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2. Medical microbiology laboratories in the Netherlands can detect animal type A influenza viruses well : External Quality Assessment 2023

Author

Zoomer, S., Goderski, G., Brink, S. van den, Sluimer, J., Fouchier, R., Vuong, O., Vries, E. van der, Houben, M., Meijer, A., Zoomer, S., Goderski, G., Brink, S. van den, Sluimer, J., Fouchier, R., Vuong, O., Vries, E. van der, Houben, M., and Meijer, A.

Abstract

Medisch microbiologische laboratoria in Nederland kunnen dierlijke type A griepvirussen goed aantonen. Kwaliteitscontrole 2023. Typen A en B griepvirussen kunnen ernstige ziekte bij mensen veroorzaken. Het type A griepvirus heeft veel subtypen en komt ook bij vogels en varkens voor. In Nederland testen de zogeheten ‘medisch microbiologische laboratoria’ of mensen besmet zijn met een griepvirus. Dat geeft inzicht in hoeveel mensen besmet zijn met een griepvirus en of het virus van type A of B is.

Published
2023

4. Corrigendum to ‘Performance of the Diasorin SARS-CoV-2 antigen detection assay on the LIAISON XL’ [Journal of Clinical Virology 141 (2021) 104909]

Author

Medische Microbiologie, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, MMB Staf diagnostiek, Sportgeneeskunde Onderwijs, Zorgeenheid Kinderchirurgie Medisch, MMB Medische Staf, Van der Moeren, N, Zwart, V F, Goderski, G, Rijkers, G T, van den Bijllaardt, W, Veenemans, J, Kluytmans, Jajw, Pas, S D, Meijer, A, Verweij, J J, Murk, Jlan, Stohr, Jjjm, Medische Microbiologie, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, MMB Staf diagnostiek, Sportgeneeskunde Onderwijs, Zorgeenheid Kinderchirurgie Medisch, MMB Medische Staf, Van der Moeren, N, Zwart, V F, Goderski, G, Rijkers, G T, van den Bijllaardt, W, Veenemans, J, Kluytmans, Jajw, Pas, S D, Meijer, A, Verweij, J J, Murk, Jlan, and Stohr, Jjjm

Published
2022

7. Performance of the Diasorin SARS-CoV-2 antigen detection assay on the LIAISON XL

Author

Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten Team 1, Van der Moeren, N., Zwart, V. F., Goderski, G., Rijkers, G. T., van den Bijllaardt, W., Veenemans, J., Kluytmans, J. A.J.W., Pas, S. D., Meijer, A., Verweij, J. J., Murk, J. L.A.N., Stohr, J. J.J.M., Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten Team 1, Van der Moeren, N., Zwart, V. F., Goderski, G., Rijkers, G. T., van den Bijllaardt, W., Veenemans, J., Kluytmans, J. A.J.W., Pas, S. D., Meijer, A., Verweij, J. J., Murk, J. L.A.N., and Stohr, J. J.J.M.

Published
2021

8. Multi-center evaluation of cepheid xpert(R) xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic

Author

Wolters, F., Bovenkamp, J. van de, Bosch, B. van den, Brink, S. van den, Broeders, M., Chung, N.H., Favie, B., Goderski, G., Kuijpers, J., Overdevest, I., Rahamat-Langendoen, J.C., Wijsman, L., Melchers, W.J.G., Meijer, Adam, Wolters, F., Bovenkamp, J. van de, Bosch, B. van den, Brink, S. van den, Broeders, M., Chung, N.H., Favie, B., Goderski, G., Kuijpers, J., Overdevest, I., Rahamat-Langendoen, J.C., Wijsman, L., Melchers, W.J.G., and Meijer, Adam

Abstract

Contains fulltext : 220114.pdf (Publisher’s version ) (Closed access), BACKGROUND: With the outbreak of SARS-CoV-2, rapid diagnostics are paramount to contain the current pandemic. The routinely used realtime RT-PCR is sensitive, specific and able to process large batches of samples. However, turnaround time is long and in cases where fast obtained results are critical, molecular point of care tests (POCT) can be an alternative. Here we report on a multicenter evaluation of the Cepheid Xpert Xpress SARS-CoV-2 point-of-care test. STUDY DESIGN: The Xpert Xpress SARS-CoV-2 assay was evaluated against the routine in-house real-time RT-PCR assays in three medical microbiology laboratories in The Netherlands. A sensitivity and specificity panel was tested consisting of a dilution series of SARS-CoV-2 and ten samples containing SARS-CoV-2 and a range of other seasonal respiratory viruses. Additionally, 58 samples of patients positive for SARS-CoV-2 with different viral loads and 30 tested negative samples in all three Dutch laboratories using an in-house RT-PCR, were evaluated using Cepheids Xpert Xpress SARS-CoV-2 cartridges. RESULTS: Xpert Xpress SARS-CoV-2 point of care test showed equal performance compared to routine in-house testing with a limit of detection (LOD) of 8.26 copies/mL. Other seasonal respiratory viruses were not detected. In clinical samples Xpert Xpress SARS-CoV-2 reaches an agreement of 100 % compared to all in-house RT-PCRs CONCLUSION: Cepheids GeneXpert Xpert Xpress SARS-CoV-2 is a valuable addition for laboratories in situations where rapid and accurate diagnostics are of the essence.

