Reference intervals for 33 biochemical analytes in healthy Indian population: C-RIDL IFCC initiative
Reference intervals for 33 biochemical analytes in healthy Indian population: C-RIDL IFCC initiative
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DOI：
10.1515/cclm-2018-0152
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发表时间：
2018-12-01
影响因子：
6.8
通讯作者：
Ashavaid, Tester F.
中科院分区：
文献类型：
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作者：
Shah, Swarup A. V.;Ichihara, Kiyoshi;Ashavaid, Tester F.
背景资料：2011年，IFCC参考区间和决策限委员会（C-RIDL）发起了一项关于参考值的全球多中心研究，以促进国家特定参考区间（RI）的实施。印度还没有精心设计的RI研究。本研究的目的是推导出33个主要生化分析物在精心挑选的健康印度人定义的C-RIDL protocol.Methods：共招募了512名健康印度人的RI。对从过夜空腹血样中采集的血清进行分析物的总体测量。采用多元回归分析（MRA）和巢式方差分析（ANOVA）确定试验结果的潜在变异来源（SV）。通过参数和非参数方法推导RI以进行比较。潜在异常值排除法（LAVE）的二次排除的需要进行了examined.Results：MRA结果表明，年龄和BMI的许多分析物在两性明显SV。ANOVA显示，需要按性别和年龄对17种分析物（TC、HDL-C、TG、hsCRP、ALB、AST、ALT、ALP、GGT、TBil、尿素、CRE、UA、Fe、TTR、CK和IgM）和5种分析物（Glu、ALB、TC、ALP和尿素）进行RI划分。参数方法的RI通常比非参数方法窄，反映了测试结果的扭曲的外围分布。LAVE方法对RI没有明显的影响，可能是由于相关分析物异常值之间的不一致性。结论：这项研究首次提供了全面的RI信息在健康的印度人。采用的最终RI是通过参数方法而非LAVE程序获得的RI。
Background: In 2011, the IFCC Committee on Reference Intervals and Decision Limits (C-RIDL) initiated a worldwide multicenter study on references values facilitating the implementation of country-specific reference intervals (RIs). There has been no well-designed RI study in India. This study aims to derive RIs for 33 major biochemical analytes in carefully selected healthy Indians as defined in C-RIDL protocol.Methods: A total of 512 healthy Indians were recruited. Sera collected from overnight fasting blood samples were measured collectively for the analytes. Multiple regression analysis (MRA) and nested analysis of variance (ANOVA) were used to identify the potential sources of variation (SV) of test results. RI were derived by both parametric and non-parametric methods for comparison. The need for secondary exclusion by latent abnormal values exclusion (LAVE) method was examined.Results: MRA results indicated that both age and BMI were apparent SV for many analytes in both sexes. ANOVA revealed that partition of RIs by gender and age was required for 17 analytes (TC, HDL-C, TG, hsCRP, ALB, AST, ALT, ALP, GGT, TBil, Urea, CRE, UA, Fe, TTR, CK and IgM) and 5 (Glu, ALB, TC, ALP and Urea), respectively. RIs by parametric method were generally narrower than by non-parametric method, reflecting distorted peripheral distributions of test results. The LAVE method had no appreciable effect on RIs possibly due to inconsistency among abnormal values of related analytes.Conclusions: This study has for the first time provided comprehensive RIs information in healthy Indians. The final RIs adopted were those derived by parametric method without LAVE procedure.