Belgian recommendations for analytical verification and validation of immunohistochemical tests

Last updated on 20-1-2025 by Hannelien Verbeke

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Published

Scientific poster, presentation or proceeding

English

SCIENSANO

Abstract:

Validation of medical tests in laboratories is important prior to implementation of the test in daily routine to guarantee the quality and reliability of the patient results. But there are two problems: (i) There exist guidelines on validation of immunohistochemical biomarker assays but specific details regarding its application in individual laboratories of anatomic pathology are lacking. (ii) The European IVDR categorizes tests into CE-IVD tests and Laboratory developed tests (LDT) but does not contain a definition on modifications of CE-IVD tests resulting in LDTs and lacks informatio…

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