Published
2020

9. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR

Author

Corman, V.M. (Victor), Landt, O., Kaiser, M. (Marco), Molenkamp, R. (Richard), Meijer, A. (Adam), Chu, D.K. (Daniel Kw), Bleicker, T., Brunink, S. (Sebastian), Schneider, J. (Julia), Schmidt, M.L. (Marie Luisa), Mulders, D.G. (Daphne Gjc), Haagmans, B.L. (Bart), Veer, B. (Bas) van der, van den Brink, S. (Sharon), Wijsman, L. (Lisa), Goderski, G. (Gabriel), Romette, J.-L. (Jean-Louis), Ellis, J. (Joanna), Zambon, M.C. (Maria), Peiris, M. (Malik), Goossens, H., Reusken, C.B.E.M. (Chantal), Koopmans D.V.M., M.P.G. (Marion), Drosten, C. (Christian), Corman, V.M. (Victor), Landt, O., Kaiser, M. (Marco), Molenkamp, R. (Richard), Meijer, A. (Adam), Chu, D.K. (Daniel Kw), Bleicker, T., Brunink, S. (Sebastian), Schneider, J. (Julia), Schmidt, M.L. (Marie Luisa), Mulders, D.G. (Daphne Gjc), Haagmans, B.L. (Bart), Veer, B. (Bas) van der, van den Brink, S. (Sharon), Wijsman, L. (Lisa), Goderski, G. (Gabriel), Romette, J.-L. (Jean-Louis), Ellis, J. (Joanna), Zambon, M.C. (Maria), Peiris, M. (Malik), Goossens, H., Reusken, C.B.E.M. (Chantal), Koopmans D.V.M., M.P.G. (Marion), and Drosten, C. (Christian)

Abstract

BackgroundThe ongoing outbreak of the recently emerged novel coronavirus (2019-nCoV) poses a challenge for public health laboratories as virus isolates are unavailable while there is growing evidence that the outbreak is more widespread than initially thought, and international spread through travellers does already occur.AimWe aimed to develop and deploy robust diagnostic methodology for use in public health laboratory settings without having virus material available.MethodsHere we present a validated diagnostic workflow for 2019-nCoV, its design relying on close genetic relatedness of 2019-nCoV with SARS coronavirus, making use of synthetic nucleic acid technology.ResultsThe workflow reliably detects 2019-nCoV, and further discriminates 2019-nCoV from SARS-CoV. Through coordination between academic and public laboratories, we confirmed assay exclusivity based on 297 original clinical specimens containing a full spectrum of human respiratory viruses. Control material is made available through European Virus Archive - Global (EVAg), a European Union infrastructure project.ConclusionThe present study demonstrates the enormous response capacity achieved through coordination of academic and public laboratories in national and European research networks.

Published
2020
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10. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR

Author

Corman, VM, Landt, O, Kaiser, M, Molenkamp, Richard, Meijer, A, Chu, DKW, Bleicker, T, Brunink, S, Schneider, J, Schmidt, ML, Mulders, Daphne, Haagmans, Bart, ter Veer, B, van den Brink, S, Wijsman, L, Goderski, G, Romette, JL, Ellis, J, Zambon, M, Peiris, M, Goossens, H, Reusken, C, Koopmans, Marion, Drosten, C, Corman, VM, Landt, O, Kaiser, M, Molenkamp, Richard, Meijer, A, Chu, DKW, Bleicker, T, Brunink, S, Schneider, J, Schmidt, ML, Mulders, Daphne, Haagmans, Bart, ter Veer, B, van den Brink, S, Wijsman, L, Goderski, G, Romette, JL, Ellis, J, Zambon, M, Peiris, M, Goossens, H, Reusken, C, Koopmans, Marion, and Drosten, C

Published
2020

11. Self-testing for the detection of SARS-CoV-2 infection with rapid antigen tests

Author

Stohr, J. J.J.M., primary, Zwart, V. F., additional, Goderski, G., additional, Meijer, A., additional, Nagel-Imming, C. R.S., additional, Kluytmans-van den Bergh, M.F.Q., additional, Pas, S. D., additional, van den Oetelaar, F., additional, Hellwich, M., additional, Gan, K. H., additional, Rietveld, A., additional, Verweij, J.J., additional, Murk, J. L., additional, van den Bijllaardt, W., additional, and Kluytmans, J. A. J. W., additional

Published
2021
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12. Interim 2017/18 influenza seasonal vaccine effectiveness: combined results from five European studies

