Nunes C B, Rocha R M, Reis-Filho J S, Lambros M B, Rocha G F S, Sanches F S F, Oliveira F N, Gobbi H
Department of Anatomic Pathology, Federal University of Minas Gerais, Belo Horizonte, Brazil.
J Clin Pathol. 2008 Aug;61(8):934-8. doi: 10.1136/jcp.2007.053892. Epub 2008 May 12.
To compare the sensitivity and specificity of new rabbit monoclonal antibody SP3 with those of mouse monoclonal and rabbit polyclonal antibodies using HER2 amplification defined by chromogenic in situ hybridisation (CISH) as the gold standard.
Serial sections from tissue microarrays (TMAs) containing 84 breast carcinomas were submitted to CISH (Zymed HER2 Spot-Light kit) and immunohistochemistry, using NeoMarkers SP3 (rabbit monoclonal), DAKO A0485 and DAKO HercepTest (polyclonal), Novocastra NCL-CB11, Cell Marque CM-CB11, and Genentech 4D5 (mouse monoclonal).
The best antibody concordance was between SP3 and HercepTest (kappa = 0.74). SP3, A0485 and HercepTest detected all HER2 amplified tumours, but were less specific than mouse monoclonal antibodies. 3/38 (7.9%) and 8/38 (21.0%) non-amplified tumours were scored as 3+ using SP3 and A0485, respectively. 3/46 (6.5%) amplified tumours were negative for NCL-CB11. SP3, HercepTest and A0485 showed no gene amplification on 55%, 62.5% and 92.3% of the 2+ scored tumours, but most of the 2+ scored tumours using monoclonal antibodies were amplified by CISH (80-92.3%).
SP3 is more sensitive than mouse monoclonal antibodies for Her2 assessment. However, HercepTest, CB11 and 4D5 show higher specificity than SP3 for the identification of HER2 gene amplification. Mouse monoclonal antibodies show less Her2 2+ tumours; most are amplified by CISH.
以显色原位杂交（CISH）定义的HER2扩增为金标准，比较新型兔单克隆抗体SP3与小鼠单克隆抗体和兔多克隆抗体的敏感性和特异性。
对包含84例乳腺癌的组织微阵列（TMA）连续切片进行CISH（Zymed HER2 Spot-Light试剂盒）和免疫组织化学检测，使用NeoMarkers SP3（兔单克隆抗体）、DAKO A0485和DAKO HercepTest（多克隆抗体）、Novocastra NCL-CB11、Cell Marque CM-CB11以及基因泰克4D5（小鼠单克隆抗体）。
SP3与HercepTest之间的抗体一致性最佳（kappa = 0.74）。SP3、A0485和HercepTest检测到所有HER2扩增肿瘤，但特异性低于小鼠单克隆抗体。分别有3/38（7.9%）和8/38（21.0%）的非扩增肿瘤使用SP3和A0485评分被判定为3+。3/46（6.5%）的扩增肿瘤NCL-CB11检测为阴性。SP3、HercepTest和A0485在2+评分肿瘤中分别有55%、62.5%和92.3%未显示基因扩增，但使用单克隆抗体评分2+的肿瘤多数经CISH检测为扩增（80 - 92.3%）。
在HER2评估中，SP3比小鼠单克隆抗体更敏感。然而，在识别HER2基因扩增方面，HercepTest、CB11和4D5比SP3具有更高的特异性。小鼠单克隆抗体检测到的Her2 2+肿瘤较少；多数经CISH检测为扩增。
