Supplemental Digital Content is available in the text. Introduction: This systematic review has the purpose to characterize the accuracy of chromogenic in situ hybridization (CISH) and silver in situ hybridization (SISH), in comparison to fluorescence in situ hybridization (FISH) in the identification of human epidermal growth factor receptor-2 (HER2) overexpression and to inform decisions about test selection. Materials and Methods: We searched MEDLINE and EMBASE databases using these eligibility criteria: studies evaluating invasive breast cancer samples which examined agreement between CISH or SISH, and FISH, and reported sensitivity, specificity, or concordance. We performed a bivariate meta-analysis of sensitivity and specificity using a generalized linear mixed model. We used likelihood ratio tests from meta-regression to compare accuracy between HER2 tests. Results: The search identified 4475 articles, of which 32 were included. The summary estimates for sensitivity and specificity were 0.91 [95% confidence interval (CI), 0.85-0.95], and 0.97 (95% CI, 0.93-0.99) for SISH; 0.97 (95% CI, 0.83-1.00) and 0.99 (95% CI, 0.96-1.00) for single-probe CISH; and, 0.98 (95% CI, 0.92-0.99) and 0.98 (95% CI, 0.91-0.99) for dual-probe CISH. Significantly higher sensitivity was reported for dual-CISH than SISH (χ2: 5.36; P=0.02) when compared with the reference test FISH. Conclusions: The agreement between new bright field tests (SISH and CISH) and FISH is high (≥92%). Indirect comparison of HER2 tests indicated that overall CISH performance exceeds that of SISH. The pooled estimates from this meta-analysis summarize the current published literature and, in addition to other factors such as costs differentials, can help inform future HER2 test selection decisions.

中文翻译：

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显色和银原位杂交用于鉴定乳腺癌患者中的 HER 2 过表达

补充数字内容在文本中可用。简介：本系统评价旨在表征显色原位杂交 (CISH) 和银原位杂交 (SISH) 与荧光原位杂交 (FISH) 在鉴定人表皮生长因子受体 2 中的准确性(HER2) 过表达并告知有关测试选择的决定。材料和方法：我们使用以下资格标准搜索了 MEDLINE 和 EMBASE 数据库：评估浸润性乳腺癌样本的研究，这些研究检查了 CISH 或 SISH 与 FISH 之间的一致性，并报告了敏感性、特异性或一致性。我们使用广义线性混合模型对敏感性和特异性进行了双变量荟萃分析。我们使用来自元回归的似然比测试来比较 HER2 测试之间的准确性。结果：搜索确定了 4475 篇文章，其中 32 篇被纳入。SISH 的敏感性和特异性的汇总估计值为 0.91 [95% 置信区间 (CI)，0.85-0.95] 和 0.97（95% CI，0.93-0.99）；单探针 CISH 为 0.97（95% CI，0.83-1.00）和 0.99（95% CI，0.96-1.00）；双探针 CISH 为 0.98（95% CI，0.92-0.99）和 0.98（95% CI，0.91-0.99）。与参考测试 FISH 相比，双 CISH 报告的灵敏度显着高于 SISH（χ2：5.36；P=0.02）。结论：新的明场试验（SISH 和 CISH）与 FISH 之间的一致性很高（≥92%）。HER2 测试的间接比较表明整体 CISH 性能超过了 SISH。