Author

Rondy, M, Kissling, E, Emborg, Hd, Gherasim, A, Pebody, R, Trebbien, R, Pozo, F, Larrauri, A, Mcmenamin, J, Valenciano, M, Kaic, B, Kurecic Filipovic, S, Visekruna-Vucina, V, Pem Novosel, I, Lovric, Z, Petrović, G, Krause, Tg, Fischer, Tk, Lina, B, Falchi, Antonella, Vilcu, Am, Souty, C, Blanchon, T, van der Werf, S, Enouf, V, Behillil, S, Valette, M, Bernard-Stoecklin, S, Lévy-Bruhl, D, Launay, O, Loulergue, P, Lenzi, N, Lesieur, Z, L'Honneur, As, Galtier, F, Agostini, C, Serrand, C, Merle, C, Foulongne, V, Vanhems, P, Lainé, F, Lagathu, G, Carrat, F, Buda, S, Preuss, U, Prahm, K, Schweiger, B, Wedde, M, Heider, A, Martin, M, Biere, B, Duerrwald, R, Domegan, L, Coughlan, L, O’Donnell, J, Joyce, M, Collins, C, Dunford, L, Martin Moran, Josè Manuel, Tuite, G, Duffy, M, Connell, J, de Gascun, C, Rizzo, C, Bella, A, Alfonsi, V, Castrucci, Mr, Puzelli, S, Pagani, E, Ghisetti, V, Pariani, E, Baldanti, F, Palù, G, D'Agaro, P, Ansaldi, F, Affanni, P, Rossolini, Gm, Camilloni, B, Bagnarelli, P, Sanguinetti, M, Atripaldi, L, Chironna, M, Serra, C, Vitale, F, Germinario, C, Orsi, A, Manini, I, Montomoli, E, Napoli, C, Orsi, Gb, Casado, I, Castilla, J, Fernandino, L, Martínez-Baz, I, Ezpeleta, G, Navascués, A, Pérez-García, A, Aguinaga, A, Ezpeleta, C, Meijer, A, van den Brink, S, van der Hoek, W, Goderski, G, Wijsman, L, Bagheri, M, Dijkstra, F, de Lange, M, Marzec, T, Overduin, P, Teirlinck, A, Wentink, E, Donker, G, Marbus, S, van Gageldonk- Lafeber, R, Schneeberger, P, van Oosterheert JJ, Schweitzer, V, Groeneveld, G, Nunes, B, RIBEIRO MACHADO, CARLOS AUGUSTO, Rodrigues, Ap, DIAZ GOMEZ, MARIA VANESSA, Kislaya, I, Guiomar, R, Pechirra, P, Cristóvão, P, Costa, I, Panarra, A, Côrte-Real, R, Poças, J, João Peres, M, García Comas, L, Marisquerena, Mei, Galán, Jc, Folgueira, D, Gonzalez Carril, F, Sancho Martínez, R, Cilla, G, García Cenoz, M, Quiñones Rubio, C, Martinez Ochoa, E, Blasco, M, Gimenez Duran, J, Vanrell, Jm, Reina, J, Castrillejo, D, Gherasim, Am, Delgado, C, Oliva, J, Casas, I, García, M, Latorre, M, Milagro Beamonte AM, Martinez Sapiñ, A, Oribe Amores, M, Aizpurúa, A, Montes, Marco, Zakikhany, K, Brytting, M, Wiman, Å, Carnahan, A, Warburton, F, Djennad, A, Ellis, J, Andrews, N, Marques, D, Cottrell, S, Reynolds, Alexander, Gunson, R, Galiano, M, Lackenby, A, Robertson, C, O’Doherty, M, Sinnathamby, M, Yonova, I, Moore, C, Sartaj, M, de Lusignan, S, Zambon, M, Moren, A, Penttinen, P., Unión Europea, EpiConcept [Paris], Statens Serum Institut [Copenhagen], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Pathogénèse et contrôle des infections chroniques (PCCI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre Hospitalier Universitaire de Montpellier (CHU Montpellier ), Rondy M., Kissling E., Emborg H.-D., Gherasim A., Pebody R., Trebbien R., Pozo F., Larrauri A., McMenamin J., Valenciano M., Kaic B., Filipovic S.K., Visekruna-Vucina V., Novosel I.P., Lovric Z., Petrovic G., Krause T.G., Fische T.K., Lina B., Falchi A., Vilcu A.-M., Souty C., Blanchon T., van der Werf S., Enouf V., Behillil S., Valette M., Bernard-Stoecklin S., Levy-Bruhl D., Launay O., Loulergue P., Lenzi N., Lesieur Z., L'Honneur A.-S., Galtier F., Agostini C., Serrand C., Merle C., Foulongne V., Vanhems P., Laine F., Lagathu G., Carrat F., Buda S., Preuss U., Prahm K., Schweiger B., Wedde M., Heider A., Martin M., Biere B., Duerrwald R., Domegan L., Coughlan L., O'Donnell J., Joyce M., Collins C., Dunford L., Moran J., Tuite G., Duffy M., Connell J., de Gascun C., Rizzo C., Bella A., Alfonsi V., Castrucci M.R., Puzelli S., Pagani E., Ghisetti V., Pariani E., Baldanti F., Palu G., D'Agaro P., Ansaldi F., Affanni P., Rossolini G.M., Camilloni B., Bagnarelli P., Sanguinetti M., Atripaldi L., Chironna M., Serra C., Vitale F., Germinario C., Orsi A., Manini I., Montomoli E., Napoli C., Orsi G.B., Casado I., Castilla J., Fernandino L., Martinez-Baz I., Ezpeleta G., Navascues A., Perez-Garcia A., Aguinaga A., Ezpeleta C., Meijer A., van den Brink S., van der Hoek W., Goderski G., Wijsman L., Bagheri M., Dijkstra F., de Lange M., Marzec T., Overduin P., Teirlinck A., Wentink E., Donker G., Marbus S., van Gageldonk-Lafeber R., Schneeberger P., van Oosterheert J.J., Schweitzer V., Groeneveld G., Nunes B., Machado A., Rodrigues A.P., Gomez V., Kislaya I., Guiomar R., Pechirra P., Cristovao P., Costa I., Panarra A., Corte-Real R., Pocas J., Peres M.J., Comas L.G., Marisquerena M.E.I., Galan J.C., Folgueira M.D., Carril F.G., Martinez R.S., Cilla G., Cenoz M.G., Rubio C.Q., Ochoa E.M., Blasco M., Duran J.G., Vanrell J.M., Reina J., Castrillejo D., Gherasim A.M., Delgado C., Oliva J., Casas I., Garcia M., Latorre M., Beamonte A.M.M., Sapina A.M., Amores M.O., Aizpurua A., Montes M., Zakikhany K., Brytting M., Wiman A., Carnahan A., Warburton F., Djennad A., Ellis J., Andrews N., Marques D., Cottrell S., Reynolds A., Gunson R., Galiano M., Lackenby A., Robertson C., O'Doherty M., Sinnathamby M., Yonova I., Moore C., Sartaj M., de Lusignan S., Zambon M., Moren A., Penttinen P., Génétique Moléculaire des Virus à ARN - Molecular Genetics of RNA Viruses (GMV-ARN (UMR_3569 / U-Pasteur_2)), Institut Pasteur [Paris] (IP)-Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Marc, Rondy, Esther, Kissling, Hanne-Dorthe, Emborg, Alin, Gherasim, Richard, Pebody, Ramona, Trebbien, Francisco, Pozo, Amparo, Larrauri, Jim, Mcmenamin, Marta, Valenciano, D'Agaro, Pierlanfranco, De Lusignan, S, and Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Montpellier (CHU Montpellier )-Université de Montpellier (UM)

Subjects
0301 basic medicine, Male, Pediatrics, Epidemiology, viruses, Influenza B viru, influenza, influenza vaccine effectiveness, influenza vaccination, case control study, multicentre study, Europe, Europe, case control study, influenza, influenza vaccination, influenza vaccine effectiveness, multicentre study, 0302 clinical medicine, Influenza A Virus, H1N1 Subtype, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Interim, Pandemic, Influenza A Virus, 030212 general & internal medicine, QA, Influenza vaccine effectiveness, Child, media_common, Vaccine Effectiveness, Vaccination, virus diseases, Middle Aged, 3. Good health, Treatment Outcome, Influenza Vaccines, Child, Preschool, H3N2 Subtype, Female, Seasons, Influenza Vaccine, Rapid Communication, Human, Adult, RM, medicine.medical_specialty, Adolescent, Influenza vaccine, 030106 microbiology, Case control study, Multicentre study, European studies, Settore MED/07 - MICROBIOLOGIA E MICROBIOLOGIA CLINICA, 03 medical and health sciences, Virology, Influenza, Human, medicine, media_common.cataloged_instance, Humans, H1N1 Subtype, Vacina Antigripal, European Union, European union, Preschool, Pandemics, Aged, Influenza A Virus, H3N2 Subtype, Cuidados de Saúde, Public Health, Environmental and Occupational Health, Infant, Newborn, Infant, Influenza a, influenza vaccine effectivene, Newborn, Influenza, respiratory tract diseases, Influenza vaccination, Influenza B virus, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Determinantes da Saúde e da Doença, [SDV.IMM.VAC]Life Sciences [q-bio]/Immunology/Vaccinology
Abstract

