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Belgian recommendations for analytical verification and validation of immunohistochemical tests in laboratories of anatomic pathology

equipment are common practice for today’s anatomic pathology laboratories. Few references or guidelines are available on how this should be performed. The study of Sciensano (the Belgian national competent ...

The GEONs API-fingerprint program: Tackling falsifications of APIs

manufacturer and/or to data of fingerprint studies performed in the past. (Deconinck et al., 2022, Rebiere et al., 2022). The aim of the paper is to highlight the challenges and pitfalls in detecting falsified ...

Directive Pratique pour la mise en place d'un système qualité dans les laboratoires d'anatomie pathologique agréés dans le cadre de l'Arrêté d'agrément

performances analytiques. L’article 5.5 de l’ IVDR stipule qu’un test non CE- IVD ne peut être utilisé (et fabriqué à un niveau non-industriel) que lorsqu’un test CE- IVD équivalent disponible sur le marché ne satisfait pas ...

Deepening of In Silico Evaluation of SARS-CoV-2 Detection RT-qPCR Assays in the Context of New Variants

COVID-19 diagnosis is the detection of viral RNA by RT-qPCR with a specific set of primers and probe. It is important to frequently evaluate the performance of these tests and this can be done first by an in ...

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