Analytical Validity of a MicroRNA-Based Assay for Diagnosing Indeterminate Thyroid FNA Smears From Routinely Prepared Cytology Slides
Analytical Validity of a MicroRNA-Based Assay for Diagnosing Indeterminate Thyroid FNA Smears From Routinely Prepared Cytology Slides
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DOI：
10.1002/cncy.21731
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发表时间：
2016-10-01
影响因子：
3.4
通讯作者：
Meiri, Eti
中科院分区：
文献类型：
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作者：
Benjamin, Hila;Schnitzer-Perlman, Temima;Meiri, Eti
背景：大多数甲状腺结节是通过细针穿刺（FNA）活检诊断的。作者最近描述了一种基于分子微rna的检测方法RosettaGX Reveal的临床验证，该方法可以通过单个染色的FNA涂片诊断甲状腺结节是良性还是可疑。本文描述了该方法的分析验证。方法：对800多张FNA载玻片进行检测，包括罗曼诺夫斯基型和帕帕尼科拉乌染色。检查了以下特征：结节内一致性、染色类型的影响、最小可接受RNA量、低数量甲状腺细胞的表现、采样后时间的影响、分析灵敏度、特异性和可重复性。结果：该实验可以在FNA载玻片上运行，其中只有1%的细胞是甲状腺上皮细胞，或者从中只提取了5ng的RNA。完全由血液组成的样本没有通过质量控制，没有分类。染色类型不影响性能。所有载玻片在室温下保存。然而，FNA取样和处理之间的时间长度不影响分析性能。实验室间的一致性很高（96%），同一FNA通道生成的载玻片的一致性为93%。结论：基于微rna的检测方法对各种物理处理条件和不同的样品特性都是可靠的。鉴于该检测的性能、稳健性和常规制备的FNA载玻片的使用，它有可能为医生诊断甲状腺结节提供有价值的帮助。(C) 2016年罗塞塔基因组公司。Wiley期刊公司代表美国癌症协会出版的《癌症细胞病理学》。
BACKGROUND: The majority of thyroid nodules are diagnosed using fine-needle aspiration (FNA) biopsies. The authors recently described the clinical validation of a molecular microRNA-based assay, RosettaGX Reveal, which can diagnose thyroid nodules as benign or suspicious using a single stained FNA smear. This paper describes the analytical validation of the assay. METHODS: More than 800 FNA slides were tested, including slides stained with Romanowsky-type and Papanicolaou stains. The assay was examined for the following features: intranodule concordance, effect of stain type, minimal acceptable RNA amounts, performance on low numbers of thyroid cells, effect of time since sampling, and analytical sensitivity, specificity, and reproducibility. RESULTS: The assay can be run on FNA slides for which as little as 1% of the cells are thyroid epithelial cells or from which only 5 ng of RNA have been extracted. Samples composed entirely of blood failed quality control and were not classified. Stain type did not affect performance. All slides were stored at room temperature. However, the length of time between FNA sampling and processing did not affect assay performance. There was a high level of concordance between laboratories (96%), and the concordance for slides created from the same FNA pass was 93%. CONCLUSIONS: The microRNA-based assay was robust to various physical processing conditions and to differing sample characteristics. Given the assay's performance, robustness, and use of routinely prepared FNA slides, it has the potential to provide valuable aid for physicians in the diagnosis of thyroid nodules. (C) 2016 Rosetta Genomics. Cancer Cytopathology published by Wiley Periodicals, Inc. on behalf of American Cancer Society.