Between September 2017 and February 2018, influenza A(H1N1)pdm09, A(H3N2) and B viruses (mainly B/Yamagata, not included in 2017/18 trivalent vaccines) co-circulated in Europe. Interim results from five European studies indicate that, in all age groups, 2017/18 influenza vaccine effectiveness was 25 to 52% against any influenza, 55 to 68% against influenza A(H1N1)pdm09, -42 to 7% against influenza A(H3N2) and 36 to 54% against influenza B. 2017/18 influenza vaccine should be promoted where influenza still circulates. Funding: The five studies have received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 634446 to conduct the study in individuals aged 65 years or more. ECDC has contributed to fund some study sites of the EU-PC study under the Framework contract No ECDC/2014/026 for the individuals aged less than 65 years. All study teams are very grateful to all patients, general practitioners, paediatricians, hospital teams, laboratory teams, regional epidemiologists who have contributed to the studies. We acknowledge the authors, originating and submitting laboratories of the sequences from GISAID’s EpiFlu Database used for this study. All submitters of data may be contacted directly via the GISAID website www.gisaid.org Sí

Published
2018

14. Interim 2017/18 influenza seasonal vaccine effectiveness: Combined results from five European studies

Author

Rondy, M., Kissling, E., Emborg, H. -D., Gherasim, A., Pebody, R., Trebbien, R., Pozo, F., Larrauri, A., Mcmenamin, J., Valenciano, M., Kaic, B., Filipovic, S. K., Visekruna-Vucina, V., Novosel, I. P., Lovric, Z., Petrovic, G., Krause, T. G., Fische, T. K., Lina, B., Falchi, A., Vilcu, A. -M., Souty, C., Blanchon, T., van der Werf, S., Enouf, V., Behillil, S., Valette, M., Bernard-Stoecklin, S., Levy-Bruhl, D., Launay, O., Loulergue, P., Lenzi, N., Lesieur, Z., L'Honneur, A. -S., Galtier, F., Agostini, C., Serrand, C., Merle, C., Foulongne, V., Vanhems, P., Laine, F., Lagathu, G., Carrat, F., Buda, S., Preuss, U., Prahm, K., Schweiger, B., Wedde, M., Heider, A., Martin, M., Biere, B., Duerrwald, R., Domegan, L., Coughlan, L., O'Donnell, J., Joyce, M., Collins, C., Dunford, L., Moran, J., Tuite, G., Duffy, M., Connell, J., de Gascun, C., Rizzo, C., Bella, A., Alfonsi, V., Castrucci, M. R., Puzelli, S., Pagani, E., Ghisetti, V., Pariani, E., Baldanti, F., Palu, G., D'Agaro, P., Ansaldi, F., Affanni, P., Rossolini, G. M., Camilloni, B., Bagnarelli, P., Sanguinetti, Maurizio, Atripaldi, L., Chironna, M., Serra, C., Vitale, F., Germinario, C., Orsi, A., Manini, I., Montomoli, E., Napoli, C., Orsi, G. B., Casado, I., Castilla, J., Fernandino, L., Martinez-Baz, I., Ezpeleta, G., Navascues, A., Perez-Garcia, A., Aguinaga, A., Ezpeleta, C., Meijer, A., van den Brink, S., van der Hoek, W., Goderski, G., Wijsman, L., Bagheri, M., Dijkstra, F., de Lange, M., Marzec, T., Overduin, P., Teirlinck, A., Wentink, E., Donker, G., Marbus, S., van Gageldonk-Lafeber, R., Schneeberger, P., van