Reference intervals: current status, recent developments and future considerations.

Reference intervals: current status, recent developments and future considerations.
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DOI:
10.11613/bm.2016.001
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发表时间:
2016
期刊:
影响因子:
3.3
通讯作者:
Ozarda Y
Ozarda Y
中科院分区:
医学4区
文献类型:
--
作者:
Ozarda Y

文献摘要

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实验室分析的可靠和准确的参考区间(RI)是正确解释临床实验室检查结果过程中不可或缺的一部分。实验室报告中给出的RI在帮助临床医生解释健康人群的检测结果方面具有重要作用。自20世纪80年代以来,国际临床化学联合会(IFCC)一直积极制定建议,以澄清术语“RI”的真正意义,选择适当的参考人群并对数据进行统计分析。临床和实验室标准化协会(CLSI)和IFCC发布的C28-A3指南仍然是该领域最广泛使用的参考来源。近年来,IFCC参考区间和决策限委员会(C-RIDL)发布了该指南的附加方案,包括RI多中心研究的所有细节,以满足该领域的要求。多中心研究是研究领域最重要的进展。最近,C-RIDL进行了许多多中心研究,以获得常见的RI。RI和临床决策限(CDLs)的混淆仍然是一个问题,儿科和老年年龄组是一个重要问题。对于未来的研究的RI,遗传效应似乎是最具挑战性的areag. The目的的审查是目前的理论和实践的RI,特别强调给予多中心的RI研究,RI研究的儿科和老年人的年龄组,临床决策限制和分区的遗传效应的RI。

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term ‘RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area.
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs.