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dc.contributor.authorPichet Sampatanukulen_US
dc.contributor.authorBenjaporn Chaiwunen_US
dc.contributor.authorSansanee Wongwaisayawanen_US
dc.contributor.authorParvinee Suwanagoolen_US
dc.contributor.authorSongkhun Vinyuvaten_US
dc.contributor.authorAnant Karalaken_US
dc.contributor.authorNiphon Praditpholen_US
dc.contributor.authorPaisit Paueksakonen_US
dc.contributor.authorPreecha Ruangvejvorachaien_US
dc.contributor.authorAndrew S. Fielden_US
dc.contributor.authorPongsak Wannakrairoten_US
dc.description.abstractObjectives: To develop and verify a standardized protocol for HER2 immunohistochemical assays on invasive ductal carcinoma of the breast in Thailand. Material and Method: A two-phase study approach was employed. In the Phase One, after verifying the proposed protocol that adopted the HercepTest procedure using readily available primary antibodies, CB11 and A0485, Lab 1 performed the HER2 immunohistochemical staining for 137 cases of invasive ductal carcinoma twice with two types of the antibody. Nine pathologists from 8 centers independently examined and scored all the 2x137 stained slides that were blinded for antibody type. Interobserver reliability was calculated using pair-wise kappa. Following discussion of the results, the Phase Two study was planned. Lab 2 and Lab 3 independently performed the HER2 staining according to the protocol for 60 invasive breast carcinoma cases. The same group of pathologists scored 2x60 stained slides that were masked for laboratories. Interobserver reliability and interlaboratory agreement from each pathologist were calculated using kappa statistics. Three interpreted categories - namely negative, equivocal and positive tests were used in the analyses. Results: Phase One study showed interobserver agreement between pairs varied from kappa 0.75 (95%CI, 0.68-0.82) to 0.06 (95%CI, 0-0.14) while Phase Two study obtained pair-wise kappa scores ranged from 0.84 (95%CI, 0.80-0.89) to 0.65 (95%CI, 0.59-0.71). Interlaboratory kappa for each pathologist was 0.67 (95%CI, 0.61-0.73). Conclusion: The standardization of HER2 immunohistochemical assay was achieved through this two-phase study model. It had added benefits of improving pathologists' expertise and verifying the HER2 testing protocol to be used in Thailand.en_US
dc.titleA two-phase study model for the standardization of HER2 immunohistochemical assay on invasive ductal carcinoma of the breasten_US
article.title.sourcetitleJournal of the Medical Association of Thailanden_US
article.volume88en_US Universityen_US Mai Universityen_US Universityen_US of Publicen_US Cancer Instituteen_US Hospitalen_US College of Medicineen_US Vincent's Hospital Sydneyen_US
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