Oosterheert, J. J., Schweitzer, V., Groeneveld, G., Nunes, B., Machado, A., Rodrigues, A. P., Gomez, V., Kislaya, I., Guiomar, R., Pechirra, P., Cristovao, P., Costa, I., Panarra, A., Corte-Real, R., Pocas, J., Peres, M. J., Comas, L. G., Marisquerena, M. E. I., Galan, J. C., Folgueira, M. D., Carril, F. G., Martinez, R. S., Cilla, G., Cenoz, M. G., Rubio, C. Q., Ochoa, E. M., Blasco, M., Duran, J. G., Vanrell, J. M., Reina, J., Castrillejo, D., Gherasim, A. M., Delgado, C., Oliva, J., Casas, I., Garcia, M., Latorre, M., Beamonte, A. M. M., Sapina, A. M., Amores, M. O., Aizpurua, A., Montes, M., Zakikhany, K., Brytting, M., Wiman, A., Carnahan, A., Warburton, F., Djennad, A., Ellis, J., Andrews, N., Marques, D., Cottrell, S., Reynolds, A., Gunson, R., Galiano, M., Lackenby, A., Robertson, C., O'Doherty, M., Sinnathamby, M., Yonova, I., Moore, C., Sartaj, M., de Lusignan, S., Zambon, M., Moren, A., Penttinen, P., Sanguinetti M. (ORCID:0000-0002-9780-7059), Rondy, M., Kissling, E., Emborg, H. -D., Gherasim, A., Pebody, R., Trebbien, R., Pozo, F., Larrauri, A., Mcmenamin, J., Valenciano, M., Kaic, B., Filipovic, S. K., Visekruna-Vucina, V., Novosel, I. P., Lovric, Z., Petrovic, G., Krause, T. G., Fische, T. K., Lina, B., Falchi, A., Vilcu, A. -M., Souty, C., Blanchon, T., van der Werf, S., Enouf, V., Behillil, S., Valette, M., Bernard-Stoecklin, S., Levy-Bruhl, D., Launay, O., Loulergue, P., Lenzi, N., Lesieur, Z., L'Honneur, A. -S., Galtier, F., Agostini, C., Serrand, C., Merle, C., Foulongne, V., Vanhems, P., Laine, F., Lagathu, G., Carrat, F., Buda, S., Preuss, U., Prahm, K., Schweiger, B., Wedde, M., Heider, A., Martin, M., Biere, B., Duerrwald, R., Domegan, L., Coughlan, L., O'Donnell, J., Joyce, M., Collins, C., Dunford, L., Moran, J., Tuite, G., Duffy, M., Connell, J., de Gascun, C., Rizzo, C., Bella, A., Alfonsi, V., Castrucci, M. R., Puzelli, S., Pagani, E., Ghisetti, V., Pariani, E., Baldanti, F., Palu, G., D'Agaro, P., Ansaldi, F., Affanni, P., Rossolini, G. M., Camilloni, B., Bagnarelli, P., Sanguinetti, Maurizio, Atripaldi, L., Chironna, M., Serra, C., Vitale, F., Germinario, C., Orsi, A., Manini, I., Montomoli, E., Napoli, C., Orsi, G. B., Casado, I., Castilla, J., Fernandino, L., Martinez-Baz, I., Ezpeleta, G., Navascues, A., Perez-Garcia, A., Aguinaga, A., Ezpeleta, C., Meijer, A., van den Brink, S., van der Hoek, W., Goderski, G., Wijsman, L., Bagheri, M., Dijkstra, F., de Lange, M., Marzec, T., Overduin, P., Teirlinck, A., Wentink, E., Donker, G., Marbus, S., van Gageldonk-Lafeber, R., Schneeberger, P., van Oosterheert, J. J., Schweitzer, V., Groeneveld, G., Nunes, B., Machado, A., Rodrigues, A. P., Gomez, V., Kislaya, I., Guiomar, R., Pechirra, P., Cristovao, P., Costa, I., Panarra, A., Corte-Real, R., Pocas, J., Peres, M. J., Comas, L. G., Marisquerena, M. E. I., Galan, J. C., Folgueira, M. D., Carril, F. G., Martinez, R. S., Cilla, G., Cenoz, M. G., Rubio, C. Q., Ochoa, E. M., Blasco, M., Duran, J. G., Vanrell, J. M., Reina, J., Castrillejo, D., Gherasim, A. M., Delgado, C., Oliva, J., Casas, I., Garcia, M., Latorre, M., Beamonte, A. M. M., Sapina, A. M., Amores, M. O., Aizpurua, A., Montes, M., Zakikhany, K., Brytting, M., Wiman, A., Carnahan, A., Warburton, F., Djennad, A., Ellis, J., Andrews, N., Marques, D., Cottrell, S., Reynolds, A., Gunson, R., Galiano, M., Lackenby, A., Robertson, C., O'Doherty, M., Sinnathamby, M., Yonova, I., Moore, C., Sartaj, M., de Lusignan, S., Zambon, M., Moren, A., Penttinen, P., and Sanguinetti M. (ORCID:0000-0002-9780-7059)

