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1. Nationwide Harmonization Effort for Semi-Quantitative Reporting of SARS-CoV-2 PCR Test Results in Belgium

Author

Cuypers, Lize, primary, Bode, Jannes, additional, Beuselinck, Kurt, additional, Laenen, Lies, additional, Dewaele, Klaas, additional, Janssen, Reile, additional, Capron, Arnaud, additional, Lafort, Yves, additional, Paridaens, Henry, additional, Bearzatto, Bertrand, additional, Cauchie, Mathieu, additional, Huwart, Aline, additional, Degosserie, Jonathan, additional, Fagnart, Olivier, additional, Overmeire, Yarah, additional, Rouffiange, Arlette, additional, Vandecandelaere, Ilse, additional, Deffontaine, Marine, additional, Pilate, Thomas, additional, Yin, Nicolas, additional, Micalessi, Isabel, additional, Roisin, Sandrine, additional, Moons, Veronique, additional, Reynders, Marijke, additional, Steyaert, Sophia, additional, Henin, Coralie, additional, Lazarova, Elena, additional, Obbels, Dagmar, additional, Dufrasne, François E., additional, Pirenne, Hendri, additional, Schepers, Raf, additional, Collin, Anaëlle, additional, Verhasselt, Bruno, additional, Gillet, Laurent, additional, Jonckheere, Stijn, additional, Van Lint, Philippe, additional, Van den Poel, Bea, additional, Van der Beken, Yolien, additional, Stojkovic, Violeta, additional, Garrino, Maria-Grazia, additional, Segers, Hannah, additional, Vos, Kevin, additional, Godefroid, Maaike, additional, Pede, Valerie, additional, Nollet, Friedel, additional, Claes, Vincent, additional, Verschraegen, Inge, additional, Bogaerts, Pierre, additional, Van Gysel, Marjan, additional, Leurs, Judith, additional, Saegeman, Veroniek, additional, Soetens, Oriane, additional, Vanhee, Merijn, additional, Schiettekatte, Gilberte, additional, Huyghe, Evelyne, additional, Martens, Steven, additional, Lemmens, Ann, additional, Nailis, Heleen, additional, Laffineur, Kim, additional, Steensels, Deborah, additional, Vanlaere, Elke, additional, Gras, Jérémie, additional, Roussel, Gatien, additional, Gijbels, Koenraad, additional, Boudewijns, Michael, additional, Sion, Catherine, additional, Achtergael, Wim, additional, Maurissen, Wim, additional, Iliano, Luc, additional, Chantrenne, Marianne, additional, Vanheule, Geert, additional, Flies, Reinoud, additional, Hougardy, Nicolas, additional, Berth, Mario, additional, Verbeke, Vanessa, additional, Morent, Robin, additional, Vankeerberghen, Anne, additional, Bontems, Sébastien, additional, Kehoe, Kaat, additional, Schallier, Anneleen, additional, Ho, Giang, additional, Bafort, Kristof, additional, Raymaekers, Marijke, additional, Pypen, Yolande, additional, Heinrichs, Amelie, additional, Schuermans, Wim, additional, Cuigniez, Dominique, additional, Lali, Salah Eddine, additional, Drieghe, Stefanie, additional, Ory, Dieter, additional, Le Mercier, Marie, additional, Van Laethem, Kristel, additional, Thoelen, Inge, additional, Vandamme, Sarah, additional, Mansoor, Iqbal, additional, Vael, Carl, additional, De Sloovere, Maxime, additional, Declerck, Katrien, additional, Dequeker, Elisabeth, additional, Desmet, Stefanie, additional, Maes, Piet, additional, Lagrou, Katrien, additional, and André, Emmanuel, additional

Published
2022
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2. Nationwide Harmonization Effort for Semi-Quantitative Reporting of SARS-CoV-2 PCR Test Results in Belgium.

