A global multicenter study on reference values: 1. Assessment of methods for derivation and comparison of reference intervals

Autor: Yoshihisa Shimizu, Dilshad Khan, Shogo Kimura, Ling Qiu, Yesim Ozarda, Svetlana Evgina, George G. Klee, Reynan Rolle, Kazuo Mori, Rajiv T Erasmus, Reo Kawano, David A. Armbruster, Kiyoshi Ichihara, Laura Schreier, Tester F. Ashavaid, Binod Kumar Yadav, Julian H. Barth, Anwar Borai
Přispěvatelé: Uludağ Üniversitesi/Tıp Fakültesi/Biyokimya Anabilim Dalı., Özarda, Ozarda, Yesim Yesim, AAL-8873-2021
Rok vydání: 2016
Předmět:
Serum
Male
030213 general clinical medicine
Internationality
Clinical Biochemistry
Normal Distribution
030204 cardiovascular system & hematology
Common biochemical analytes
Feasibility study
Biochemistry
Plasma
0302 clinical medicine
Nutritional status
Reference Values
Statistics
Clinical Chemistry
Thyrotropin
Chemical Species
Parametric statistics
Mathematics
Tests
Latent abnormal values exclusion method
Ethnic difference
General Medicine
Reference preparation crm470
Multicenter study
Healthy Volunteers
Normal human
Clinical trial
Variable (computer science)
Muscle exercise
Body mass
Modified Box-Cox power transformation
Female
Standard deviation ratio
Human
Adult
Laboratory test
Standards
Strategy
Data analysis
Article
Validity
Neference value
Normal distribution
03 medical and health sciences
Collaborative derivation
Laboratory technique
Ethnic differences
Reference individuals
Analytic method
Humans
Aged
Protocol (science)
Serum panel
Inflammation
Biochemistry
medical
Clinical Laboratory Techniques
Biochemistry (medical)
Nonparametric statistics
Reference intervals
Worldwide multicenter
Standardization
6 asian cities
Harmonization
Reference values
Latent abnormal values exclusion
Medical laboratory technology
International cooperation
Reference value
Zdroj: Clinica Chimica Acta.
ISSN: 0009-8981
DOI: 10.1016/j.cca.2016.09.016
Popis: Objectives: The IFCC Committee on Reference Intervals and Decision Limits coordinated a global multicenter study on reference values (RVs) to explore rational and harmonizable procedures for derivation of reference intervals (Rls) and investigate the feasibility of sharing RIs through evaluation of sources of variation of RVs on a global scale. Methods: For the common protocol, rather lenient criteria for reference individuals were adopted to facilitate harmonized recruitment with planned use of the latent abnormal values exclusion (LAVE) method. As of July 2015, 12 countries had completed their study with total recruitment of 13,386 healthy adults. 25 analytes were measured chemically and 25 immunologically. A serum panel with assigned values was measured by all laboratories. Rls were derived by parametric and nonparametric methods. Results: The effect of LAVE methods is prominent in analytes which reflect nutritional status, inflammation and muscular exertion, indicating that inappropriate results are frequent in any country. The validity of the parametric method was confirmed by the presence of analyte-specific distribution patterns and successful Gaussian transformation using the modified Box-Cox formula in all countries. After successful alignment of RVs based on the panel test results, nearly half the analytes showed variable degrees of between-country differences. This finding, however, requires confirmation after adjusting for BMI and other sources of variation. The results are reported in the second part of this paper. Conclusion: The collaborative study enabled us to evaluate rational methods for deriving Rls and comparing the RVs based on real-world datasets obtained in a harmonized manner. Ministry of Education, Culture, Sports, Science and Technology, Japan (MEXT) Japan Society for the Promotion of Science - 24256003
Databáze: OpenAIRE
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