Chaudhary Shweta, Hou Yanjun, Shen Rulong, Hooda Shveta, Li Zaibo
Department of Pathology, Wexner Medical Center, Ohio State University, Columbus, Ohio, USA.
Acta Cytol. 2016;60(3):205-10. doi: 10.1159/000446797. Epub 2016 Jun 25.
The Afirma gene expression classifier (GEC) is a molecular test to further classify indeterminate fine-needle aspiration (FNA) as benign or suspicious for malignancy.
A total of 158 FNAs with Bethesda category III/IV cytology were sent for an Afirma GEC test. We correlated the Afirma GEC results with surgical outcome and also compared the data after Afirma's implementation with the data before.
Among the 158 FNAs, the Afirma result was benign in 63 (40%), suspicious in 85 (54%) and unsatisfactory in 10 (6%). In total, 73 (86%) suspicious Afirma cases had surgery and 28 (38%) showed carcinoma. In contrast, only 8 (13%) benign Afirma cases had surgery and all of them were benign. The sensitivity, specificity, negative predictive value and positive predictive value (PPV) of Afirma were 100, 15, 100 and 38%, respectively. The PPV was 20% in cases with follicular lesion of undetermined significance, but was 50% in cases suspicious for follicular neoplasm (SFN). The surgical excisional rate was significantly decreased in SFN cases after the Afirma test.
The Afirma GEC is useful for further risk stratifying SFN cases.
Afirma基因表达分类器（GEC）是一种分子检测方法，用于将不确定的细针穿刺活检（FNA）结果进一步分类为良性或恶性可疑。
共158例Bethesda分类为III/IV级的FNA样本被送去进行Afirma GEC检测。我们将Afirma GEC检测结果与手术结果进行关联，并比较了Afirma检测实施前后的数据。
在158例FNA样本中，Afirma检测结果为良性的有63例（40%），可疑的有85例（54%），不满意的有10例（6%）。总共有73例（86%）Afirma检测结果可疑的病例接受了手术，其中28例（38%）显示为癌。相比之下，只有8例（13%）Afirma检测结果为良性的病例接受了手术，且所有这些病例均为良性。Afirma检测的敏感性、特异性、阴性预测值和阳性预测值（PPV）分别为100%、15%、100%和38%。在意义未明的滤泡性病变病例中，PPV为20%，但在可疑滤泡性肿瘤（SFN）病例中为50%。Afirma检测后，SFN病例的手术切除率显著降低。
Afirma GEC有助于对SFN病例进行进一步的风险分层。
