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Article: Comprehensive Pediatric Reference Limits for High-Sensitivity Cardiac Troponin I and NT-proBNP in the CALIPER Cohort.

Bohn, Mary Kathryn / Adeli, Khosrow

The journal of applied laboratory medicine

2023 Volume 8, Issue 3, Page(s) 443–456

Abstract: Background: 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 ... ...

Abstract	Background: 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.
MeSH term(s)	Infant, Newborn ; Humans ; Child ; Adolescent ; Natriuretic Peptide, Brain ; Troponin I ; Biomarkers ; Canada
Chemical Substances	pro-brain natriuretic peptide (1-76) ; Natriuretic Peptide, Brain (114471-18-0) ; Troponin I ; Biomarkers
Language	English
Publishing date	2023-04-06
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2576-9456
ISSN	2576-9456
DOI	10.1093/jalm/jfad012
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Article ; Online: SARS-CoV-2 serology in pediatrics: Seroprevalence studies in unvaccinated children and humoral antibody response post vaccination.

Bohn, Mary Kathryn / Steele, Shannon / Adeli, Khosrow

Clinical biochemistry

2023 Volume 119, Page(s) 110630

Abstract: Background: Humoral response against SARS-CoV-2 is increasingly accepted as the central correlate of immune protection. Recent pediatric seroprevalence data are extremely limited. Significant knowledge gaps also exist in immune response to mRNA SARS-CoV- ...

Abstract	Background: Humoral response against SARS-CoV-2 is increasingly accepted as the central correlate of immune protection. Recent pediatric seroprevalence data are extremely limited. Significant knowledge gaps also exist in immune response to mRNA SARS-CoV-2 vaccination in children. As children demonstrate distinct response to naïve infection relative to adults, it is essential to investigate age-specific differences in seroprevalence and antibody response to SARS-CoV-2 vaccination. Methods: Seroprevalence was assessed through two cross-sectional serosurveys prior to COVID-19 vaccination approval in children <5 years using residual patient specimens (n = 2902). To assess antibody response post-vaccination, 842 participants (580 children, 262 adults) were prospectively recruited with informed consent. Participation required completion of a health questionnaire and blood donation. Samples were collected at varying times post-vaccination and assayed using the Abbott AdviseDx SARS-CoV-2 IgG II and DiaSorin LIAISON SARS-CoV-2 TrimericS IgG assays. Results: Significant increases in seroprevalence were observed between the first and second serosurveys in unvaccinated children <6 months to 5 years (38-75%). In the prospective vaccination cohort, serokinetic response decreased with time post-dose of an mRNA vaccine. Measured IgG titres were significantly higher in children relative to adults across all time points. Conclusions: This is the largest evaluation of quantitative SARS-CoV-2 antibody assays in a cohort of Canadian children, adolescents, and adults. Findings suggest high rates of SARS-CoV-2 exposure among unvaccinated young children in the Toronto community. Additional data supports children have higher antibody titres relative to adults post-vaccination.
MeSH term(s)	Adolescent ; Adult ; Humans ; Child ; Child, Preschool ; Antibody Formation ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines ; Canada ; Cross-Sectional Studies ; Prospective Studies ; SARS-CoV-2 ; Seroepidemiologic Studies ; Antibodies, Viral ; Immunoglobulin G ; Vaccination
Chemical Substances	COVID-19 Vaccines ; Antibodies, Viral ; Immunoglobulin G
Language	English
Publishing date	2023-08-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	390372-2
ISSN	1873-2933 ; 0009-9120
ISSN (online)	1873-2933
ISSN	0009-9120
DOI	10.1016/j.clinbiochem.2023.110630
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Article ; Online: Physiological and metabolic adaptations in pregnancy: importance of trimester-specific reference intervals to investigate maternal health and complications.

Bohn, Mary Kathryn / Adeli, Khosrow

Critical reviews in clinical laboratory sciences

2021 Volume 59, Issue 2, Page(s) 76–92

Abstract: Diagnosis, prognostication, and monitoring of maternal health throughout pregnancy relies on laboratory testing, including but not limited to key markers of thyroid, hepatic, cardiac, hematology, and renal function. Dynamic physiological processes during ...

