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降钙素和降钙素原 Elecsys 免疫分析在甲状腺髓样癌患者中的临床性能。

Clinical performance of calcitonin and procalcitonin Elecsys immunoassays in patients with medullary thyroid carcinoma.

机构信息

Clinic for Nuclear Medicine and Competence Centre for Thyroid Diseases, Imaging Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.

Clinic for Nuclear Medicine and Interdisciplinary Thyroid Centre, University Hospital and University of Zurich, Zurich, Switzerland.

出版信息

Clin Chem Lab Med. 2020 Oct 22;59(4):743-747. doi: 10.1515/cclm-2020-1424. Print 2021 Mar 26.

Abstract

OBJECTIVES

Medullary thyroid carcinoma (MTC) is caused by a malignant transformation in the parafollicular C-cells of the thyroid, where calcitonin (CT) is released. Nowadays, CT is the main tumor marker used in the diagnosis and follow-up of MTC patients. Nonetheless, procalcitonin (PCT) has recently been proposed as a useful complementary/alternative biomarker in MTC. Our aims were to investigate the diagnostic performance of CT and PCT and their combination in the differential diagnosis between active and inactive MTC and between MTC and non-MTC thyroid diseases, respectively.

METHODS

Serum samples were collected from 16 patients with active (i.e. primary tumour before surgery or post-surgical recurrent disease) and 23 with inactive (i.e. complete remission) MTC, 125 patients with non-MTC benign thyroid disease and 62 patients with non-MTC thyroid cancers, respectively. Elecsys CT and PCT measurements were simultaneously performed on the Cobas e601 platform (Roche Diagnostics, Rotkreutz, Switzerland).

RESULTS

Both CT and PCT median values in active MTC (94 pmol/L and 1.17 ng/mL, respectively) were significantly higher compared with inactive MTC (0.28 and 0.06) and either benign (0.37 and 0.06) or malignant (0.28 and 0.06) non-MTC. Undetectable PCT was found in five non-MTC patients with false positive CT results.

CONCLUSIONS

Elecsys PCT assay is a highly sensitive and specific alternative MTC marker. At the very least it appears useful in patients with positive CT results as negative PCT values securely exclude active MTC. The availability of both markers on the same automated platform facilitates reflex or reflective strategies to refine the laboratory diagnosis.

摘要

目的

髓样甲状腺癌 (MTC) 是由甲状腺滤泡旁 C 细胞的恶性转化引起的,降钙素 (CT) 在此释放。如今,CT 是用于诊断和随访 MTC 患者的主要肿瘤标志物。然而,降钙素原 (PCT) 最近被提议作为 MTC 的一种有用的辅助/替代生物标志物。我们的目的是分别研究 CT 和 PCT 及其组合在鉴别活跃性和非活跃性 MTC 以及 MTC 和非 MTC 甲状腺疾病方面的诊断性能。

方法

分别收集了 16 例活动性(即手术前原发性肿瘤或手术后复发疾病)和 23 例非活动性(即完全缓解)MTC、125 例非 MTC 良性甲状腺疾病和 62 例非 MTC 甲状腺癌患者的血清样本。同时在 Cobas e601 平台(罗氏诊断公司,罗特克里茨,瑞士)上进行 Elecsys CT 和 PCT 测量。

结果

与非活跃性 MTC(分别为 0.28 和 0.06)以及良性(分别为 0.37 和 0.06)或恶性(分别为 0.28 和 0.06)非 MTC 相比,活动性 MTC 中 CT 和 PCT 的中位数(分别为 94 pmol/L 和 1.17 ng/mL)均显著升高。在 5 例 CT 结果阳性而 PCT 结果不可检测的非 MTC 患者中。

结论

Elecsys PCT 检测法是一种高度敏感和特异的 MTC 替代标志物。至少在 CT 结果阳性的患者中,它似乎很有用,因为 PCT 值阴性可明确排除活动性 MTC。两种标志物均可在同一自动平台上获得,有助于简化实验室诊断的反射或反思策略。

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