Author

UCL - (MGD) Laboratoire de biologie clinique, UCL - SSS/IREC/MONT - Pôle Mont Godinne, Cuypers, Lize, Bode, Jannes, Beuselinck, Kurt, Laenen, Lies, Dewaele, Klaas, Janssen, Reile, Capron, Arnaud, Lafort, Yves, Paridaens, Henry, Bearzatto, Bertrand, Cauchie, Mathieu, Huwart, Aline, Degosserie, Jonathan, Fagnart, Olivier, Overmeire, Yarah, Rouffiange, Arlette, Vandecandelaere, Ilse, Deffontaine, Marine, Pilate, Thomas, Yin, Nicolas, Micalessi, Isabel, Roisin, Sandrine, Moons, Veronique, Reynders, Marijke, Steyaert, Sophia, Henin, Coralie, Lazarova, Elena, Obbels, Dagmar, Dufrasne, François E, Pirenne, Hendri, Schepers, Raf, Collin, Anaëlle, Verhasselt, Bruno, Gillet, Laurent, Jonckheere, Stijn, Van Lint, Philippe, Van den Poel, Bea, Van der Beken, Yolien, Stojkovic, Violeta, Garrino, Maria-Grazia, Segers, Hannah, Vos, Kevin, Godefroid, Maaike, Pede, Valerie, Nollet, Friedel, Claes, Vincent, Verschraegen, Inge, Bogaerts, Pierre, Van Gysel, Marjan, Leurs, Judith, Saegeman, Veroniek, Soetens, Oriane, Vanhee, Merijn, Schiettekatte, Gilberte, Huyghe, Evelyne, Martens, Steven, Lemmens, Ann, Nailis, Heleen, Laffineur, Kim, Steensels, Deborah, Vanlaere, Elke, Gras, Jérémie, Roussel, Gatien, Gijbels, Koenraad, Boudewijns, Michael, Sion, Catherine, Achtergael, Wim, Maurissen, Wim, Iliano, Luc, Chantrenne, Marianne, Vanheule, Geert, Flies, Reinoud, Hougardy, Nicolas, Berth, Mario, Verbeke, Vanessa, Morent, Robin, Vankeerberghen, Anne, Bontems, Sébastien, Kehoe, Kaat, Schallier, Anneleen, Ho, Giang, Bafort, Kristof, Raymaekers, Marijke, Pypen, Yolande, Heinrichs, Amelie, Schuermans, Wim, Cuigniez, Dominique, Lali, Salah Eddine, Drieghe, Stefanie, Ory, Dieter, Le Mercier, Marie, Van Laethem, Kristel, Thoelen, Inge, Vandamme, Sarah, Mansoor, Iqbal, Vael, Carl, De Sloovere, Maxime, Declerck, Katrien, Dequeker, Elisabeth, Desmet, Stefanie, Maes, Piet, Lagrou, Katrien, André, Emmanuel, UCL - (MGD) Laboratoire de biologie clinique, UCL - SSS/IREC/MONT - Pôle Mont Godinne, Cuypers, Lize, Bode, Jannes, Beuselinck, Kurt, Laenen, Lies, Dewaele, Klaas, Janssen, Reile, Capron, Arnaud, Lafort, Yves, Paridaens, Henry, Bearzatto, Bertrand, Cauchie, Mathieu, Huwart, Aline, Degosserie, Jonathan, Fagnart, Olivier, Overmeire, Yarah, Rouffiange, Arlette, Vandecandelaere, Ilse, Deffontaine, Marine, Pilate, Thomas, Yin, Nicolas, Micalessi, Isabel, Roisin, Sandrine, Moons, Veronique, Reynders, Marijke, Steyaert, Sophia, Henin, Coralie, Lazarova, Elena, Obbels, Dagmar, Dufrasne, François E, Pirenne, Hendri, Schepers, Raf, Collin, Anaëlle, Verhasselt, Bruno, Gillet, Laurent, Jonckheere, Stijn, Van Lint, Philippe, Van den Poel, Bea, Van der Beken, Yolien, Stojkovic, Violeta, Garrino, Maria-Grazia, Segers, Hannah, Vos, Kevin, Godefroid, Maaike, Pede, Valerie, Nollet, Friedel, Claes, Vincent, Verschraegen, Inge, Bogaerts, Pierre, Van Gysel, Marjan, Leurs, Judith, Saegeman, Veroniek, Soetens, Oriane, Vanhee, Merijn, Schiettekatte, Gilberte, Huyghe, Evelyne, Martens, Steven, Lemmens, Ann, Nailis, Heleen, Laffineur, Kim, Steensels, Deborah, Vanlaere, Elke, Gras, Jérémie, Roussel, Gatien, Gijbels, Koenraad, Boudewijns, Michael, Sion, Catherine, Achtergael, Wim, Maurissen, Wim, Iliano, Luc, Chantrenne, Marianne, Vanheule, Geert, Flies, Reinoud, Hougardy, Nicolas, Berth, Mario, Verbeke, Vanessa, Morent, Robin, Vankeerberghen, Anne, Bontems, Sébastien, Kehoe, Kaat, Schallier, Anneleen, Ho, Giang, Bafort, Kristof, Raymaekers, Marijke, Pypen, Yolande, Heinrichs, Amelie, Schuermans, Wim, Cuigniez, Dominique, Lali, Salah Eddine, Drieghe, Stefanie, Ory, Dieter, Le Mercier, Marie, Van Laethem, Kristel, Thoelen, Inge, Vandamme, Sarah, Mansoor, Iqbal, Vael, Carl, De Sloovere, Maxime, Declerck, Katrien, Dequeker, Elisabeth, Desmet, Stefanie, Maes, Piet, Lagrou, Katrien, and André, Emmanuel