Abstract	Diagnosis, prognostication, and monitoring of maternal health throughout pregnancy relies on laboratory testing, including but not limited to key markers of thyroid, hepatic, cardiac, hematology, and renal function. Dynamic physiological processes during gestation significantly influence the maternal biochemistry that supports both the mother and fetus. Resultant changes in blood biochemistry alter the expected values of common laboratory tests. However, the importance of pregnancy-specific reference intervals for laboratory test result interpretation and appropriate monitoring of maternal health and complications is underappreciated. Most clinical laboratories continue to use non-pregnant adult reference intervals for laboratory test interpretation in pregnancy. The current review summarizes and critically evaluates the available literature regarding physiological and metabolic adaptations in pregnancy and their influence on common biomarkers of health and disease. The main laboratory parameters discussed include thyroid, hepatic, metabolic, renal, hematology, inflammatory, and cardiac markers. Considering the available data, further studies are urgently needed to establish trimester-specific reference intervals in healthy pregnant women on updated analytical platforms. Without such data, the standard of clinical laboratory service in pregnancy remains compromised and affects the quality of maternal-fetal healthcare.
MeSH term(s)	Adult ; Biomarkers ; Female ; Humans ; Maternal Health ; Pregnancy ; Reference Values ; Thyroid Gland/physiology
Chemical Substances	Biomarkers
Language	English
Publishing date	2021-09-29
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	280641-1
ISSN	1549-781X ; 1040-8363 ; 0590-8191
ISSN (online)	1549-781X
ISSN	1040-8363 ; 0590-8191
DOI	10.1080/10408363.2021.1978923
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Article ; Online: Pediatric reference interval verification for 16 biochemical markers on the Alinity ci system in the CALIPER cohort of healthy children and adolescents.

Bohn, Mary Kathryn / Schneider, Randal / Jung, Benjamin / Adeli, Khosrow

Clinical chemistry and laboratory medicine

2023 Volume 61, Issue 11, Page(s) 2033–2040

Abstract: Objectives: Special chemistry parameters are useful in the diagnosis and management of inherited disorders, liver disease, and immunopathology. Evidence-based pediatric reference intervals (RIs) are required for appropriate clinical decision-making and ... ...

Abstract	Objectives: Special chemistry parameters are useful in the diagnosis and management of inherited disorders, liver disease, and immunopathology. Evidence-based pediatric reference intervals (RIs) are required for appropriate clinical decision-making and need to be verified as new assays are developed. This study aimed to evaluate the applicability of pediatric RIs established for biochemical markers on the ARCHITECT for use on newer Alinity assays. Methods: An initial method validation was completed for 16 assays, including precision, linearity, and method comparison. Sera collected from approximately 100 healthy children and adolescents as part of the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) were also analyzed on the Alinity c system. Percentage of results within established ARCHITECT RIs were calculated and considered verified if ≥90 % fell within established limits. New RIs were established for three electrolytes, glucose, and lactate wherein no data were previously reported. Results: Of the 11 assays for which CALIPER pediatric RIs were previously established on ARCHITECT assays, 10 met the verification criteria. Alpha-1-antitrypsin did not meet verification criterion and a new RI was established. For the other 5 assays, Conclusions: Herein, pediatric RIs were verified or established for 16 chemistry markers in the CALIPER cohort on Alinity assays. Findings support excellent concordance between ARCHITECT and Alinity assays with one exception (alpha-1-antitrypsin) as well as robustness of age- and sex-specific patterns originally reported by CALIPER in healthy Canadian children and adolescents.
MeSH term(s)	Male ; Female ; Child ; Humans ; Adolescent ; Reference Values ; Serum ; Biomarkers ; Laboratories ; Lactic Acid
Chemical Substances	Biomarkers ; Lactic Acid (33X04XA5AT)
Language	English
Publishing date	2023-05-01
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1418007-8
ISSN	1437-4331 ; 1434-6621 ; 1437-8523
ISSN (online)	1437-4331
ISSN	1434-6621 ; 1437-8523
DOI	10.1515/cclm-2023-0256
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Article ; Online: Comprehensive pediatric reference intervals for 79 hematology markers in the CALIPER cohort of healthy children and adolescents using the Mindray BC-6800Plus system.

Bohn, Mary Kathryn / Wilson, Siobhan / Steele, Shannon / Adeli, Khosrow

International journal of laboratory hematology

2023 Volume 45, Issue 4, Page(s) 469–480

Abstract: Background: 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 ... ...

