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8 results on '"Jacobs, L.H.J."'

1. Incidence of Interval Colorectal Cancer After Negative Results From First-Round Fecal Immunochemical Screening Tests, by Cutoff Value and Participant Sex and Age

Author

van der Beek, A., Otte, J.A., Wiersma, Tj., Masclee, A.A.M., van Bergeijk, J., Meijer, G., de Graaf, E.J.R., van Grevenstein, W.M.U., Frasa, M., Jacobs, L.H.J., Stoker, J., Vink, G., Elferink, M.A., Toes-Zoutendijk, Esther, Kooyker, Arthur I., Dekker, Evelien, Spaander, Manon C.W., Opstal-van Winden, Annemieke W.J., Ramakers, Christian, Buskermolen, Maaike, van Vuuren, Anneke J., Kuipers, Ernst J., van Kemenade, Folkert J., Velthuysen, Marie-Louise F., Thomeer, Maarten G.J., van Veldhuizen, Harriët, van Ballegooijen, Marjolein, Nagtegaal, Iris D., de Koning, Harry J., van Leerdam, Monique E., and Lansdorp-Vogelaar, Iris

Published
2020
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2. ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation.

Author

Vanstapel, F.J.L.A., Orth, M., Streichert, T., Capoluongo, E.D., Oosterhuis, W.P., Çubukçu, H.C., Bernabeu-Andreu, F.A., Thelen, M.H.M., Jacobs, L.H.J., Linko, S., Bhattoa, H.P., Bossuyt, P.M., Meško Brguljan, P., Boursier, G., Cobbaert, C.M., Neumaier, M., Vanstapel, F.J.L.A., Orth, M., Streichert, T., Capoluongo, E.D., Oosterhuis, W.P., Çubukçu, H.C., Bernabeu-Andreu, F.A., Thelen, M.H.M., Jacobs, L.H.J., Linko, S., Bhattoa, H.P., Bossuyt, P.M., Meško Brguljan, P., Boursier, G., Cobbaert, C.M., and Neumaier, M.

Abstract

Item does not contain fulltext, The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely identified devices, and post-market surveillance. The IVDR regulates design, manufacture and putting into use of devices, but not medical services using these devices. In the absence of suitable commercial devices, the laboratory can resort to laboratory-developed tests (LDT) for in-house use. Documentary obligations (IVDR Art 5.5), the performance and safety specifications of ANNEX I, and development and manufacture under an ISO 15189-equivalent quality system apply. LDTs serve specific clinical needs, often for low volume niche applications, or correspond to the translational phase of new tests and treatments, often extremely relevant for patient care. As some commercial tests may disappear with the IVDR roll-out, many will require urgent LDT replacement. The workload will also depend on which modifications to commercial tests turns them into an LDT, and on how national legislators and competent authorities (CA) will handle new competences and responsibilities. We discuss appropriate interpretation of ISO 15189 to cover IVDR requirements. Selected cases illustrate LDT implementation covering medical needs with commensurate management of risk emanating from intended use and/or design of devices. Unintended collateral damage of the IVDR comprises loss of non-profitable niche applications, increases of costs and wasted resources, and migration of innovative research to more cost-efficient environments. Taking into account local specifics, the legislative framework should reduce the burden on and associated opportunity costs for the health care system, by making diligent use of existing frameworks.

Published
2023

3. The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications

Author

Bank, P.C.D., Jacobs, L.H.J., Berg, S.A.A. van den, Deutekom, H.W.M. van, Hamann, D., Molenkamp, R., Ruivenkamp, C.A.L., Swen, J.J., Tops, B.B.J., Wamelink, M.M.C., Wessels, E., and Oosterhuis, W.P.

Subjects
laboratory medicine, laboratory developed test, quality assessment, diagnostic test approval, diagnostic medical devices regulation (IVDR), implementation, legislation, medical device legislation
Abstract

The in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantlywewould like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.