Abstract

From early 2020, a high demand for SARS-CoV-2 tests was driven by several testing indications, including asymptomatic cases, resulting in the massive roll-out of PCR assays to combat the pandemic. Considering the dynamic of viral shedding during the course of infection, the demand to report cycle threshold (Ct) values rapidly emerged. As Ct values can be affected by a number of factors, we considered that harmonization of semi-quantitative PCR results across laboratories would avoid potential divergent interpretations, particularly in the absence of clinical or serological information. A proposal to harmonize reporting of test results was drafted by the National Reference Centre (NRC) UZ/KU Leuven, distinguishing four categories of positivity based on RNA copies/mL. Pre-quantified control material was shipped to 124 laboratories with instructions to setup a standard curve to define thresholds per assay. For each assay, the mean Ct value and corresponding standard deviation was calculated per target gene, for the three concentrations (10, 10 and 10 copies/mL) that determine the classification. The results of 17 assays are summarized. This harmonization effort allowed to ensure that all Belgian laboratories would report positive PCR results in the same semi-quantitative manner to clinicians and to the national database which feeds contact tracing interventions.

Published
2022

4. Distribution of HCV genotypes in Belgium from 2008 to 2015

Author

Bouacida, Lobna, primary, Suin, Vanessa, additional, Hutse, Veronik, additional, Boudewijns, Michaël, additional, Cartuyvels, Reinoud, additional, Debaisieux, Laurent, additional, De Laere, Emmanuel, additional, Hallin, Marie, additional, Hougardy, Nicolas, additional, Lagrou, Katrien, additional, Oris, Els, additional, Padalko, Elizaveta, additional, Reynders, Marijke, additional, Roussel, Gatien, additional, Senterre, Jean-Marc, additional, Stalpaert, Michel, additional, Ursi, Dominique, additional, Vael, Carl, additional, Vaira, Dolores, additional, Van Acker, Jos, additional, Verstrepen, Walter, additional, Van Gucht, Steven, additional, Kabamba, Benoit, additional, Quoilin, Sophie, additional, and Muyldermans, Gaëtan, additional

Published
2018
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5. Heparin-Induced Thrombocytopenia

Author

Berkowitz, Noah, Beckman, Joshua, Shumate, Mark J., Hougardy, Nicolas, Machiels, Jean-Pascal, Ravoet, Christophe, Warkentin, Theodore E., Hirsh, Jack, and Kelton, John G.

Published
1995
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6. Distribution of HCV genotypes in Belgium from 2008 to 2015.

