Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea; Department of Laboratory Medicine, Keimyung University School of Medicine, Daegu, South Korea.
Clin Chim Acta. 2024 Sep 15;563:119902. doi: 10.1016/j.cca.2024.119902. Epub 2024 Aug 5.
Tumor markers should be measured regularly and accurately to prevent, diagnose, and monitor cancers efficiently. We aimed to characterize the pre-analytical factors effecting on the analytical performance of point-of-care test (POCT) platform Ichroma II (Boditech Med Inc., Gangwon-do, Korea) for alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), and prostate specific antigen (PSA) and evaluate their consequences in clinical practice. Based on comprehensive evaluation for the analytical performance of Ichroma II including precision, linearity, and method comparison performed according to CLSI guidelines, pre-analytical factors of sample types and conditions were extensively analyzed. A total of five sample types [serum, plasma (PL) and whole blood (WB) from EDTA tube, PL and WB from sodium heparin tube] from 40 patients were used for comparing among specimen types. Additionally, stability was assessed up to 21 h at room temperature, refrigerated for 8 days, and frozen for 16 weeks by using 4 levels of pooled patient samples which were measured in triplicate. Precision, linearity and correlation with central laboratory analyzers observed in all three tumor markers were within acceptable criteria. However, variable degrees of percent deviations were observed according to sample type and storage conditions. Only EDTA PL samples presented clinically acceptable percentage biases for all three tumor markers when stored at room temperature or refrigerated condition. Positive bias of CEA and PSA in storage duration until 16 weeks were observed when stored in frozen condition. While Ichroma II showed an adequate analytical performance as a POCT platform with simple operating procedures for the measurement of tumor markers, clinical laboratories should be aware of stability issues when different types of blood specimens are practically utilized.
肿瘤标志物应定期、准确地测量，以有效地预防、诊断和监测癌症。我们旨在描述影响即时检验（POCT）平台 Ichroma II（Boditech Med Inc.，江原道，韩国）分析性能的分析前因素，用于检测甲胎蛋白（AFP）、癌胚抗原（CEA）和前列腺特异抗原（PSA），并评估其在临床实践中的后果。根据 CLSI 指南进行的 Ichroma II 分析性能全面评估，包括精密度、线性和方法比较，广泛分析了样本类型和条件的分析前因素。总共使用了来自 40 名患者的五种样本类型[血清、EDTA 管中的血浆（PL）和全血（WB）、肝素钠管中的 PL 和 WB]来比较不同样本类型之间的差异。此外，通过使用 4 个水平的混合患者样本，评估了在室温下长达 21 小时、冷藏 8 天和冷冻 16 周的稳定性，这些样本在重复测量时均测量了 3 次。所有三种肿瘤标志物的精密度、线性和与中心实验室分析仪的相关性均符合可接受标准。然而，根据样本类型和储存条件，观察到不同程度的百分比偏差。只有 EDTA PL 样本在室温或冷藏条件下储存时，所有三种肿瘤标志物的临床可接受百分比偏差。在冷冻条件下储存 16 周时，CEA 和 PSA 的储存时间观察到正偏差。虽然 Ichroma II 作为一种具有简单操作程序的 POCT 平台，用于肿瘤标志物的测量，具有良好的分析性能，但临床实验室在实际使用不同类型的血液样本时，应注意稳定性问题。
