Establishment of CA19-9 reference intervals in an apparently healthy adult population in Singapore.

IF 2.1 4区医学 Q3 MEDICAL LABORATORY TECHNOLOGY

Annals of Clinical Biochemistry Pub Date : 2024-07-01 Epub Date: 2023-12-26 DOI:10.1177/00045632231224216

Joanne Mee Yin Lee, Pearline Teo, Leslie Choong Weng Lam

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引用次数: 0

Abstract

Background: CA19-9 is elevated in pancreatic cancer and other malignancies, and commonly used in clinical practice. Unfortunately, CA19-9 immunoassays are not harmonized, and reference intervals may differ between assays. The aim of this study was to establish the reference interval of the ADVIA Centaur/Atellica IM CA19-9 assay in an apparently healthy Singapore adult population.

Methods: This is a retrospective cross-sectional study. De-identified data from Health Screening participants were extracted from our database. Subjects with biochemical results suggesting anaemia, diabetes mellitus, viral hepatitis or abnormal liver, and renal and tumour markers were excluded. Outlier and subclass analyses by age and sex were performed. CA19-9 reference limits and 90% confidence intervals were then determined for candidate subclasses.

Results: Data from 12,174 subjects (5846 males and 6328 females) were available after exclusion criteria were applied. CA19-9 results did not follow a normal distribution and were higher in females compared to males (P < .001). Although CA19-9 means were statistically different between certain age groups, the evaluable 99th percentile reference limits were not statistically different. The overall 99th percentile reference limits for the Centaur/Atellica CA19-9 assay was 37 U/mL for males 21-80 years, and 60 U/mL for females 21-80 years.

Conclusions: Our results suggest that separate CA19-9 reference intervals should be applied for males and females.

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在新加坡明显健康的成年人群中建立 CA19-9 参考区间。

背景：CA19-9 在胰腺癌和其他恶性肿瘤中升高，在临床实践中常用。遗憾的是，CA19-9 免疫测定方法并不统一，不同检测方法的参考区间也可能不同。本研究的目的是在表面健康的新加坡成年人群中确定 ADVIA Centaur/ Atellica IM CA19-9 检测法的参考区间：这是一项回顾性横断面研究。方法：这是一项回顾性横断面研究。我们从数据库中提取了健康筛查参与者的去身份化数据。排除了生化结果显示贫血、糖尿病、病毒性肝炎或肝脏、肾脏和肿瘤标志物异常的受试者。按年龄和性别进行了离群分析和亚类分析。然后确定候选亚类的 CA19-9 参考限值和 90% 置信区间：应用排除标准后，共获得了 12174 名受试者（男性 5846 人，女性 6328 人）的数据。CA19-9结果不呈正态分布，女性高于男性（p结论：我们的结果表明，单独的CA19-9和CA19-9亚类之间存在差异：我们的研究结果表明，男性和女性的 CA19-9 参考区间应有所区别。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of Clinical Biochemistry Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry

CiteScore

5.20

自引率

4.50%

发文量

期刊介绍： Annals of Clinical Biochemistry is the fully peer reviewed international journal of the Association for Clinical Biochemistry and Laboratory Medicine. Annals of Clinical Biochemistry accepts papers that contribute to knowledge in all fields of laboratory medicine, especially those pertaining to the understanding, diagnosis and treatment of human disease. It publishes papers on clinical biochemistry, clinical audit, metabolic medicine, immunology, genetics, biotechnology, haematology, microbiology, computing and management where they have both biochemical and clinical relevance. Papers describing evaluation or implementation of commercial reagent kits or the performance of new analysers require substantial original information. Unless of exceptional interest and novelty, studies dealing with the redox status in various diseases are not generally considered within the journal''s scope. Studies documenting the association of single nucleotide polymorphisms (SNPs) with particular phenotypes will not normally be considered, given the greater strength of genome wide association studies (GWAS). Research undertaken in non-human animals will not be considered for publication in the Annals. Annals of Clinical Biochemistry is also the official journal of NVKC (de Nederlandse Vereniging voor Klinische Chemie) and JSCC (Japan Society of Clinical Chemistry).