Essentials for verifying test performance - accreditation preparedness (SCQ02) PDF Download
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Languages : en
Pages :
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Author:
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ISBN:
Category :
Languages : en
Pages :
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Author: Christopher M. Lehman
Publisher:
ISBN: 9781562388515
Category :
Languages : en
Pages : 63
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Author: Jan S. Krouwer
Publisher:
ISBN:
Category :
Languages : en
Pages : 39
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Author: Gary L. Horowitz
Publisher:
ISBN: 9781562386825
Category : Diagnosis, Laboratory
Languages : en
Pages : 61
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Author: Clsi
Publisher:
ISBN: 9781562387457
Category : Medical
Languages : en
Pages : 139
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Book Description
Immunohistochemistry is an analytical technique that applies an antibody reagent to detect and visualize an antigen in cytological and surgical pathology microscopy specimens in the context of histomorphology and cytomorphology. The clinical-pathological interpretation of the presence and patterns of the antibody-antigen reactions is performed in a manner similar to other molecular pathology assays. Immunohistochemistry is used in diagnostic pathology for diagnosis, determination of prognosis, and predictive assays for response to therapy. Accurate and reproducible results require quality assurance of the total test system including the design control of the reagents and the preexamination (preanalytical), examination (analytical), and postexamination (postanalytical) interpretation steps (processes) of the assay to ensure its clinical applicability. This guideline focuses on validation of immunohistochemistry assays on formalin-fixed, paraffin-embedded pathology material. The audience for this guideline includes the assay developer, the reagent supplier, laboratory histotechnologist who performs the assay, and the laboratory director/pathologist who implements and interprets the assay.
Author: R. Neill Carey
Publisher:
ISBN: 9781562385743
Category : Clinical chemistry
Languages : en
Pages : 51
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Author: R. Neill Carey
Publisher:
ISBN: 9781562384517
Category :
Languages : en
Pages : 48
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Author: Clsi
Publisher: NCCLC
ISBN: 9781562386139
Category :
Languages : en
Pages : 33
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Book Description
This document provides definitions of analytical intervals, planning of quality control procedures, and guidance for quality control applications.
