Establishment of Pediatric Reference Intervals for Routine Laboratory Tests in Korean Population: A Retrospective Multicenter Analysis

Background Reference intervals defined for adults or children of other ethnicities cannot be applied in the evaluation of Korean pediatric patients. Pediatric reference intervals are difficult to establish because children are in their growing stage and their physiology changes continuously. We aimed to establish reference intervals for routine laboratory tests for Korean pediatric patients through retrospective multicenter data analysis. Methods Preoperative laboratory test results from 1,031 pediatric patients aged 0 month–18 years who underwent minor surgeries in four university hospitals were collected. Age- and sex-specific reference intervals for routine laboratory tests were defined based on the Clinical and Laboratory Standards Institute (CLSI) EP28-A3c guidelines. Results The pediatric reference intervals determined in this study were different from existing adult reference intervals and pediatric reference intervals for other ethnicities. Most tests required age-specific partitioning, and some of those required sex-specific partitioning for at least one age-partitioned subgroup. Erythrocyte sedimentation rate, monocyte percentage, basophil percentage, activated partial thromboplastin time, glucose, cholesterol, albumin, bilirubin, chloride, and C-reactive protein did not show any difference between age- or sex-partitioned subgroups. Conclusions We determined Korean pediatric reference intervals for hematology, coagulation, and chemistry tests by indirect sampling based on medical record data from multiple institutions. These reference intervals would be valuable for clinical evaluations in the Korean pediatric population.

[1]  K. Adeli,et al.  Influence of ethnicity on biochemical markers of health and disease in the CALIPER cohort of healthy children and adolescents , 2019, Clinical chemistry and laboratory medicine.

[2]  Lan Nguyen,et al.  Indirect Reference Intervals: Harnessing the Power of Stored Laboratory Data. , 2019, The Clinical biochemist. Reviews.

[3]  Suyoung Kim,et al.  Complete Blood Count Reference Intervals and Patterns of Changes Across Pediatric, Adult, and Geriatric Ages in Korea , 2018, Annals of laboratory medicine.

[4]  Julian H Barth,et al.  Indirect methods for reference interval determination – review and recommendations , 2018, Clinical chemistry and laboratory medicine.

[5]  J. Chang,et al.  Reference Intervals of Hematology and Clinical Chemistry Analytes for 1-Year-Old Korean Children , 2016, Annals of laboratory medicine.

[6]  Tara Sadeghieh,et al.  CLSI-based transference of CALIPER pediatric reference intervals to Beckman Coulter AU biochemical assays. , 2015, Clinical biochemistry.

[7]  Tara Sadeghieh,et al.  CLSI-based transference of the CALIPER database of pediatric reference intervals to Beckman Coulter DxC biochemical assays. , 2015, Clinical biochemistry.

[8]  Soo-Youn Lee,et al.  Dried Blood Spot Testing for Seven Steroids Using Liquid Chromatography-Tandem Mass Spectrometry With Reference Interval Determination in the Korean Population , 2015, Annals of laboratory medicine.

[9]  M. Rauh,et al.  Age- and sex-specific dynamics in 22 hematologic and biochemical analytes from birth to adolescence. , 2015, Clinical chemistry.

[10]  Jeong-Ho Kim,et al.  Establishing pediatric reference intervals for 13 biochemical analytes derived from normal subjects in a pediatric endocrinology clinic in Korea. , 2014, Clinical biochemistry.

[11]  Khosrow Adeli,et al.  Validity of establishing pediatric reference intervals based on hospital patient data: a comparison of the modified Hoffmann approach to CALIPER reference intervals obtained in healthy children. , 2012, Clinical biochemistry.

[12]  Khosrow Adeli,et al.  CLSI-based transference of the CALIPER database of pediatric reference intervals from Abbott to Beckman, Ortho, Roche and Siemens Clinical Chemistry Assays: direct validation using reference samples from the CALIPER cohort. , 2013, Clinical biochemistry.