Published
2021

4. Incidence of Interval Colorectal Cancer After Negative Results From First-Round Fecal Immunochemical Screening Tests, by Cutoff Value and Participant Sex and Age

Author

Toes-Zoutendijk, E. (Esther), Kooyker, A.I. (Arthur), Dekker, E. (Evelien), Spaander, M.C.W. (Manon), Opstal-Van Winden, A. (Annemieke), Ramakers, C.R.B., Buskermolen, M. (Maaike), Vuuren, A.J. (Hanneke) van, Kuipers, E.J. (Ernst), Kemenade, F.J. (Folkert) van, Velthuysen, M.-L.F. (Marie-Louise F.), Thomeer, M.G.J. (Maarten), Van Veldhuizen, H. (Harriët), Ballegooijen, M. (Marjolein) van, Nagtegaal, I.D. (Iris), Koning, H.J. (Harry) de, Leerdam, M.E. (Monique) van, Lansdorp-Vogelaar, I. (Iris), Beek, A.J. (Allard) van der, Otte, J.A. (J. A.), Wiersma, T. (Tj.), Masclée, A.A.M. (Ad), Bergeijk, J.D. (Jeroen) van, Meijer, C.J.L.M. (Chris), Graaf, E.J.R. (Eelco) de, Grevenstein, H.M.U. (Helma) van, Frasa, M. (M.), Jacobs, L.H.J. (L. H.J.), Stoker, J. (Jacob), Vink, G. (G.), Elferink, M.A.G. (Marloes), Toes-Zoutendijk, E. (Esther), Kooyker, A.I. (Arthur), Dekker, E. (Evelien), Spaander, M.C.W. (Manon), Opstal-Van Winden, A. (Annemieke), Ramakers, C.R.B., Buskermolen, M. (Maaike), Vuuren, A.J. (Hanneke) van, Kuipers, E.J. (Ernst), Kemenade, F.J. (Folkert) van, Velthuysen, M.-L.F. (Marie-Louise F.), Thomeer, M.G.J. (Maarten), Van Veldhuizen, H. (Harriët), Ballegooijen, M. (Marjolein) van, Nagtegaal, I.D. (Iris), Koning, H.J. (Harry) de, Leerdam, M.E. (Monique) van, Lansdorp-Vogelaar, I. (Iris), Beek, A.J. (Allard) van der, Otte, J.A. (J. A.), Wiersma, T. (Tj.), Masclée, A.A.M. (Ad), Bergeijk, J.D. (Jeroen) van, Meijer, C.J.L.M. (Chris), Graaf, E.J.R. (Eelco) de, Grevenstein, H.M.U. (Helma) van, Frasa, M. (M.), Jacobs, L.H.J. (L. H.J.), Stoker, J. (Jacob), Vink, G. (G.), and Elferink, M.A.G. (Marloes)

Abstract

Background & Aims: We evaluated the incidence of interval cancers between the first and second rounds of colorectal cancer (CRC) screening with the FOB-Gold fecal immunochemical test (FIT), and the effects of different cutoff values and patient sex and age. Methods: We collected data from participants in a population-based C

Published
2020
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5. Incidence of Interval Colorectal Cancer After Negative Results From First-Round Fecal Immunochemical Screening Tests, by Cutoff Value and Participant Sex and Age

Author

Toes-Zoutendijk, Esther, primary, Kooyker, Arthur I., additional, Dekker, Evelien, additional, Spaander, Manon C.W., additional, Opstal-van Winden, Annemieke W.J., additional, Ramakers, Christian, additional, Buskermolen, Maaike, additional, van Vuuren, Anneke J., additional, Kuipers, Ernst J., additional, van Kemenade, Folkert J., additional, Velthuysen, Marie-Louise F., additional, Thomeer, Maarten G.J., additional, van Veldhuizen, Harriët, additional, van Ballegooijen, Marjolein, additional, Nagtegaal, Iris D., additional, de Koning, Harry J., additional, van Leerdam, Monique E., additional, Lansdorp-Vogelaar, Iris, additional, van der Beek, A., additional, Otte, J.A., additional, Wiersma, Tj., additional, Masclee, A.A.M., additional, van Bergeijk, J., additional, Meijer, G., additional, de Graaf, E.J.R., additional, van Grevenstein, W.M.U., additional, Frasa, M., additional, Jacobs, L.H.J., additional, Stoker, J., additional, Vink, G., additional, and Elferink, M.A., additional

Published
2020
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