Author

UCL - SSS/IREC/MBLG - Pôle de Microbiologie médicale, UCL - (SLuc) Service de microbiologie, Bouacida, Lobna, Suin, Vanessa, Hutse, Veronik, Boudewijns, Michaël, Cartuyvels, Reinoud, Debaisieux, Laurent, De Laere, Emmanuel, Hallin, Marie, Hougardy, Nicolas, Lagrou, Katrien, Oris, Els, Padalko, Elizaveta, Reynders, Marijke, Roussel, Gatien, Senterre, Jean-Marc, Stalpaert, Michel, Ursi, Dominique, Vael, Carl, Vaira, Dolores, Van Acker, Jos, Verstrepen, Walter, Van Gucht, Steven, Kabamba-Mukadi, Benoît, Quoilin, Sophie, Muyldermans, Gaëtan, UCL - SSS/IREC/MBLG - Pôle de Microbiologie médicale, UCL - (SLuc) Service de microbiologie, Bouacida, Lobna, Suin, Vanessa, Hutse, Veronik, Boudewijns, Michaël, Cartuyvels, Reinoud, Debaisieux, Laurent, De Laere, Emmanuel, Hallin, Marie, Hougardy, Nicolas, Lagrou, Katrien, Oris, Els, Padalko, Elizaveta, Reynders, Marijke, Roussel, Gatien, Senterre, Jean-Marc, Stalpaert, Michel, Ursi, Dominique, Vael, Carl, Vaira, Dolores, Van Acker, Jos, Verstrepen, Walter, Van Gucht, Steven, Kabamba-Mukadi, Benoît, Quoilin, Sophie, and Muyldermans, Gaëtan

Abstract

BACKGROUND: The knowledge of circulating HCV genotypes and subtypes in a country is crucial to guide antiviral therapy and to understand local epidemiology. Studies investigating circulating HCV genotypes and their trends have been conducted in Belgium. However they are outdated, lack nationwide representativeness or were not conducted in the general population. METHODS: In order to determine the distribution of different circulating HCV genotypes in Belgium, we conducted a multicentre study with all the 19 Belgian laboratories performing reimbursed HCV genotyping assays. Available genotype and subtype data were collected for the period from 2008 till 2015. Furthermore, a limited number of other variables were collected: some demographic characteristics from the patients and the laboratory technique used for the determination of the HCV genotype. RESULTS: For the study period, 11,033 unique records collected by the participating laboratories were used for further investigation. HCV genotype 1 was the most prevalent (53.6%) genotype in Belgium, with G1a and G1b representing 19.7% and 31.6%, respectively. Genotype 3 was the next most prevalent (22.0%). Further, genotype 4, 2, and 5 were responsible for respectively 16.1%, 6.2%, and 1.9% of HCV infections. Genotype 6 and 7 comprise the remaining <1%. Throughout the years, a stable distribution was observed for most genotypes. Only for genotype 5, a decrease as a function of the year of analysis was observed, with respectively 3.6% for 2008, 2.3% for 2009 and 1.6% for the remaining years. The overall M:F ratio was 1.59 and was mainly driven by the high M:F ratio of 3.03 for patients infected with genotype 3. Patients infected with genotype 3 are also younger (mean age 41.7 years) than patients infected with other genotypes (mean age above 50 years for all genotypes). The patients for whom a genotyping assay was performed in 2008 were younger than those from 2015. Geographical distribution demonstrates that an important

Published
2018

7. Distribution of HCV genotypes in Belgium from 2008 to 2015

Author

Bouacida, Lobna, Suin, Vanessa, Hutse, Veronik, Boudewijns, Michaël, Cartuyvels, Reinoud, Debaisieux, Laurent, De Laere, Emmanuel, Hallin, Marie, Hougardy, Nicolas, Lagrou, Katrien, Oris, Els, Padalko, Elizaveta, Reynders, Marijke, Roussel, Gatien, Senterre, Jean Marc, Stalpaert, Michel, Ursi, Dominique, Vael, Carl, Vaira, Dolores, Van Acker, Jos, Verstrepen, Walter, Van Gucht, Steven, Kabamba-Mukadi, Benoît, Quoilin, Sophie, Muyldermans, Gaëtan, Bouacida, Lobna, Suin, Vanessa, Hutse, Veronik, Boudewijns, Michaël, Cartuyvels, Reinoud, Debaisieux, Laurent, De Laere, Emmanuel, Hallin, Marie, Hougardy, Nicolas, Lagrou, Katrien, Oris, Els, Padalko, Elizaveta, Reynders, Marijke, Roussel, Gatien, Senterre, Jean Marc, Stalpaert, Michel, Ursi, Dominique, Vael, Carl, Vaira, Dolores, Van Acker, Jos, Verstrepen, Walter, Van Gucht, Steven, Kabamba-Mukadi, Benoît, Quoilin, Sophie, and Muyldermans, Gaëtan