Abstract	Background: 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.
MeSH term(s)	Male ; Adult ; Female ; Child ; Humans ; Adolescent ; Erythrocyte Count ; Hematology ; Erythrocytes ; Hematocrit ; Hemoglobins ; Reference Values
Chemical Substances	Hemoglobins
Language	English
Publishing date	2023-03-29
Publishing country	England
Document type	Journal Article
ZDB-ID	2268590-X
ISSN	1751-553X ; 1751-5521 ; 0141-9854
ISSN (online)	1751-553X
ISSN	1751-5521 ; 0141-9854
DOI	10.1111/ijlh.14068
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Article: Application of the TML method to big data analytics and reference interval harmonization

Bohn, Mary Kathryn / Adeli, Khosrow

Journal of laboratory medicine

2021 Volume 45, Issue 2, Spec. Iss. Indirect Referende Limits, Page(s) 79

Language	English
Document type	Article
ZDB-ID	2909041-6
ISSN	2567-9430
Database	Current Contents Medicine

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Article ; Online: Central role of laboratory medicine in public health and patient care.

Olver, Pyper / Bohn, Mary Kathryn / Adeli, Khosrow

Clinical chemistry and laboratory medicine

2022 Volume 61, Issue 4, Page(s) 666–673

Abstract: Clinical laboratories play a vital role in the healthcare system. Objective medical data provided by clinical laboratories supports approximately 60-70% of clinical decisions, however, evidence supporting this claim is poorly documented and laboratories ... ...

Abstract	Clinical laboratories play a vital role in the healthcare system. Objective medical data provided by clinical laboratories supports approximately 60-70% of clinical decisions, however, evidence supporting this claim is poorly documented and laboratories still lack visibility, despite their indisputable impact on patient care and public health. The International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Outcome Studies in Laboratory Medicine (TF-OSLM) was recently developed to support directed research evaluating the role of laboratory medicine on clinical outcomes. Establishing and documenting this evidence is key to enhance visibility of the field in the eye of the public and other healthcare professionals together with optimizing patient outcomes and health care system operations. In this review, we discuss four areas that exemplify the contribution of laboratory medicine directly to patient care. This includes high-sensitivity cardiac troponin (hs-cTn) and N-terminal pro-B-type natriuretic peptide/B-type natriuretic peptides (NT-proBNP/BNP) for the diagnosis and prognosis of myocardial infarction and heart failure, respectively, and procalcitonin for the management of sepsis and antibiotic stewardship. Emerging markers of traumatic brain injury and the role of laboratory medicine in the fight against the COVID-19 pandemic are discussed along with an introduction to plans of IFCC TF-OSLM.
MeSH term(s)	Humans ; Laboratories ; Public Health ; Pandemics ; COVID-19 ; Prognosis ; Natriuretic Peptide, Brain ; Patient Care ; Peptide Fragments ; Biomarkers
Chemical Substances	Natriuretic Peptide, Brain (114471-18-0) ; Peptide Fragments ; Biomarkers
Language	English
Publishing date	2022-11-28
Publishing country	Germany
Document type	Review ; Journal Article
ZDB-ID	1418007-8
ISSN	1437-4331 ; 1434-6621 ; 1437-8523
ISSN (online)	1437-4331
ISSN	1434-6621 ; 1437-8523
DOI	10.1515/cclm-2022-1075
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Article ; Online: LMS-based continuous reference percentiles for 14 laboratory parameters in the CALIPER cohort of healthy children and adolescents.

Wilson, Siobhan M / Bohn, Mary Kathryn / Madsen, Andre / Hundhausen, Thomas / Adeli, Khosrow

Clinical chemistry and laboratory medicine

2023 Volume 61, Issue 6, Page(s) 1105–1115

Abstract: Objectives: Marked physiological changes in growth and development present challenges in defining pediatric reference intervals for biomarkers of health and disease. Lambda, Mu, and Sigma (LMS)-based statistical modeling provides a continuous normal ... ...

