Establishment of sex-specific reference intervals for PIVKA-II in Southwest China: A real-world data analysis.

IF 2.1 4区医学 Q3 MEDICAL LABORATORY TECHNOLOGY

Annals of Clinical Biochemistry Pub Date : 2024-12-06 DOI:10.1177/00045632241306074

Bin Wei, Yalin Zheng, Lixin Li, Limei Luo, Ying Guo

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引用次数: 0

Abstract

Objective: We aim to establish the sex-related reference intervals (RIs) of PIVKA-II in southwest China by indirect method with the real-world data.

Methods: Between 29 July 2016 and 5 February 2024, PIVKA-II test data were collected from 120,780 healthy adult participants (aged 18 to 97 years) in the Laboratory Information System (LIS) of West China Hospital to establish reference intervals. Additionally, a validation group comprised of 2068 healthy adults was evaluated using the same detection algorithm and platform. Following the CLSI EP28-A3 guideline, Box-Cox transformation was applied for normal transformation, and outliers were identified using the Tukey method. Furthermore, we employed the standard normal deviate test (z-test) recommended by Harris and Boyd to determine whether to stratify reference intervals by age and sex subclasses.

Results: We successfully established population-specific RI for PIVKA-II in southwest China using an indirect method. By utilizing a robust dataset and conducting rigorous statistical analyses, we delineated sex-specific RIs, with values of 0-35 mAU/mL for males and 0-29 mAU/mL for females according to the normal distribution method, and 0-32 mAU/mL for males and 0-28 mAU/mL for females using the non-parametric method. These intervals are more suitable for the local population than those derived from manual methods.

Conclusion: These RIs provide valuable guidance for the accurate interpretation of PIVKA-II levels in the local population.

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中国西南地区PIVKA-II性别特异性参考区间的建立：一个真实世界的数据分析。

目的：利用实际数据，采用间接方法建立中国西南地区PIVKA-II的性别相关参考区间（RIs）。方法：于2016年7月29日至2024年2月5日，在华西医院实验室信息系统（LIS）中收集120,780名18 ~ 97岁健康成人受试者的PIVKA-II检测数据，建立参考区间。此外，使用相同的检测算法和平台对由2068名健康成年人组成的验证组进行评估。按照CLSI EP28-A3指南，采用Box-Cox变换进行正态变换，采用Tukey法识别异常值。此外，我们采用Harris和Boyd推荐的标准正态偏差检验（z检验）来确定是否按年龄和性别亚类对参考区间进行分层。结果：采用间接方法成功建立了中国西南地区PIVKA-II人群特异性RI。通过使用稳健的数据集并进行严格的统计分析，我们描绘了性别特异性的RIs，根据正态分布方法，男性的值为0-35 mAU/mL，女性为0-29 mAU/mL，使用非参数方法，男性为0-32 mAU/mL，女性为0-28 mAU/mL。这些区间比人工方法得到的区间更适合当地人口。结论：这些RIs为准确解释当地人群的PIVKA-II水平提供了有价值的指导。

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).