Abstract

Background The knowledge of circulating HCV genotypes and subtypes in a country is crucial to guide antiviral therapy and to understand local epidemiology. Studies investigating circulating HCV genotypes and their trends have been conducted in Belgium. However they are outdated, lack nationwide representativeness or were not conducted in the general population. Methods In order to determine the distribution of different circulating HCV genotypes in Belgium, we conducted a multicentre study with all the 19 Belgian laboratories performing reimbursed HCV genotyping assays. Available genotype and subtype data were collected for the period from 2008 till 2015. Furthermore, a limited number of other variables were collected: some demographic characteristics from the patients and the laboratory technique used for the determination of the HCV genotype. Results For the study period, 11,033 unique records collected by the participating laboratories were used for further investigation. HCV genotype 1 was the most prevalent (53.6%) genotype in Belgium, with G1a and G1b representing 19.7% and 31.6%, respectively. Genotype 3 was the next most prevalent (22.0%). Further, genotype 4, 2, and 5 were responsible for respectively 16.1%, 6.2%, and 1.9% of HCV infections. Genotype 6 and 7 comprise the remaining <1%. Throughout the years, a stable distribution was observed for most genotypes. Only for genotype 5, a decrease as a function of the year of analysis was observed, with respectively 3.6% for 2008, 2.3% for 2009 and 1.6% for the remaining years. The overall M:F ratio was 1.59 and was mainly driven by the high M:F ratio of 3.03 for patients infected with genotype 3. Patients infected with genotype 3 are also younger (mean age 41.7 years) than patients infected with other genotypes (mean age above 50 years for all genotypes). The patients for whom a genotyping assay was performed in 2008 were younger than those from 2015. Geographical distribution demonstrates that an important num, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2018

9. Leucémie monoblastique aiguë congénitale : À propos d'un cas et diagnostic différentiel

Author

UCL - (SLuc) Service d'hématologie et d'oncologie pédiatrique, Dekeyser, Mélanie, Hougardy, Nicolas, Denoncin, Catherine, Chantrain, Christophe, Goffinet, Pierre, Grandjean, Frédéric, UCL - (SLuc) Service d'hématologie et d'oncologie pédiatrique, Dekeyser, Mélanie, Hougardy, Nicolas, Denoncin, Catherine, Chantrain, Christophe, Goffinet, Pierre, and Grandjean, Frédéric

Abstract

La leucémie aiguë est une pathologie rare chez le nouveau-né. Elle entraîne cependant de nombreux problèmes tant pour le clinicien que pour le biologiste amené à la prendre en charge. Bien que d’étiologie inconnue, le développement d’une leucémie aiguë néonatale suggère un réarrangement chromosomique. Plusieurs réarrangements chromosomiques particuliers, courants en cas de leucémie congénitale, ont été identifiés impliquant fréquemment le gène MLL. Le diagnostic différentiel est malaisé et inclut différentes pathologies régulièrement retrouvées en période néo-natale. Nous rapportons le cas d’un nouveau-né développant une leucémie monoblastique aiguë une heure après sa naissance. La cytogénétique a révélé un réarrangement du gène MLL. L’enfant a été traitée selon le protocole ELAM 02. Malheureusement, elle a développé une défaillance multiviscérale quelques jours plus tard et est décédée à cinq semaines

Published
2011

11. Heparin-induced thrombocytopenia.

Author

UCL - MD/MINT - Département de médecine interne, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Hougardy, Nicolas, Machiels, Jean-Pascal, Ravoet, Christophe, UCL - MD/MINT - Département de médecine interne, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Hougardy, Nicolas, Machiels, Jean-Pascal, and Ravoet, Christophe

Published
1995

13. Heparin-Induced Thrombocytopenia.

Author

Hougardy, Nicolas, Machiels, Jean-Pascal, and Ravoet, Christophe

Subjects
*LETTERS to the editor, *HEPARIN
Abstract

A letter to the editor is presented in response to the article "Heparin-induced thrombocytopenia in patients treated with low-molecular-weight heparin or unfractionated heparin," by T.E. Warkentin, M.N. Levine and J. Hirsh et al. in the May 18, 1995 issue.

