Comparison of Dako HercepTest and Ventana PATHWAY Anti-HER2 (4B5) Tests and Their Correlation With Fluorescent In Situ Hybridization in Breast Carcinoma
| Autor: | Seema B. Jabbar, Xian Jin Xie, Yisheng V. Fang, Sunati Sahoo, Elena Lucas, Sara Blacketer, Kyle Molberg |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Pathology medicine.medical_specialty Histology Receptor ErbB-2 Breast Neoplasms In situ hybridization HercepTest Sensitivity and Specificity Pathology and Forensic Medicine 03 medical and health sciences 0302 clinical medicine Invasive breast carcinoma medicine Biomarkers Tumor Humans skin and connective tissue diseases In Situ Hybridization Fluorescence Observer Variation business.industry United States Food and Drug Administration Gene Amplification Antibodies Monoclonal Reproducibility of Results Immunohistochemistry United States Medical Laboratory Technology 030104 developmental biology 030220 oncology & carcinogenesis Female Anti her2 Observer variation Breast carcinoma business |
| Zdroj: | Applied immunohistochemistrymolecular morphology : AIMM. 27(6) |
| ISSN: | 1533-4058 |
| Popis: | We compared the performance of two Food and Drug Administration-approved HER2 immunohistochemistry (IHC) tests: HercepTest (Dako) and PATHWAY anti-HER2 (4B5) (Ventana).In total, 180 invasive breast carcinomas previously tested by both HercepTest and fluorescent in situ hybridization (FISH) were retested with 4B5. Three pathologists scored the HER2 IHC using the 2013 American Society of Clinical Oncology/College of American Pathologists guidelines. The HER2 IHC results were correlated with FISH.Among 135 equivocal cases by HercepTest, 100 (74.1%) were negative by 4B5. Among 45 positive HercepTest cases 9 (20%) were equivocal by 4B5. Among 135 equivocal HercepTest results, 100 (74.1%) were nonamplified, 18 (13.3%) equivocal, and 17 (12.6%) amplified by FISH. Among the 45 positive results with HercepTest, 2 (4.5%) were nonamplified and 1 (2.2%) was equivocal by FISH. All 37 positive and 3 negative by 4B5 cases were amplified by FISH. The absolute interobserver agreement was high for both tests (Fleiss kappa=0.838 for HercepTest and 0.771 for 4B5).PATHWAY anti-HER2 (4B5) significantly reduced the number of equivocal results that require additional testing. Although HercepTest was positive in a small number of HER2 nonamplified cases, 4B5 failed to detect 3 cases that were interpreted as positive by FISH, all with nonclassic or low levels of amplification. |
| Databáze: | OpenAIRE |
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