PMID- 22261453 OWN - NLM STAT- MEDLINE DCOM- 20120306 LR - 20191210 IS - 1943-7722 (Electronic) IS - 0002-9173 (Linking) VI - 137 IP - 2 DP - 2012 Feb TI - Image analysis of HER2 immunohistochemical staining. Reproducibility and concordance with fluorescence in situ hybridization of a laboratory-validated scoring technique. PG - 270-6 LID - 10.1309/AJCP9MKNLHQNK2ZX [doi] AB - Image analysis of the HER2 immunohistochemical (IHC) stain can help determine which breast cancer patients may benefit from HER2-targeted therapy. We studied the concordance of HER2 IHC and fluorescence in situ hybridization (FISH) as well as reproducibility of surgical pathologist (SP) and cytotechnologist (CT) interpretations using manual and image analysis methodologies on 154 IHC cases. Concordances with FISH were good for IHC negative (0, 1+) cases (range, 97%-100%) and positive (3+) cases (range, 87%-100%). Image analysis had fewer equivocal (2+) results (10.4%) than CT (14.9%) and SP (16.2%) manual methods, with higher concordances to FISH (31%, 26%, and 20% for image analysis, CT manual, and SP manual, respectively). CT manual (kappa = 0.747) and image analysis (kappa = 0.779) methods had better interobserver reproducibility than SP manual (kappa = 0.697). CT image analysis had better intraobserver reproducibility (kappa = 0.882) than CT (kappa = 0.828) and SP (kappa = 0.766) manual methods. HER2 IHC analysis performed by image analysis can produce accurate results with improved reproducibility. FAU - Minot, Douglas M AU - Minot DM AD - Dept. of Laboratory Medicine and Pathology, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA. FAU - Voss, Jesse AU - Voss J FAU - Rademacher, Susan AU - Rademacher S FAU - Lwin, Toe AU - Lwin T FAU - Orsulak, Jessica AU - Orsulak J FAU - Caron, Bolette AU - Caron B FAU - Ketterling, Rhett AU - Ketterling R FAU - Nassar, Aziza AU - Nassar A FAU - Chen, Beiyun AU - Chen B FAU - Clayton, Amy AU - Clayton A LA - eng PT - Comparative Study PT - Journal Article PT - Validation Study PL - England TA - Am J Clin Pathol JT - American journal of clinical pathology JID - 0370470 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antineoplastic Agents) RN - 0 (DNA, Neoplasm) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P188ANX8CK (Trastuzumab) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal, Humanized/therapeutic use MH - Antineoplastic Agents/therapeutic use MH - Breast Neoplasms/*diagnosis/drug therapy/genetics/metabolism MH - DNA, Neoplasm/analysis MH - Female MH - Humans MH - Image Processing, Computer-Assisted/*methods/standards MH - In Situ Hybridization, Fluorescence MH - Middle Aged MH - Observer Variation MH - Receptor, ErbB-2/*genetics/*metabolism MH - Reproducibility of Results MH - Retrospective Studies MH - Trastuzumab MH - Young Adult EDAT- 2012/01/21 06:00 MHDA- 2012/03/07 06:00 CRDT- 2012/01/21 06:00 PHST- 2012/01/21 06:00 [entrez] PHST- 2012/01/21 06:00 [pubmed] PHST- 2012/03/07 06:00 [medline] AID - 137/2/270 [pii] AID - 10.1309/AJCP9MKNLHQNK2ZX [doi] PST - ppublish SO - Am J Clin Pathol. 2012 Feb;137(2):270-6. doi: 10.1309/AJCP9MKNLHQNK2ZX.