Closing the Gaps in Pediatric Laboratory Reference Intervals: A CALIPER Database of 40 Biochemical Markers in a Healthy and Multiethnic Population of Children

2013 ◽  
Vol 2013 ◽  
pp. 321-322
Author(s):  
M.G. Bissell
2012 ◽  
Vol 58 (5) ◽  
pp. 854-868 ◽  
Author(s):  
David A Colantonio ◽  
Lianna Kyriakopoulou ◽  
Man Khun Chan ◽  
Caitlin H Daly ◽  
Davor Brinc ◽  
...  

Abstract BACKGROUND Pediatric healthcare is critically dependent on the availability of accurate and precise laboratory biomarkers of pediatric disease, and on the availability of reference intervals to allow appropriate clinical interpretation. The development and growth of children profoundly influence normal circulating concentrations of biochemical markers and thus the respective reference intervals. There are currently substantial gaps in our knowledge of the influences of age, sex, and ethnicity on reference intervals. We report a comprehensive covariate-stratified reference interval database established from a healthy, nonhospitalized, and multiethnic pediatric population. METHODS Healthy children and adolescents (n = 2188, newborn to 18 years of age) were recruited from a multiethnic population with informed parental consent and were assessed from completed questionnaires and according to defined exclusion criteria. Whole-blood samples were collected for establishing age- and sex-stratified reference intervals for 40 serum biochemical markers (serum chemistry, enzymes, lipids, proteins) on the Abbott ARCHITECT c8000 analyzer. RESULTS Reference intervals were generated according to CLSI C28-A3 statistical guidelines. Caucasians, East Asians, and South Asian participants were evaluated with respect to the influence of ethnicity, and statistically significant differences were observed for 7 specific biomarkers. CONCLUSIONS The establishment of a new comprehensive database of pediatric reference intervals is part of the Canadian Laboratory Initiative in Pediatric Reference Intervals (CALIPER). It should assist laboratorians and pediatricians in interpreting test results more accurately and thereby lead to improved diagnosis of childhood diseases and reduced patient risk. The database will also be of global benefit once reference intervals are validated in transference studies with other analytical platforms and local populations, as recommended by the CLSI.


2014 ◽  
Vol 34 (1) ◽  
pp. 23-30 ◽  
Author(s):  
Kimiya Karbasy ◽  
Petra Ariadne ◽  
Stephanie Gaglione ◽  
Michelle Nieuwesteeg ◽  
Khosrow Adeli

Summary Clinical laboratory reference intervals provide valuable information to medical practitioners in their interpretation of quantitative laboratory test results, and therefore are critical in the assessment of patient health and in clinical decisionmaking. The reference interval serves as a health-associated benchmark with which to compare an individual test result. Unfortunately, critical gaps currently exist in accurate and upto-date pediatric reference intervals for accurate interpretation of laboratory tests performed in children and adolescents. These critical gaps in the available laboratory reference intervals have the clear potential of contributing to erroneous diagnosis or misdiagnosis of many diseases. To address these important gaps, several initiatives have begun internationally by a number of bodies including the KiGGS initiative in Germany, the Aussie Normals in Australia, the AACC-National Children Study in USA, the NORICHILD Initiative in Scandinavia, and the CALIPER study in Canada. In the present article, we will review the gaps in pediatric reference intervals, challenges in establishing pediatric norms in healthy children and adolescents, and the major contributions of the CALIPER program to closing the gaps in this crucial area of pediatric laboratory medicine. We will also discuss the recently published CALIPER reference interval database (www.caliperdatabase.com) developed to provide comprehensive age and gender specific pediatric reference intervals for a larger number of biochemical markers, based on a large and diverse healthy children cohort. The CALIPER database is based on a multiethnic population examining the influence of ethnicity on laboratory reference intervals. Thus the database has proved to be of global benefit and is being adopted by hospital laboratories worldwide.


2020 ◽  
Vol 34 (11) ◽  
Author(s):  
Hamideh Ghazizadeh ◽  
Mary Kathryn Bohn ◽  
Roshanak Ghaffarian Zirak ◽  
Atieh Kamel Khodabandeh ◽  
Reza Zare‐Feyzabadi ◽  
...  

