确定西门子 Atellica 降钙素测定的功能敏感性:单中心研究的启示

IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Endocrine Practice Pub Date : 2024-11-01 DOI:10.1016/j.eprac.2024.08.007
Jieli Li MD, PhD , Ashley Patton MD , Jason K.Y. Lee MLSMS , Matt Scheidegger MT , Irina Azaryan MD , Jennifer A. Sipos MD , Fadi Nabhan MD , JoAnna Jones MD , Alicia Algeciras-Schimnich PhD , Matthew D. Ringel MD
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引用次数: 0

摘要

背景:根据美国甲状腺协会(ATA)指南,甲状腺切除术后血清降钙素原和癌胚抗原(CEA)水平可检测到,尤其是不断升高,表明可能存在疾病,需要经常测量降钙素原或进行成像检查,以早期发现持续性或复发性甲状腺髓样癌(MTC)。因此,根据影像学和临床状况确定降钙素检测的临床临界值对患者护理至关重要。本研究旨在使用新型西门子 Atellica 检测系统评估术后降钙素水平,以确定最适合临床决策的水平:在 2022 年 9 月 27 日至 2023 年 11 月 8 日期间,使用西门子 Atellica 对 40 名患者的 56 份样本进行了降钙素检测,并进行了回顾性分析。仅纳入了甲状腺全切除术后至少 3 个月的降钙素结果。对降钙素报告后 6 个月内的影像学研究进行了评估。同时还审查了 CEA 结果:精度分析显示,2.94 和 5.24 pg/mL 的变异系数(CV)分别为 16.49% 和 8.87%。对于经影像学证实的甲状腺全切除术后顽固性或复发性 MTC 证据,使用 1.89 pg/mL 的降钙素临界值可获得 43% 的灵敏度和 67% 的特异性。使用 5.00 pg/mL 临界值的敏感性为 0%,特异性为 100%:我们的研究结果表明,西门子 Atellica 平台上的 5 pg/mL 降钙素截止值可能适用于评估本机构甲状腺切除术后患者的肿瘤持续存在或复发情况。不过,各实验室在评估降钙素水平以监测甲状腺切除术后肿瘤复发时,应确定自己的临床临界值。
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Defining the Functional Sensitivity for the Siemens Atellica Calcitonin Assay: Insight From a Single-Center Study

Background

Detectable, and especially rising postthyroidectomy serum calcitonin and carcinoembryonic antigen levels, as per American Thyroid Association guidelines, indicate potential disease presence, requiring frequent calcitonin measurement or imaging for early detection of persistent or recurrent medullary thyroid carcinoma. Thus, defining the clinical cutoff value of detection of calcitonin assays relative to imaging and clinical status is crucial for patient care. This study aimed to evaluate postoperative calcitonin levels using the new Siemens Atellica assay system to determine the most appropriate levels for clinical decision-making.

Methods

A retrospective analysis was conducted using Siemens Atellica for calcitonin testing on 56 samples from 40 patients between September 27, 2022 and August 11, 2023. Only calcitonin results performed at least 3 months post-total thyroidectomy were included. Imaging studies, within 6 months of the calcitonin report, were assessed. Carcinoembryonic antigen results were also reviewed.

Results

Precision analysis at 2.94 and 5.24 pg/mL revealed coefficients of variation at 16.49% and 8.87%, respectively. For the evidence of post-total thyroidectomy persistent or recurrent medullary thyroid carcinoma confirmed by imaging, using a 1.89 pg/mL cutoff for calcitonin yielded 43% sensitivity and 67% specificity. Using a 5.00 pg/mL cutoff resulted in 0% sensitivity and 100% specificity.

Conclusions

Our findings indicate the potential suitability of a 5 pg/mL calcitonin cutoff on the Siemens Atellica platform for evaluating tumor persistence or recurrence in post-thyroidectomy patients in our institution. However, individual laboratories should establish their own clinical cutoff value when evaluating calcitonin levels for monitoring tumor recurrence post-thyroidectomy.
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来源期刊
Endocrine Practice
Endocrine Practice ENDOCRINOLOGY & METABOLISM-
CiteScore
7.60
自引率
2.40%
发文量
546
审稿时长
41 days
期刊介绍: Endocrine Practice (ISSN: 1530-891X), a peer-reviewed journal published twelve times a year, is the official journal of the American Association of Clinical Endocrinologists (AACE). The primary mission of Endocrine Practice is to enhance the health care of patients with endocrine diseases through continuing education of practicing endocrinologists.
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