Published
1995
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14. Nationwide Harmonization Effort for Semi-Quantitative Reporting of SARS-CoV-2 PCR Test Results in Belgium

Author

Lize Cuypers, Jannes Bode, Kurt Beuselinck, Lies Laenen, Klaas Dewaele, Reile Janssen, Arnaud Capron, Yves Lafort, Henry Paridaens, Bertrand Bearzatto, Mathieu Cauchie, Aline Huwart, Jonathan Degosserie, Olivier Fagnart, Yarah Overmeire, Arlette Rouffiange, Ilse Vandecandelaere, Marine Deffontaine, Thomas Pilate, Nicolas Yin, Isabel Micalessi, Sandrine Roisin, Veronique Moons, Marijke Reynders, Sophia Steyaert, Coralie Henin, Elena Lazarova, Dagmar Obbels, François E. Dufrasne, Hendri Pirenne, Raf Schepers, Anaëlle Collin, Bruno Verhasselt, Laurent Gillet, Stijn Jonckheere, Philippe Van Lint, Bea Van den Poel, Yolien Van der Beken, Violeta Stojkovic, Maria-Grazia Garrino, Hannah Segers, Kevin Vos, Maaike Godefroid, Valerie Pede, Friedel Nollet, Vincent Claes, Inge Verschraegen, Pierre Bogaerts, Marjan Van Gysel, Judith Leurs, Veroniek Saegeman, Oriane Soetens, Merijn Vanhee, Gilberte Schiettekatte, Evelyne Huyghe, Steven Martens, Ann Lemmens, Heleen Nailis, Kim Laffineur, Deborah Steensels, Elke Vanlaere, Jérémie Gras, Gatien Roussel, Koenraad Gijbels, Michael Boudewijns, Catherine Sion, Wim Achtergael, Wim Maurissen, Luc Iliano, Marianne Chantrenne, Geert Vanheule, Reinoud Flies, Nicolas Hougardy, Mario Berth, Vanessa Verbeke, Robin Morent, Anne Vankeerberghen, Sébastien Bontems, Kaat Kehoe, Anneleen Schallier, Giang Ho, Kristof Bafort, Marijke Raymaekers, Yolande Pypen, Amelie Heinrichs, Wim Schuermans, Dominique Cuigniez, Salah Eddine Lali, Stefanie Drieghe, Dieter Ory, Marie Le Mercier, Kristel Van Laethem, Inge Thoelen, Sarah Vandamme, Iqbal Mansoor, Carl Vael, Maxime De Sloovere, Katrien Declerck, Elisabeth Dequeker, Stefanie Desmet, Piet Maes, Katrien Lagrou, Emmanuel André, Dufrasne, Francois/0000-0001-6288-7936, Yin, Nicolas/0000-0003-1706-6869, Van Laethem, Kristel/0000-0001-6036-2271, Micalessi, Isabel, Ory , Dieter, Dequeker, Elisabeth, CLAES , Vincent, Verhasselt, Bruno, Moons, Veronique, Soetens, Oriane, Godefroid, Maaike, Verschraegen, Inge, Pirenne, Hendri, Gillet, Laurent, Heinrichs, Amelie, Huwart, Aline, Vanhee, Merijn, Vandamme, Sarah, Maurissen, Wim, Laenen , Lies, Reynders , Marijke, Thoelen, Inge, Gras, Jeremie, Berth, Mario, Obbels, Dagmar, Vanheule, Geert, Maes, Piet, Bafort, Kristof, Flies, Reinoud, Janssen, Reile, van den Poel, Bea, Bontems, Sebastien, Schepers , Raf, Overmeire, Yarah, Boudewijns, Michael, van der Beken, Yolien, Cuypers , Lize, Bode, Jannes, Vos, Kevin, Paridaens, Henry, Achtergael, Wim, Saegeman, Veroniek, Rouffiange, Arlette, Dewaele, Klaas, Pypen, Yolande, Yin, Nicolas, Drieghe, Stefanie, Nailis, Heleen, Kehoe, Kaat, DE SMET, Stefanie, Verbeke, Vanessa, Vanlaere, Elke, Vael, Carl, Van Laethem, Kristel, Segers, Hannah, Pede, Valerie, Deffontaine, Marine, Martens , Steven, Lemmens, Ann, Vankeerberghen, Anne, Lagrou, Katrien, Iliano, Luc, Chantrenne, Marianne, Laffineur, Kim, Bearzatto, Bertrand, Vandecandelaere, Ilse, Sion, Catherine, Andre, Emmanuel, Cuigniez, Dominique, Pilate, Thomas, Capron, Arnaud, Nollet, Friedel, Roisin, Sandrine, Gijbels, Koenraad, Van Lint, Philippe, Bogaerts, Pierre, Lafort, Yves, Henin, Coralie, Van Gysel, Marjan, Huyghe, Evelyne, Lali, Salah Eddine, Roussel, Gatien, Garrino, Maria-Grazia, Schuermans, Wim, Steyaert, Sophia, Le Mercier, Marie, De Sloovere, Maxime, Leurs, Judith, STEENSELS, Deborah, Declerck, Katrien, Dufrasne, Francois E., Fagnart, Olivier, Ho, Giang, Lazarova, Elena, Schallier, Anneleen, Beuselinck, Kurt, Morent, Robin, Hougardy, Nicolas, Raymaekers, Marijke, Jonckheere, Stijn, Stojkovic, Violeta, Degosserie, Jonathan, Cauchie, Mathieu, Schiettekatte, Gilberte, Collin, Anaelle, Mansoor, Iqbal, Faculty of Economic and Social Sciences and Solvay Business School, Faculty of Medicine and Pharmacy, Supporting clinical sciences, Microbiology and Infection Control, Clinical Biology, Experimental Pharmacology, Department of Clinical Microbiology, Faculty of Psychology and Educational Sciences, UCL - (MGD) Laboratoire de biologie clinique, and UCL - SSS/IREC/MONT - Pôle Mont Godinne

