{"title":"A Nationwide Nepalese Study to Establish Reference Intervals for Major Biochemical Analytes with Elucidation of Nepalese Features of Reference Values.","authors":"Ram Vinod Mahato, Kiyoshi Ichihara, Madhab Lamsal","doi":"10.1007/s12291-023-01123-6","DOIUrl":null,"url":null,"abstract":"<p><p>Despite immense importance of reference intervals (RIs) for clinical diagnosis, there have been no reliable RIs available for Nepalese. Hence, this nationwide study was organized to establish RIs for 30 common biochemical parameters. This study was conducted following the harmonized protocol provided by IFCC Committee on Reference Interval and Decision Limits (C-RIDL) with recruitment of 617 apparently healthy volunteers (18 - 65 years) by near-equal gender balance from 5 major cities. Fasting blood were collected, serum was separated and measured collectively using Beckman-Coulter/Olympus AU480 chemistry analyzer. The sources of variations of reference values (RVs) were evaluated by multiple regression analysis and nested ANOVA. Latent abnormal values exclusion (LAVE) method was applied to reduce influence of latent diseases. RIs were standardized based on a value-assigned serum panel provided by C-RIDL. By ANOVA, no between-city differences were observed, while sex-related changes were typically noted for urate, creatinine, iron, γ-glutamyl transferase (GGT), immunoglobulin M, and transferrin, but not for high-density lipoprotein cholesterol. Age-related changes were observed for total cholesterol (TC), triglyceride, low-density lipoprotein cholesterol, and C-reactive protein (CRP). RIs were successfully derived all parametrically. The LAVE procedure was effective in lowering upper limits for aspartate aminotransferase, alanine aminotransferase (ALT), and CRP. Compared to other collaborating countries, Nepalese RIs were low for urea, cholesterols, ALT, and high for triglyceride, GGT, CRP, immunoglobulin G, and complements. The RIs for major chemistry analytes were derived and standardized for nationwide use in Nepal. This study distinctly elucidated sources of variation and international features of Nepalese RIs.</p><p><strong>Supplementary information: </strong>The online version supplementary material available at 10.1007/s12291-023-01123-6.</p>","PeriodicalId":13280,"journal":{"name":"Indian Journal of Clinical Biochemistry","volume":null,"pages":null},"PeriodicalIF":1.5000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11239621/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian Journal of Clinical Biochemistry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s12291-023-01123-6","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/5/4 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Despite immense importance of reference intervals (RIs) for clinical diagnosis, there have been no reliable RIs available for Nepalese. Hence, this nationwide study was organized to establish RIs for 30 common biochemical parameters. This study was conducted following the harmonized protocol provided by IFCC Committee on Reference Interval and Decision Limits (C-RIDL) with recruitment of 617 apparently healthy volunteers (18 - 65 years) by near-equal gender balance from 5 major cities. Fasting blood were collected, serum was separated and measured collectively using Beckman-Coulter/Olympus AU480 chemistry analyzer. The sources of variations of reference values (RVs) were evaluated by multiple regression analysis and nested ANOVA. Latent abnormal values exclusion (LAVE) method was applied to reduce influence of latent diseases. RIs were standardized based on a value-assigned serum panel provided by C-RIDL. By ANOVA, no between-city differences were observed, while sex-related changes were typically noted for urate, creatinine, iron, γ-glutamyl transferase (GGT), immunoglobulin M, and transferrin, but not for high-density lipoprotein cholesterol. Age-related changes were observed for total cholesterol (TC), triglyceride, low-density lipoprotein cholesterol, and C-reactive protein (CRP). RIs were successfully derived all parametrically. The LAVE procedure was effective in lowering upper limits for aspartate aminotransferase, alanine aminotransferase (ALT), and CRP. Compared to other collaborating countries, Nepalese RIs were low for urea, cholesterols, ALT, and high for triglyceride, GGT, CRP, immunoglobulin G, and complements. The RIs for major chemistry analytes were derived and standardized for nationwide use in Nepal. This study distinctly elucidated sources of variation and international features of Nepalese RIs.
Supplementary information: The online version supplementary material available at 10.1007/s12291-023-01123-6.
期刊介绍：
The primary mission of the journal is to promote improvement in the health and well-being of community through the development and practice of clinical biochemistry and dissemination of knowledge and recent advances in this discipline among professionals, diagnostics industry, government and non-government organizations. Indian Journal of Clinical Biochemistry (IJCB) publishes peer reviewed articles that contribute to the existing knowledge in all fields of Clinical biochemistry, either experimental or theoretical, particularly deal with the applications of biochemistry, molecular biology, genetics, biotechnology, and immunology to the diagnosis, treatment, monitoring and prevention of human diseases. The articles published also include those covering the analytical and molecular diagnostic techniques, instrumentation, data processing, quality assurance and accreditation aspects of the clinical investigations in which chemistry has played a major role, or laboratory animal studies with biochemical and clinical relevance.
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