Fitzgibbons Patrick L, Murphy Douglas A, Dorfman David M, Roche Patrick C, Tubbs Raymond R
Department of Pathology, St Jude Medical Center, Fullerton, Calif, USA.
Arch Pathol Lab Med. 2006 Oct;130(10):1440-5. doi: 10.5858/2006-130-1440-ICOITF.
Correct assessment of human epidermal growth factor receptor 2 (HER2) status is essential in managing patients with invasive breast carcinoma, but few data are available on the accuracy of laboratories performing HER2 testing by immunohistochemistry (IHC).
To review the results of the 2004 and 2005 College of American Pathologists HER2 Immunohistochemistry Tissue Microarray Survey.
The HER2 survey is designed for laboratories performing immunohistochemical staining and interpretation for HER2. The survey uses tissue microarrays, each consisting of ten 3-mm tissue cores obtained from different invasive breast carcinomas. All cases are also analyzed by fluorescence in situ hybridization. Participants receive 8 tissue microarrays (80 cases) with instructions to perform immunostaining for HER2 using the laboratory's standard procedures. The laboratory interprets the stained slides and returns results to the College of American Pathologists for analysis. In 2004 and 2005, a core was considered "graded" when at least 90% of laboratories agreed on the result--negative (0, 1+) versus positive (2+, 3+). This interlaboratory comparison survey included 102 laboratories in 2004 and 141 laboratories in 2005.
Of the 160 cases in both surveys, 111 (69%) achieved 90% consensus (graded). All 43 graded cores scored as IHC-positive were fluorescence in situ hybridization-positive, whereas all but 3 of the 68 IHC-negative graded cores were fluorescence in situ hybridization-negative. Ninety-seven (95%) of 102 laboratories in 2004 and 129 (91%) of 141 laboratories in 2005 correctly scored at least 90% of the graded cores.
Performance among laboratories performing HER2 IHC in this tissue microarray-based survey was excellent. Cores found to be IHC-positive or IHC-negative by participant consensus can be used as validated benchmarks for interlaboratory comparison, allowing laboratories to assess their performance and determine if improvements are needed.
准确评估人表皮生长因子受体2（HER2）状态对于浸润性乳腺癌患者的管理至关重要，但关于通过免疫组织化学（IHC）进行HER2检测的实验室准确性的数据很少。
回顾2004年和2005年美国病理学家学会HER2免疫组织化学组织微阵列调查的结果。
HER2调查是为进行HER2免疫组织化学染色和解读的实验室设计的。该调查使用组织微阵列，每个微阵列由从不同浸润性乳腺癌中获取的10个3毫米组织芯组成。所有病例也通过荧光原位杂交进行分析。参与者收到8个组织微阵列（80个病例），并按照实验室的标准程序对HER2进行免疫染色的指示。实验室对染色玻片进行解读，并将结果返回给美国病理学家学会进行分析。在2004年和2005年，当至少90%的实验室对结果达成一致（阴性[0、1+]与阳性[2+、3+]）时，一个组织芯被视为“已分级”。这项实验室间比较调查在2004年包括102个实验室，在2005年包括141个实验室。
在两项调查的160个病例中，111个（69%）达成了90%的共识（已分级）。所有43个被评为免疫组织化学阳性的分级组织芯在荧光原位杂交中均为阳性，而68个免疫组织化学阴性分级组织芯中除3个外，其余在荧光原位杂交中均为阴性。2004年102个实验室中的97个（95%）和2005年141个实验室中的129个（91%）对至少90%的分级组织芯进行了正确评分。
在这项基于组织微阵列的调查中，进行HER2免疫组织化学检测的实验室表现出色。通过参与者共识确定为免疫组织化学阳性或阴性的组织芯可作为实验室间比较的有效基准，使实验室能够评估其表现并确定是否需要改进。
