Pre-analytical stability of the CEA, CYFRA 21.1, NSE, CA125 and HE4 tumor markers.

Q3 Biochemistry, Genetics and Molecular Biology Tumor Biology Pub Date : 2024-01-01 DOI:10.3233/TUB-220013

Esra Canki, Milou Mf Schuurbiers, Theodora C Linders, Catharina M Korse, Michel M van den Heuvel, Antonius E van Herwaarden, Huub H van Rossum

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Abstract

Background: For lung cancer, circulating tumor markers (TM) are available to guide clinical treatment decisions. To ensure adequate accuracy, pre-analytical instabilities need to be known and addressed in the pre-analytical laboratory protocols.

Objective: This study investigates the pre-analytical stability of CA125, CEA, CYFRA 21.1, HE4 and NSE for the following pre-analytical variables and procedures; i) whole blood stability, ii) serum freeze-thaw cycles, iii) electric vibration mixing and iv) serum storage at different temperatures.

Methods: Left-over patient samples were used and for every investigated variable six patient samples were used and analysed in duplicate. Acceptance criteria were based on analytical performance specifications based on biological variation and significant differences with baseline.

Results: Whole blood was stable for at least 6 hours for all TM except for NSE. Two freeze-thaw cycles were acceptable for all TM except CYFRA 21.1. Electric vibration mixing was allowed for all TM except for CYFRA 21.1. Serum stability at 4°C was 7 days for CEA, CA125, CYFRA 21.1 and HE4 and 4 hours for NSE.

Conclusions: Critical pre-analytical processing step conditions were identified that, if not taken into account, will result in reporting of erroneous TM results.

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CEA、CYFRA 21.1、NSE、CA125 和 HE4 肿瘤标志物分析前的稳定性。

背景：对于肺癌，循环肿瘤标志物（TM）可用于指导临床治疗决策。为确保足够的准确性，需要了解分析前的不稳定性，并在分析前实验室规程中加以解决：本研究调查了 CA125、CEA、CYFRA 21.1、HE4 和 NSE 在以下分析前变量和程序下的分析前稳定性：i) 全血稳定性；ii) 血清冻融循环；iii) 电振混合；iv) 血清在不同温度下的储存：方法：使用病人的剩余样本，对每个调查变量使用六份病人样本进行重复分析。验收标准以生物变异和与基线的显著差异为基础的分析性能指标为依据：除 NSE 外，所有 TM 的全血在至少 6 小时内都是稳定的。除 CYFRA 21.1 外，所有 TM 均可接受两次冻融循环。除 CYFRA 21.1 外，所有 TM 均可进行电动振动混合。CEA、CA125、CYFRA 21.1 和 HE4 在 4°C 下的血清稳定性为 7 天，NSE 为 4 小时：结论：确定了分析前处理步骤的关键条件，如果不加以考虑，将导致报告错误的 TM 结果。

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

Tumor Biology 医学-肿瘤学

CiteScore

5.40

自引率

0.00%

发文量

审稿时长

1 months

期刊介绍： Tumor Biology is a peer reviewed, international journal providing an open access forum for experimental and clinical cancer research. Tumor Biology covers all aspects of tumor markers, molecular biomarkers, tumor targeting, and mechanisms of tumor development and progression. Specific topics of interest include, but are not limited to: Pathway analyses, Non-coding RNAs, Circulating tumor cells, Liquid biopsies, Exosomes, Epigenetics, Cancer stem cells, Tumor immunology and immunotherapy, Tumor microenvironment, Targeted therapies, Therapy resistance Cancer genetics, Cancer risk screening. Studies in other areas of basic, clinical and translational cancer research are also considered in order to promote connections and discoveries across different disciplines. The journal publishes original articles, reviews, commentaries and guidelines on tumor marker use. All submissions are subject to rigorous peer review and are selected on the basis of whether the research is sound and deserves publication. Tumor Biology is the Official Journal of the International Society of Oncology and BioMarkers (ISOBM).