2012 ◽  
Vol 50 (5) ◽  
Author(s):  
Hallvard Lilleng ◽  
Stein Harald Johnsen ◽  
Tom Wilsgaard ◽  
Svein Ivar Bekkelund

AbstractLaboratory reference intervals are not necessarily reflecting the range in the background population. This study compared creatine kinase (CK) reference intervals calculated from a large sample from a Norwegian population with those elaborated by the Nordic Reference Interval Project (NORIP). It also assessed the pattern of CK-normalization after standardized control analyses.New upper reference limits (URL) CK values were calculated after exclusion of individuals with risk of hyperCKemia and including individuals with incidentally detected hyperCKemia after they had completed a standardized control analysis. After exclusion of 5924 individuals with possible causes of hyperCKemia, CK samples were analyzed in 6904 individuals participating in the 6th survey of The Tromsø Study. URL was defined as the 97.5 percentile.New URL in women was 207 U/L. In men <50 years it was 395 U/L and in men ≥50 years 340 U/L. In individuals with elevated CK, normalization grade after control analysis was inversely correlated to the CK level (p<0.04).URL CK values in women and in men <50 years of age were in accordance with URL CK values given by the NORIP. In men ≥50 years, a higher URL was found and the findings suggest an upward adjustment of URL in this age group.


2019 ◽  
Vol 57 (9) ◽  
pp. 1382-1387
Author(s):  
Seungok Lee ◽  
Chui Mei Ong ◽  
Yu Zhang ◽  
Alan H.B. Wu

Abstract Background Biological variation studies have shown that the complete blood count (CBC) has narrow within-individual variation and wide group variation, indicating that the use of reference intervals (RIs) is challenging. The aim of this study was to examine differences in CBC RIs according to race/ethnicity in a multiethnic population at a hospital in San Francisco in hopes of improving the medical utility of CBC testing. Methods Subject data were obtained by screening CBC results from the medical records of outpatients meeting certain criteria who visited Zuckerberg San Francisco General Hospital from April 2017 to January 2018. From these records, sex- and race/ethnicity-specific CBC RIs were calculated as the 2.5th to 97.5th percentiles. Results From a total of 552 subjects, 47.9% were male (65 White, 50 Black, 71 Hispanic and 54 Asian) and 52.1% were female (51 White, 39 Black, 122 Hispanic and 72 Asian). The RIs of neutrophil, lymphocyte and eosinophil counts; and hemoglobin, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC) showed significant differences (p<0.05) among the four racial/ethnic groups: neutrophil, lymphocyte and eosinophil counts; and MCHC in males, and hemoglobin, MCV, MCH and MCHC in females. Conclusions Race/ethnicity-specific CBC RIs should be taken into consideration in a multiethnic population to better interpret patient status and make progress toward precision medicine.


Author(s):  
Jiming Li ◽  
Huifen Zhang ◽  
Haichen Chen ◽  
Yuebin Gan ◽  
Juan Li ◽  
...  

Background To date, China has no industry standard for reference intervals of paediatric blood biochemical markers. This study aimed to evaluate changes in biochemical markers in the venous blood of healthy children aged 29 days to 12 years, derived from the UniCel DxC 800 system, and establish appropriate reference intervals. Methods We analysed venous blood from 1980 healthy children for 20 biochemical markers. Reference intervals were established according to the Clinical and Laboratory Standards Institute C28-A3c guideline and compared with those of adults in China. Results All markers except for sodium and chlorine required partitioning by age, but not by sex. The reference intervals of total protein, albumin, globulin, carbon dioxide, urea nitrogen, creatinine and uric acid consistently increased with age in children, but were always lower than those of adults. Children aged 29 days to 12 years had a single combined RI for sodium and chloride, respectively; although the reference intervals in children were similar to those of adults, their upper limits were lower. The reference intervals of direct bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, potassium, calcium, magnesium, and phosphorus continued to decline with age. The reference intervals of total bilirubin, indirect bilirubin, and gamma-glutamyl transpeptidase initially declined followed by a slight rebound. Conclusions While establishing reference intervals, most markers required partitioning by age (aged 29 days to 12 years); the partitioning scheme differed for each marker, and paediatric reference intervals differed from those for adults. It is therefore necessary to establish separate paediatric reference intervals.


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