods Precision, linearity, and method comparison experiments were completed for 17 specialized Alinity immunoassays, including cancer antigens, autoimmune peptides, and hormones. Sera collected from healthy children and adolescents (birth-18 years, n=100) were evaluated. CLSI-based verification was completed using previously established CALIPER RIs for ARCHITECT assays as the reference. Results Of 17 specialized immunoassays assays, only anti-cyclic citrullinated peptides (anti-CCP) did not meet acceptable verification criterion (i.e., ≥90% of results within ARCHITECT reference CI). Anti-thyroglobulin, anti-thyroid peroxidase, and carcinoembryonic antigen did not require age-specific consideration beyond one year of age, with 63, 91, and 80% of samples equalling the limit of detection, respectively. Estimates were separated by sex for relevant assays (e.g., sex hormone binding globulin, total and free prostate specific antigen). Conclusions Findings support transferability of pediatric RIs on ARCHITECT system to the Alinity system for 16 specialized immunoassays in the CALIPER cohort and will be a useful resource for pediatric clinical laboratories using Alinity assays. Further work is needed to establish evidence-based interpretative recommendations for anti-CCP and continue to evaluate pediatric RI acceptability for newly available assay technologies.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2022-0709
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2023
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
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  • 7
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    Continuous reference intervals for 19 endocrine, fertility, and immunochemical markers in the CALIPER cohort of healthy children and adolescents
    Elsevier BV ; 2021
    In:  Clinical Biochemistry Vol. 94 ( 2021-08), p. 35-41
    Details
    In: Clinical Biochemistry, Elsevier BV, Vol. 94 ( 2021-08), p. 35-41
    Type of Medium: Online Resource
    ISSN: 0009-9120
    URL: Article
    DOI: 10.1016/j.clinbiochem.2021.04.014
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
    detail.hit.zdb_id: 1496880-0
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  • 8
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    Pediatric reference interval verification for endocrine and fertility hormone assays on the Abbott Alinity system
    Walter de Gruyter GmbH ; 2021
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 59, No. 10 ( 2021-09-27), p. 1680-1687
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 59, No. 10 ( 2021-09-27), p. 1680-1687
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2021-0337
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2021
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
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  • 9
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    Pediatric Reference Intervals for Critical Point-of-Care Whole Blood Assays in the CALIPER Cohort of Healthy Children and Adolescents
    Oxford University Press (OUP) ; 2021
    In:  American Journal of Clinical Pathology Vol. 156, No. 6 ( 2021-11-08), p. 1030-1037
    Details
    In: American Journal of Clinical Pathology, Oxford University Press (OUP), Vol. 156, No. 6 ( 2021-11-08), p. 1030-1037
    Abstract: Point-of-care testing (POCT) is being increasingly adopted to support clinical care. Data for critical care parameters in healthy children on POCT instruments are lacking. We established comprehensive reference standards for several whole blood parameters on the Radiometer ABL90 FLEX PLUS blood gas analyzer in the Canadian Laboratory Initiative on Paediatric Reference Intervals (CALIPER) cohort. Methods Approximately 300 healthy children and adolescents (age range, birth to & lt;19 years; sex, boys and girls) were recruited with informed consent. Venous whole blood was collected (using heparinized syringes) and rapidly analyzed at the point of collection for pH, Pco2, Po2, carboxyhemoglobin, methemoglobin, lactate, and electrolytes on the ABL90 FLEX PLUS instrument. Reference intervals were established according to Clinical and Laboratory Standards Institute guidelines. Results Of the parameters assessed, 6 required age partitioning; none required sex partitioning. Reference value distributions were consistent across the pediatric age range, demonstrating higher variation in the early neonatal period. Conclusions This study established reference standards for 10 critical care analytes in the CALIPER cohort for the first time. These data contribute to our understanding of normative pediatric values for venous electrolytes, metabolites, and blood gases on a modern POCT instrument, facilitating test interpretation in clinical settings that use these assays.
    Type of Medium: Online Resource
    ISSN: 0002-9173 , 1943-7722
    URL: Article
    DOI: 10.1093/ajcp/aqab064
    RVK:
    YV 2000
    RVK:
    XA 18700
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2039921-2
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  • 10
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    Continuous reference curves for common hematology markers in the CALIPER cohort of healthy children and adolescents on the Sysmex XN‐3000 system
    Wiley ; 2021
    In:  International Journal of Laboratory Hematology Vol. 43, No. 6 ( 2021-12), p. 1394-1402
    Details
    In: International Journal of Laboratory Hematology, Wiley, Vol. 43, No. 6 ( 2021-12), p. 1394-1402
    Abstract: Clinicians and healthcare professionals rely heavily on health‐associated standards, such as reference intervals (RIs), for appropriate laboratory test result interpretation. RIs are commonly partitioned into discrete age/sex bins based on statistical and/or clinical significance. In pediatric hematology, such partitioning does not adequately represent complex variation in analyte concentrations throughout maturation. The objective of this study was to establish continuous RIs for common hematological parameters in the healthy pediatric Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort. Methods Data from healthy CALIPER children and adolescents (6 months‐ 〈 19 years) were used to generate continuous RIs (ie, 2.5th and 97.5th quantiles) for 19 hematological parameters. Continuous curves were statistically established with nonparametric quantile regressions. Flagging rate analysis was completed for the established continuous upper and lower reference limits and subsequently compared to previously published discrete CALIPER reference intervals for all parameters. Results Continuous RIs were established for 19 hematology parameters, where seven required sex‐specific reference curves. Based on flagging rate assessment, continuous RIs appear to more accurately estimate hematological reference limits over the pediatric age range, especially for analytes with complex age‐ and sex‐specific reference value patterns. Conclusions This is the first study to generate continuous RIs for a breadth of hematological markers in a healthy pediatric Canadian population. The increased power of continuous reference intervals to accurately estimate the complex relationship between hematological analyte concentration and age during a time of extensive growth and development is expected to improve laboratory test result interpretation and, subsequently, pediatric clinical decision‐making.
    Type of Medium: Online Resource
    ISSN: 1751-5521 , 1751-553X
    URL: Issue
    URL: Article
    DOI: 10.1111/ijlh.v43.6
    DOI: 10.1111/ijlh.13670
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2268600-9
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