Abstract

Between September 2017 and February 2018, influenza A(H1N1)pdm09, A(H3N2) and B viruses (mainly B/Yamagata, not included in 2017/18 trivalent vaccines) co-circulated in Europe. Interim results from five European studies indicate that, in all age groups, 2017/18 influenza vaccine effectiveness was 25 to 52% against any influenza, 55 to 68% against influenza A(H1N1)pdm09, -42 to 7% against influenza A(H3N2) and 36 to 54% against influenza B. 2017/18 influenza vaccine should be promoted where influenza still circulates.

Published
2018

15. High quality of SARS-CoV-2 molecular diagnostics in a diverse laboratory landscape through supported benchmark testing and External Quality Assessment.

Author

Sluimer J, van den Akker WMR, Goderski G, Swart A, van der Veer B, Cremer J, Chung NH, Molenkamp R, Voermans J, Guldemeester J, Eggink D, Presser LD, and Meijer A

Subjects
Humans, Laboratories, Clinical Laboratory Techniques methods, COVID-19 Testing, Benchmarking, Pathology, Molecular, Sensitivity and Specificity, SARS-CoV-2 genetics, COVID-19 diagnosis, COVID-19 epidemiology
Abstract

A two-step strategy combining assisted benchmark testing (entry controls) and External Quality Assessments (EQAs) with blinded simulated clinical specimens to enhance and maintain the quality of nucleic acid amplification testing was developed. This strategy was successfully applied to 71 diagnostic laboratories in The Netherlands when upscaling the national diagnostic capacity during the SARS-CoV-2 pandemic. The availability of benchmark testing in combination with advice for improvement substantially enhanced the quality of the laboratory testing procedures for SARS-CoV-2 detection. The three subsequent EQA rounds demonstrated high quality testing with regard to specificity (99.6% correctly identified) and sensitivity (93.3% correctly identified). Even with the implementation of novel assays, changing workflows using diverse equipment and a high degree of assay heterogeneity, the overall high quality was maintained using this two-step strategy. We show that in contrast to the limited value of Cq value for absolute proxies of viral load, these Cq values can, in combination with metadata on strategies and techniques, provide valuable information for laboratories to improve their procedures. In conclusion, our two-step strategy (preparation phase followed by a series of EQAs) is a rapid and flexible system capable of scaling, improving, and maintaining high quality diagnostics even in a rapidly evolving (e.g. pandemic) situation., (© 2024. The Author(s).)

Published
2024
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16. Self-testing for the detection of SARS-CoV-2 infection with rapid antigen tests for people with suspected COVID-19 in the community.

Author

Stohr JJJM, Zwart VF, Goderski G, Meijer A, Nagel-Imming CRS, Kluytmans-van den Bergh MFQ, Pas SD, van den Oetelaar F, Hellwich M, Gan KH, Rietveld A, Verweij JJ, Murk JL, van den Bijllaardt W, and Kluytmans JAJW

Subjects
Antigens, Viral analysis, COVID-19 Testing, Humans, SARS-CoV-2 genetics, Self-Testing, Sensitivity and Specificity, COVID-19 diagnosis
Abstract

Objectives: To evaluate the performance of nasal mid-turbinate self-testing using rapid antigen detection tests (RDT) for persons with suspected coronavirus disease 2019 (COVID-19) in the community. Self-testing for COVID-19 infection with lateral flow assay severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RDT, provides rapid results and could enable frequent and extensive testing in the community, thereby improving the control of SARS-CoV-2., Methods: Participants visiting a municipal SARS-CoV-2 testing centre, received self-testing kits containing either the BD Veritor System (BD-RDT) or Roche SARS-CoV-2 antigen detection test (Roche-RDT). Oro-nasopharyngeal swabs were collected from the participants for quantitative RT-PCR (qRT-PCR) testing. As a proxy for contagiousness, viral culture was performed on a selection of qRT-PCR positive samples to determine the Ct-value at which the chance of a positive culture dropped below 0.5 (Ct-value cut-off). Sensitivity and specificity of self-testing were compared to qRT-PCR with a Ct-value below the Ct value cut-off. Determinants independently associated with a false-negative self-test result were determined., Results: A total of 3201 participants were included (BD-RDT n = 1595; Roche-RDT n = 1606). Sensitivity and specificity of self-testing compared with the qRT-PCR results with a Ct-value below the Ct-value cut-off were 78.4% (95% CI 73.2%-83.5%) and 99.4% (95% CI 99.1%-99.7%), respectively. A higher age was independently associated with a false-negative self-testing result with an odds ratio of 1.024 (95% CI 1.003-1.044)., Conclusions: Self-testing using currently available RDT has a high specificity and relatively high sensitivity to identify individuals with a high probability of contagiousness., (Copyright © 2021 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Published
2022
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17. Multi-center evaluation of Cepheid Xpert® Xpress SARS-CoV-2/Flu/RSV molecular point-of-care test.

Author

Sluimer J, Goderski G, van den Brink S, Broeders M, Rahamat-Langendoen J, Then E, Wijsman L, Wolters F, van de Bovenkamp J, Melchers WJ, and Meijer A

Abstract

Background: SARS-CoV-2 is taking a huge toll on society while influenza and RSV detection are also becoming more important. These viruses pose a high burden on health care. Rapid and accurate diagnostics for these pathogens are important for swift triage in the hospital. Fast molecular point of care test (mPOCT) assays for these pathogens can prove an alternative. Here a multi-center evaluation of the Xpert® Xpress SARS-CoV-2/Flu/RSV assay is reported., Study Design: The Xpert® Xpress SARS-CoV-2/Flu/RSV assay was compared to three reference assays at three Dutch medical microbiology laboratories. An external quality assessment panel consisting of 16 specimens containing SARS-CoV-2, influenza viruses, RSV or human seasonal coronaviruses, or a combination thereof were used. Clinical specimens containing SARS-CoV-2 ( n  = 57), influenza viruses ( n  = 21) or RSV ( n  = 12), at a wide range of relevant concentrations were used. One laboratory also tested zoonotic avian and swine influenza viruses, and eight relevant SARS-CoV-2 variants., Results: The Xpert® Xpress SARS-CoV-2/Flu/RSV assay showed equal performance compared to the reference assays. All SARS-CoV-2 variants of interest and variants of concern were accurately detected. Human seasonal coronaviruses were not detected. All four circulating seasonal influenza virus subtypes/lineages and both RSV types were accurately detected as well as a set of recent zoonotic avian and swine influenza viruses. The clinical specimens showed 98.2% concordance using this assay., Conclusion: The Xpert® Xpress SARS-CoV-2/Flu/RSV assay is a good alternative for accurate detection for SARS-CoV-2, influenza type A virus, influenza type B virus and RSV types A and B detection in a short timeframe., Competing Interests: None., (© 2021 The Author(s). Published by Elsevier Ltd.)

