{"title":"The Role and Limitations of the Reference Interval Within Clinical Chemistry and Its Reliability for Disease Detection.","authors":"Nathan E Timbrell","doi":"10.3389/bjbs.2024.12339","DOIUrl":null,"url":null,"abstract":"<p><p>Reference intervals (RIs) are a range of values that are supplied alongside laboratory measurements for comparison to allow interpretation of this data. Historically, RIs were referred to as the normal range. However, the perception of what is normal can lead to confusion in clinicians and unnecessary emotional distress in patients. RIs can be acquired using several methods. Laboratories may quote published studies or derive their own using established direct or indirect methods. Alternatively, laboratories may verify RIs provided by assay manufacturers using in-house studies. RIs have several limitations that clinicians should be aware of. The statistical methodology associated with establishment of RIs means that approximately 5% of \"disease free\" individuals will fall outside the RI. Additionally, the higher the number of tests requested, the higher the probability that one will be abnormal, and repeat results in an individual may show regression to the mean. Completion of studies for establishment of RIs can be expensive, difficult, and time consuming. Method bias and differences in populations can greatly influence RIs and prevent them from being transferable between some laboratories. Differences in individual characteristics such as age, ethnicity, and sex can result in large variation in some analytes. Some patients, such as those whose gender differs from that which was presumed for them at birth, may require their own RIs. Alternatively, a decision will need to be made about which to use. Overall, the issue common to these factors lies within interpretation. As such, RIs can be improved with better training in their use, combined with a better understanding of influences that affect them, and more transparent communication from laboratories in how RIs were derived.</p>","PeriodicalId":9236,"journal":{"name":"British Journal of Biomedical Science","volume":null,"pages":null},"PeriodicalIF":2.7000,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10932992/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"British Journal of Biomedical Science","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3389/bjbs.2024.12339","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Reference intervals (RIs) are a range of values that are supplied alongside laboratory measurements for comparison to allow interpretation of this data. Historically, RIs were referred to as the normal range. However, the perception of what is normal can lead to confusion in clinicians and unnecessary emotional distress in patients. RIs can be acquired using several methods. Laboratories may quote published studies or derive their own using established direct or indirect methods. Alternatively, laboratories may verify RIs provided by assay manufacturers using in-house studies. RIs have several limitations that clinicians should be aware of. The statistical methodology associated with establishment of RIs means that approximately 5% of "disease free" individuals will fall outside the RI. Additionally, the higher the number of tests requested, the higher the probability that one will be abnormal, and repeat results in an individual may show regression to the mean. Completion of studies for establishment of RIs can be expensive, difficult, and time consuming. Method bias and differences in populations can greatly influence RIs and prevent them from being transferable between some laboratories. Differences in individual characteristics such as age, ethnicity, and sex can result in large variation in some analytes. Some patients, such as those whose gender differs from that which was presumed for them at birth, may require their own RIs. Alternatively, a decision will need to be made about which to use. Overall, the issue common to these factors lies within interpretation. As such, RIs can be improved with better training in their use, combined with a better understanding of influences that affect them, and more transparent communication from laboratories in how RIs were derived.
参考区间(RIs)是与实验室测量结果一起提供的数值范围,用于比较以解释这些数据。从历史上看,参考区间被称为正常范围。然而,对正常值的认识可能会导致临床医生的困惑和患者不必要的情绪困扰。RIs 可通过多种方法获得。实验室可引用已发表的研究报告,或使用已确立的直接或间接方法自行推导。另外,实验室也可以通过内部研究来验证化验生产商提供的 RIs。RIs 有几个局限性,临床医生应加以注意。与确定 RI 相关的统计方法意味着约有 5% 的 "无病 "个体会在 RI 范围之外。此外,要求进行的检测次数越多,其中一次出现异常的概率就越高,而且一个人的重复检测结果可能会向平均值回归。完成用于确定 RI 的研究可能既昂贵、困难又耗时。方法偏差和人群差异会极大地影响 RIs,并使其无法在某些实验室之间转移。年龄、种族和性别等个体特征的差异会导致某些分析物的差异很大。有些患者,如性别与出生时的假定性别不同的患者,可能需要自己的 RI。另外,还需要决定使用哪种 RI。总之,这些因素的共同问题在于解释。因此,如果在使用 RI 方面进行更好的培训,同时更好地了解影响 RI 的各种因素,并让实验室就如何得出 RI 进行更透明的交流,那么 RI 就能得到改善。
期刊介绍:
The British Journal of Biomedical Science is committed to publishing high quality original research that represents a clear advance in the practice of biomedical science, and reviews that summarise recent advances in the field of biomedical science. The overall aim of the Journal is to provide a platform for the dissemination of new and innovative information on the diagnosis and management of disease that is valuable to the practicing laboratory scientist.