Clinical utility of personalized reference intervals for CEA in the early detection of oncologic disease.

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Débora Martínez-Espartosa, Estíbaliz Alegre, Hugo Casero-Ramírez, Jorge Díaz-Garzón, Pilar Fernández-Calle, Patricia Fuentes-Bullejos, Nerea Varo, Álvaro González
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Abstract

Objectives: Personalized reference intervals (prRI) have been proposed as a diagnostic tool for assessing measurands with high individuality. Here, we evaluate clinical performance of prRI using carcinoembryonic antigen (CEA) for cancer detection and compare it with that of reference change values (RCV) and other criteria recommended by clinical guidelines (e.g. 25 % of change between consecutive CEA results (RV25) and the cut-off point of 5 μg/L (CP5)).

Methods: Clinical and analytical data from 2,638 patients collected over 19 years were retrospectively evaluated. A total 15,485 CEA results were studied. For each patient, we calculated prRI and RCV using computer algorithms based on the combination of different strategies to assess the number of CEA results needed, consideration of one or two limits of reference interval and the intraindividual biological variation estimate (CVI) used: (a) publicly available (CVI-EU), (b) CVI calculated using an indirect method (CVI-NOO) and (c) within-person BV (CVP). For each new result identified falling outside the prRI, exceeding the RCV interval, RV25 or CP5, we searched for records identifying the presence of tumour at 3 and 12 months after the test. The sensitivity, specificity and predictive power of each strategy were calculated.

Results: PrRI approaches derived using CVI-EU, and both limits of reference interval achieve the best sensitivity (87.5 %) and NPV (99.3 %) at 3 and 12 months of all evaluated criteria. Only 3 results per patients are enough to calculate prRIs that reach this diagnostic performance.

Conclusions: PrRI approaches could be an effective tool to rule out new oncological findings during the active surveillance of patients.

CEA 个性化参考区间在早期检测肿瘤疾病中的临床实用性。
目的:个性化参考区间(prRI)已被提出作为一种诊断工具,用于评估高度个性化的测量指标。在此,我们评估了使用癌胚抗原(CEA)检测癌症的 prRI 的临床表现,并将其与参考变化值(RCV)和临床指南推荐的其他标准(如连续 CEA 结果之间 25% 的变化(RV25)和 5 μg/L 临界点(CP5))进行了比较:方法:对 19 年来收集的 2638 名患者的临床和分析数据进行了回顾性评估。共研究了 15,485 项 CEA 结果。对于每位患者,我们使用计算机算法计算 prRI 和 RCV,该算法基于不同策略的组合,以评估所需的 CEA 结果数量、参考区间的一个或两个限值以及所用的个体内生物变异估计值 (CVI):(a) 公开提供的 CVI(CVI-EU),(b) 使用间接方法计算的 CVI(CVI-NOO)和 (c) 人内生物变异(CVP)。对于每一个超出 prRI、超出 RCV 区间、RV25 或 CP5 的新结果,我们都会搜索检测后 3 个月和 12 个月的肿瘤存在记录。我们计算了每种策略的灵敏度、特异性和预测能力:结果:在所有评估标准中,使用 CVI-EU 和两个参考区间限值得出的 PrRI 方法在 3 个月和 12 个月时的灵敏度(87.5%)和 NPV(99.3%)都是最好的。每名患者只需 3 个结果就足以计算出达到这一诊断性能的 prRI:PrRI方法是在对患者进行积极监测期间排除新的肿瘤发现的有效工具。
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
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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