目的:在这个概念验证研究中,我们提出了一种自动数字定量PRAME(MELanoma的PReferential表达抗原)的新方法,作为区分良性和恶性黑素细胞病变的诊断辅助手段。所提出的方法利用PRAME和SOX10的免疫组织化学虚拟双核染色来精确识别感兴趣的黑素细胞,结合数字图像分析来量化PRAME指数。
方法:我们的研究包括10个复合痣,3光环痣,和10个黑色素瘤。组织载玻片用PRAME染色,扫描,移除了玻璃盖,用SOX10染色,再次扫描,最后进行了数字化分析。将数字量化的PRAME指数与皮肤病理学家使用标准PRAME评分系统进行的手动定性评估进行比较。
结果:数字量化的PRAME指数显示,将黑素瘤与良性病变分离的敏感性为70%,特异性为100%。手动定性PRAME评分显示60%的灵敏度和100%的特异性。使用ROC分析比较两种方法,我们的数字定量方法(AUC:0.931,95%CI:0.834;1.00,SD:0.050)与手动定性方法(AUC:0.877,95%CI:0.725;1.00,SD:0.078)保持一致.
结论:我们发现我们新的数字定量方法在将病变分类为良性或恶性方面至少与目前手动定性评估一样精确。我们的方法具有独立于操作员的优点,目标,和可复制的。此外,我们的方法可以很容易地在已经数字化的病理学部门实施。鉴于队列规模较小,我们还需要做更多的研究来验证我们的发现.
OBJECTIVE: In this proof-of-concept study, we propose a new method for automated digital quantification of PRAME (PReferentially expressed Antigen of MElanoma) as a diagnostic aid to distinguish between benign and malignant melanocytic lesions. The proposed method utilizes immunohistochemical virtual double nuclear staining for PRAME and SOX10 to precisely identify the melanocytic cells of interest, which is combined with digital image analyse to quantify a PRAME-index.
METHODS: Our study included 10 compound nevi, 3 halo nevi, and 10 melanomas. Tissue slides were stained with PRAME, scanned, the cover glass removed, stained with SOX10, scanned again, and finally analysed digitally. The digitally quantified PRAME-index was compared with a manual qualitative assessment by a dermatopathologist using the standard PRAME-scoring system.
RESULTS: The digitally quantified PRAME-index showed a sensitivity of 70 % and a specificity of 100 % for separating melanomas from benign lesions. The manual qualitative PRAME-score showed a sensitivity of 60 % and a specificity of 100 %. Comparing the two methods using ROC-analyses, our digital quantitative method (AUC: 0.931, 95 % CI: 0.834;1.00, SD: 0.050) remains on par with the manual qualitative method (AUC: 0.877, 95 % CI: 0.725;1.00, SD: 0.078).
CONCLUSIONS: We found our novel digital quantitative method was at least as precise at classifying lesions as benign or malignant as the current manual qualitative assessment. Our method has the advantages of being operator-independent, objective, and replicable. Furthermore, our method can easily be implemented in an already digitalized pathology department. Given the small cohort size, more studies are to be done to validate our findings.