The Canadian laboratory initiative on pediatric reference intervals: A CALIPER white paper

被引:233
作者
Adeli, Khosrow [1 ,2 ]
Higgins, Victoria [1 ,2 ]
Trajcevski, Karin [1 ]
White-Al Habeebb, Nicole [2 ]
机构
[1] Hosp Sick Children, CALIPER Program, Pediat Lab Med, Toronto, ON, Canada
[2] Univ Toronto, Dept Lab Med & Pathobiol, Fac Med, Toronto, ON, Canada
基金
加拿大健康研究院;
关键词
CALIPER; pediatric; reference intervals; REFERENCE VALUE DISTRIBUTIONS; HEALTHY COMMUNITY CHILDREN; STRATIFIED REFERENCE INTERVALS; GERIATRIC AGES ESTABLISHMENT; ADULT REFERENCE INTERVALS; CLSI-BASED TRANSFERENCE; SPECIAL CHEMISTRY BIOMARKERS; CLINICAL DECISION LIMITS; 38 BIOCHEMICAL MARKERS; REFERENCE VALUES;
D O I
10.1080/10408363.2017.1379945
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Laboratory investigations provide physicians with objective data to aid in disease diagnosis, clinical decision making, and patient follow up. Clinical interpretation of laboratory test results relies heavily on the availability of appropriate population-based reference intervals (i.e. normative values) or decision limits developed through clinical outcome studies. Although reference intervals are fundamental to accurate laboratory test interpretation, and thus critically important to healthcare, the need for sound evidence-based reference intervals has been largely overlooked, particularly in the pediatric population. In the field of pediatric laboratory medicine, accurate age-and sex-specific reference intervals established using samples from healthy children and adolescents have not been readily available, forcing many clinical laboratories to report adult reference intervals with pediatric test results. When pediatric reference intervals are available, they have often been established with a small sample size, inpatient or outpatient samples, outdated methodologies, and/or inappropriate statistical procedures. To address these unacceptable limitations, several national and global initiatives have begun to close the critical evidence gaps in pediatric reference intervals. Notably, the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has made significant strides towards improving pediatric healthcare in Canada and globally. The present report is a white paper summarizing CALIPER, and provides a comprehensive compendium of the data generated through this project over the past decade as a single resource for clinical laboratory specialists, clinicians, and other healthcare workers. CALIPER launched an outreach campaign in 2008 to recruit healthy community children and adolescents, and developed a robust statistical algorithm, in accordance with the Clinical and Laboratory Standards Institute (CLSI) guidelines, to develop accurate age-and sex-specific pediatric reference intervals. The first CALIPER direct reference interval study was published in 2012, with age-and sex-specific reference intervals reported for 40 common biochemical markers. To date, CALIPER has collected health information and blood samples from over 9700 community children and adolescents, and has established a comprehensive database of age-and sex-specific reference intervals for over 100 biomarkers of pediatric disease. CALIPER has also performed a series of transference and verification studies to expand the applicability of the CALIPER database to five major analytical platforms, including Abbott, Beckman, Ortho, Roche, and Siemens. Through novel knowledge translation initiatives, the CALIPER Reference Interval Database has been made freely available online (www.caliperproject.ca) as well as on a mobile application (CALIPER Reference App), and it is used by clinical laboratories across Canada, the United States, and globally. In addition to establishing this comprehensive pediatric reference interval database, CALIPER has also performed a series of sub-studies, including examining how reference intervals are affected by pre-analytical factors (i.e. sample stability at specific storage conditions, fasting status and time of sample collection), biological variation (i.e. intraindividual and interindividual biological variation, reference change values), and ethnicity and pubertal development stage. In this white paper, extensive tables of pediatric reference intervals are provided for easy reference for clinical laboratories worldwide. All data reported have been published in over 20 peer reviewed publications and are also available through the CALIPER Reference Interval Database as well as the CALIPER Reference App for mobile devices.
