Background/Objective: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has affected more than 1700 women with textured breast implants. About 80% of patients present with fluid (seroma) around their implant. BIA-ALCL can be cured by surgery alone when confined to the seroma and lining of the peri-implant capsule. To address the need for early detection, we developed a rapid point of care (POC) lateral flow assay (LFA) to identify lymphoma in seromas. Methods: We compared 28 malignant seromas to 23 benign seromas using both ELISA and LFA. LFA test lines (TL) and control lines (CL) were visualized and measured with imaging software and the TL/CL ratio for each sample was calculated. Results: By visual exam, the sensitivity for detection of CA9 was 93% and specificity 78%, while the positive predictive value was 84% and negative predictive value 90%. Quantitative image analysis increased the positive predictive value to 96% while the negative predictive value reduced to 79%. Conclusions: We conclude that CA9 is a sensitive biomarker for detection and screening of patients for BIA-ALCL in patients who present with seromas of unknown etiology. The CA9 LFA can potentially replace ELISA, flow cytometry and other tests requiring specialized equipment, highly trained personnel, larger amounts of fluid and delay in diagnosis of BIA-ALCL.
背景/目的：乳房假体相关的间变性大细胞淋巴瘤（BIA-ALCL）已影响超过1700名使用毛面乳房假体的女性。约80%的患者表现为假体周围积液（血清肿）。当BIA-ALCL局限于血清肿及假体周围包膜内衬时，仅通过手术即可治愈。为满足早期检测需求，我们开发了一种快速床旁侧向层析检测法，用于识别血清肿中的淋巴瘤。方法：我们采用酶联免疫吸附测定和侧向层析检测法，对28例恶性血清肿和23例良性血清肿进行了比较。通过成像软件对侧向层析检测的测试线和对照线进行可视化测量，并计算每个样本的测试线/对照线比值。结果：通过目视检查，CA9检测的敏感性为93%，特异性为78%，阳性预测值为84%，阴性预测值为90%。定量图像分析将阳性预测值提高至96%，而阴性预测值降至79%。结论：我们认为CA9是检测和筛查病因不明血清肿患者中BIA-ALCL的敏感生物标志物。CA9侧向层析检测法有望替代酶联免疫吸附测定、流式细胞术及其他需要专业设备、高技能人员、大量液体且会延迟BIA-ALCL诊断的检测方法。
肿瘤(癌症)患者之家