Abstract	Objectives: Marked physiological changes in growth and development present challenges in defining pediatric reference intervals for biomarkers of health and disease. Lambda, Mu, and Sigma (LMS)-based statistical modeling provides a continuous normal distribution by negating skewness and variation, and is commonly used to establish growth charts. Such LMS reference curves are suggested to enhance laboratory test result interpretation. The current study establishes LMS-based continuous reference percentiles for 14 biomarkers in the CALIPER cohort of healthy children and adolescents. Methods: Data from healthy children and adolescents aged 1-<19 years were used to establish continuous reference percentiles using a novel LMS-based statistical method, including 2.5th, 25th, 50th, 75th, and 97.5th percentiles. The LMS approach applies a Box-Cox data transformation and summarizes continuous distributions by age via three curves: skewness (Lambda), median (Mu), and coefficient of variation (Sigma). Results: LMS-based percentiles and z-scores were generated for 14 common pediatric biomarkers that demonstrate dynamic concentration patterns with age (e.g., alkaline phosphatase) and/or wherein the magnitude of difference from the population mean may be clinically relevant (e.g., triglycerides). The LMS model captured age- and sex-specific distributions accurately and was not substantially influenced by outlying points. Conclusions: This is the first study to establish LMS-based continuous reference percentiles for biochemical markers in a healthy Canadian pediatric population. The current LMS-based approach builds upon previous continuous reference interval models by providing graded percentiles to improve test result interpretation, particularly with repeated measures over time. This method may assist in facilitating a patient-centered approach to laboratory medicine.
MeSH term(s)	Adolescent ; Child ; Female ; Humans ; Male ; Biomarkers ; Canada ; Models, Statistical ; Reference Values ; Infant ; Child, Preschool ; Young Adult
Chemical Substances	Biomarkers
Language	English
Publishing date	2023-01-16
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1418007-8
ISSN	1437-4331 ; 1434-6621 ; 1437-8523
ISSN (online)	1437-4331
ISSN	1434-6621 ; 1437-8523
DOI	10.1515/cclm-2022-1077
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Article: 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.

Bohn, Mary Kathryn / Nichols, Matthew / Yang, Liju / Bhayana, Vipin / Macri, Joseph / Adeli, Khosrow

The journal of applied laboratory medicine

2023 Volume 8, Issue 4, Page(s) 674–688

Abstract: Background: 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. ... ...

Abstract	Background: 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.
MeSH term(s)	Humans ; Child ; Adolescent ; Trace Elements/analysis ; Reference Values ; Tandem Mass Spectrometry ; Reproducibility of Results ; Clinical Laboratory Services
Chemical Substances	Trace Elements
Language	English
Publishing date	2023-05-18
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2576-9456
ISSN	2576-9456
DOI	10.1093/jalm/jfad019
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Article ; Online: POCT: An Inherently Ideal Tool in Pediatric Laboratory Medicine.

Wilson, Siobhan / Bohn, Mary Kathryn / Adeli, Khosrow

EJIFCC

2021 Volume 32, Issue 2, Page(s) 145–157

Abstract: Point of care testing (POCT) is important in the provision of timely laboratory test results and continues to gain specific appreciation in the setting of pediatric healthcare. POCT platforms offer several advantages compared to central laboratory ... ...

Abstract	Point of care testing (POCT) is important in the provision of timely laboratory test results and continues to gain specific appreciation in the setting of pediatric healthcare. POCT platforms offer several advantages compared to central laboratory testing, including improved clinical outcomes, reduced time to diagnosis, length of stay, and blood volume requirements, as well as increased accessibility. These advantages are most pronounced in acute care settings such as pediatric emergency departments, intensive care units, and in remote settings, wherein rapid patient assessment and prognostication is essential to patient outcomes. The current review provides an overview and critical discussion of the evidence supporting clinical implementation of POCT systems in pediatric clinical decision-making, including but not limited to the diagnosis of viral and bacterial infection, identification of critical glucose and electrolyte dysregulation, and prognostication of post-operative inpatients. Important considerations for test result reporting and interpretation are also discussed, including analytical concordance between POCT systems and central laboratory analyzers as well as availability of pediatric reference intervals for key analytes on POCT systems. Notably, a paucity of evidence-based pediatric reference intervals for test interpretation for critical care parameters on POCT platforms is highlighted, warranting further study and unique consideration prior to clinical implementation.
Language	English
Publishing date	2021-06-29
Publishing country	Italy
Document type	Journal Article ; Review
ISSN	1650-3414
ISSN (online)	1650-3414
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