引用
收藏
页码:358 / 413
页数:56
相关论文
共 54 条
[1]   CLSI-based transference of CALIPER pediatric reference intervals to Beckman Coulter AU biochemical assays [J].
Abou El Hassan, Mohamed ;
Stoianov, Alexandra ;
Araujo, Petra A. T. ;
Sadeghieh, Tara ;
Chan, Man Khun ;
Chen, Yunqi ;
Randell, Edward ;
Nieuwesteeg, Michelle ;
Adeli, Khosrow .
CLINICAL BIOCHEMISTRY, 2015, 48 (16-17) :1151-1159
[2]   Complex Reference Values for Endocrine and Special Chemistry Biomarkers across Pediatric, Adult, and Geriatric Ages: Establishment of Robust Pediatric and Adult Reference Intervals on the Basis of the Canadian Health Measures Survey [J].
Adeli, Khosrow ;
Higgins, Victoria ;
Nieuwesteeg, Michelle ;
Raizman, Joshua E. ;
Chen, Yunqi ;
Wong, Suzy L. ;
Blais, David .
CLINICAL CHEMISTRY, 2015, 61 (08) :1063-1074
[3]   Biochemical Marker Reference Values across Pediatric, Adult, and Geriatric Ages: Establishment of Robust Pediatric and Adult Reference Intervals on the Basis of the Canadian Health Measures Survey [J].
Adeli, Khosrow ;
Higgins, Victoria ;
Nieuwesteeg, Michelle ;
Raizman, Joshua E. ;
Chen, Yunqi ;
Wong, Suzy L. ;
Blais, David .
CLINICAL CHEMISTRY, 2015, 61 (08) :1049-1062
[4]   Complex Biological Profile of Hematologic Markers across Pediatric, Adult, and Geriatric Ages: Establishment of Robust Pediatric and Adult Reference Intervals on the Basis of the Canadian Health Measures Survey [J].
Adeli, Khosrow ;
Raizman, Joshua E. ;
Chen, Yunqi ;
Higgins, Victoria ;
Nieuwesteeg, Michelle ;
Abdelhaleem, Mohamed ;
Wong, Suzy L. ;
Blais, David .
CLINICAL CHEMISTRY, 2015, 61 (08) :1075-1086
[5]  
[Anonymous], ETHN OR 2006 COUNTS
[6]  
[Anonymous], 2008, DEFINING ESTABLISHIN
[7]   CLSI-based transference of the CALIPER database of pediatric reference intervals to Beckman Coulter DxC biochemical assays [J].
Araujo, Petra A. T. ;
Thomas, Dylan ;
Sadeghieh, Tara ;
Bevilacqua, Victoria ;
Chan, Man Khun ;
Chen, Yunqi ;
Randell, Edward ;
Adeli, Khosrow .
CLINICAL BIOCHEMISTRY, 2015, 48 (13-14) :870-880
[8]   Pediatric Within-Day Biological Variation and Quality Specifications for 38 Biochemical Markers in the CALIPER Cohort [J].
Bailey, Dana ;
Bevilacqua, Victoria ;
Colantonio, David A. ;
Pasic, Maria D. ;
Perumal, Nandita ;
Chan, Man Khun ;
Adeli, Khosrow .
CLINICAL CHEMISTRY, 2014, 60 (03) :518-529
[9]   Marked Biological Variance in Endocrine and Biochemical Markers in Childhood: Establishment of Pediatric Reference Intervals Using Healthy Community Children from the CALIPER Cohort [J].
Bailey, Dana ;
Colantonio, David ;
Kyriakopoulou, Lianna ;
Cohen, Ashley H. ;
Chan, Man Khun ;
Armbruster, David ;
Adeli, Khosrow .
CLINICAL CHEMISTRY, 2013, 59 (09) :1393-1405
[10]   Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women [J].
Bansal, Sandeep ;
Buring, Julie E. ;
Rifai, Nader ;
Mora, Samia ;
Sacks, Frank M. ;
Ridker, Paul M. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2007, 298 (03) :309-316