Published
2021
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18. Multi-center evaluation of cepheid xpert® xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic.

Author

Wolters F, van de Bovenkamp J, van den Bosch B, van den Brink S, Broeders M, Chung NH, Favié B, Goderski G, Kuijpers J, Overdevest I, Rahamat-Langedoen J, Wijsman L, Melchers WJ, and Meijer A

Subjects
Betacoronavirus genetics, COVID-19, COVID-19 Testing, COVID-19 Vaccines, Coronavirus Infections virology, Humans, Nasopharynx virology, Netherlands, Pneumonia, Viral virology, Reproducibility of Results, Reverse Transcriptase Polymerase Chain Reaction, SARS-CoV-2, Sensitivity and Specificity, Time Factors, Viral Load, Betacoronavirus isolation & purification, Clinical Laboratory Techniques methods, Coronavirus Infections diagnosis, Pandemics, Pneumonia, Viral diagnosis, Point-of-Care Testing
Abstract

Background: With the outbreak of SARS-CoV-2, rapid diagnostics are paramount to contain the current pandemic. The routinely used realtime RT-PCR is sensitive, specific and able to process large batches of samples. However, turnaround time is long and in cases where fast obtained results are critical, molecular point of care tests (POCT) can be an alternative. Here we report on a multicenter evaluation of the Cepheid Xpert Xpress SARS-CoV-2 point-of-care test., Study Design: The Xpert Xpress SARS-CoV-2 assay was evaluated against the routine in-house real-time RT-PCR assays in three medical microbiology laboratories in The Netherlands. A sensitivity and specificity panel was tested consisting of a dilution series of SARS-CoV-2 and ten samples containing SARS-CoV-2 and a range of other seasonal respiratory viruses. Additionally, 58 samples of patients positive for SARS-CoV-2 with different viral loads and 30 tested negative samples in all three Dutch laboratories using an in-house RT-PCR, were evaluated using Cepheids Xpert Xpress SARS-CoV-2 cartridges., Results: Xpert Xpress SARS-CoV-2 point of care test showed equal performance compared to routine in-house testing with a limit of detection (LOD) of 8.26 copies/mL. Other seasonal respiratory viruses were not detected. In clinical samples Xpert Xpress SARS-CoV-2 reaches an agreement of 100 % compared to all in-house RT-PCRs CONCLUSION: Cepheids GeneXpert Xpert Xpress SARS-CoV-2 is a valuable addition for laboratories in situations where rapid and accurate diagnostics are of the essence., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Published
2020
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19. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR.

Author

Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, Bleicker T, Brünink S, Schneider J, Schmidt ML, Mulders DG, Haagmans BL, van der Veer B, van den Brink S, Wijsman L, Goderski G, Romette JL, Ellis J, Zambon M, Peiris M, Goossens H, Reusken C, Koopmans MP, and Drosten C

Subjects
COVID-19 Testing, COVID-19 Vaccines, Coronavirus isolation & purification, Disease Outbreaks, Humans, RNA, Viral analysis, Real-Time Polymerase Chain Reaction methods, Sensitivity and Specificity, Clinical Laboratory Techniques methods, Coronavirus classification, Coronavirus genetics, Coronavirus Infections diagnosis, Coronavirus Infections virology
Abstract

Background: The ongoing outbreak of the recently emerged novel coronavirus (2019-nCoV) poses a challenge for public health laboratories as virus isolates are unavailable while there is growing evidence that the outbreak is more widespread than initially thought, and international spread through travellers does already occur., Aim: We aimed to develop and deploy robust diagnostic methodology for use in public health laboratory settings without having virus material available., Methods: Here we present a validated diagnostic workflow for 2019-nCoV, its design relying on close genetic relatedness of 2019-nCoV with SARS coronavirus, making use of synthetic nucleic acid technology., Results: The workflow reliably detects 2019-nCoV, and further discriminates 2019-nCoV from SARS-CoV. Through coordination between academic and public laboratories, we confirmed assay exclusivity based on 297 original clinical specimens containing a full spectrum of human respiratory viruses. Control material is made available through European Virus Archive - Global (EVAg), a European Union infrastructure project., Conclusion: The present study demonstrates the enormous response capacity achieved through coordination of academic and public laboratories in national and European research networks.

Published
2020
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