[13]  K. Adeli,et al.  Marked biological variance in endocrine and biochemical markers in childhood: establishment of pediatric reference intervals using healthy community children from the CALIPER cohort. , 2013, Clinical chemistry.

[14]  K. Adeli,et al.  Pediatric reference intervals: Challenges and recent initiatives , 2013, Critical reviews in clinical laboratory sciences.

[15]  Anders Kallner,et al.  Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition , 2013 .

[16]  K. Adeli,et al.  Closing the gaps in pediatric laboratory reference intervals: a CALIPER database of 40 biochemical markers in a healthy and multiethnic population of children. , 2012, Clinical chemistry.

[17]  F. Ceriotti Establishing pediatric reference intervals: a challenging task. , 2012, Clinical chemistry.

[18]  K. Adeli Closing the gaps in pediatric reference intervals: the CALIPER initiative. , 2011, Clinical Biochemistry.

[19]  M. Thamm,et al.  KiGGS-the German survey on children's health as data base for reference intervals. , 2011, Clinical biochemistry.

[20]  W. Roberts,et al.  Age and gender specific pediatric reference intervals for aldolase, amylase, ceruloplasmin, creatine kinase, pancreatic amylase, prealbumin, and uric acid. , 2011, Clinica chimica acta; international journal of clinical chemistry.

[21]  K. Adeli,et al.  Clinical laboratory reference intervals in pediatrics: the CALIPER initiative. , 2009, Clinical biochemistry.

[22]  K. Adeli,et al.  Canadian Laboratory Initiative on Pediatric Reference Interval Database (CALIPER): pediatric reference intervals for an integrated clinical chemistry and immunoassay analyzer, Abbott ARCHITECT ci8200. , 2009, Clinical biochemistry.

[23]  R. Haeckel,et al.  An improved indirect approach for determining reference limits from intra-laboratory data bases exemplified by concentrations of electrolytes / Ein verbesserter indirekter Ansatz zur Bestimmung von Referenzgrenzen mittels intra-laboratorieller Datensätze am Beispiel von Elektrolyt-Konzentrationen , 2009 .

[24]  K. Adeli,et al.  3. Pediatric Reference Intervals: Critical Gap Analysis and Establishment of a National Initiative , 2008, EJIFCC.

[25]  K. Adeli,et al.  Closing the gaps in paediatric reference intervals: the CALIPER initiative. , 2008, The Clinical biochemist. Reviews.

[26]  Gert B. M. Mensink,et al.  The challenge of comprehensively mapping children's health in a nation-wide health survey: Design of the German KiGGS-Study , 2008, BMC public health.

[27]  Pediatric reference intervals: critical gap analysis and establishment of a national initiative. , 2006, Clinical biochemistry.

[28]  H. E. Solberg,et al.  Detection of outliers in reference distributions: performance of Horn's algorithm. , 2005, Clinical chemistry.

[29]  G. Rodgers,et al.  Pediatric reference intervals for seven common coagulation assays. , 2005, Clinical chemistry.

[30]  Amadeo J Pesce,et al.  Reference intervals: an update. , 2003, Clinica chimica acta; international journal of clinical chemistry.

[31]  P. S. Horn,et al.  A robust approach to reference interval estimation and evaluation. , 1998, Clinical chemistry.

[32]  E. Moran,et al.  Relationship between alkaline phosphatase levels, osteopontin expression, and mineralization in differentiating MC3T3‐E1 osteoblasts , 1998, Journal of cellular biochemistry.

[33]  H E Solberg,et al.  Using a hospitalized population to establish reference intervals: pros and cons. , 1994, Clinical chemistry.

[34]  G. Stein,et al.  Relationship of cell growth to the regulation of tissue‐specific gene expression during osteoblast differentiation , 1990, FASEB journal : official publication of the Federation of American Societies for Experimental Biology.

[35]  R. Hoffmann STATISTICS IN THE PRACTICE OF MEDICINE. , 1963, JAMA.