Subjects
SARS-CoV-2, PCR, semi-quantitative reporting, RNA copies/mL, infectivity, COVID-19/diagnosis, COVID-19, Real-Time Polymerase Chain Reaction, mL, Infectious Diseases, Belgium, SARS-CoV-2/genetics, Virology, Humans, RNA copies, Human medicine, Belgium/epidemiology, Pandemics
Abstract

From early 2020, a high demand for SARS-CoV-2 tests was driven by several testing indications, including asymptomatic cases, resulting in the massive roll-out of PCR assays to combat the pandemic. Considering the dynamic of viral shedding during the course of infection, the demand to report cycle threshold (Ct) values rapidly emerged. As Ct values can be affected by a number of factors, we considered that harmonization of semi-quantitative PCR results across laboratories would avoid potential divergent interpretations, particularly in the absence of clinical or serological information. A proposal to harmonize reporting of test results was drafted by the National Reference Centre (NRC) UZ/KU Leuven, distinguishing four categories of positivity based on RNA copies/mL. Pre-quantified control material was shipped to 124 laboratories with instructions to setup a standard curve to define thresholds per assay. For each assay, the mean Ct value and corresponding standard deviation was calculated per target gene, for the three concentrations (10(7), 10(5) and 10(3) copies/mL) that determine the classification. The results of 17 assays are summarized. This harmonization effort allowed to ensure that all Belgian laboratories would report positive PCR results in the same semi-quantitative manner to clinicians and to the national database which feeds contact tracing interventions. UZ/KU Leuven: as National Reference Center for Respiratory Pathogens, is supported by Sciensano, which is gratefully acknowledged. We would like to acknowledge additional staff members of the participating laboratories that contributed to this study: Jean-Luc Gala, Benoit Kabamba, Elsa Wiam, Valentin Coste, Paul Blanpain, Jean Ruelle, Ari Serbetciyan, Nicolas Pinte, Ophélie Simon and the entire UCLouvain federal testing platform COVID-19 team (all affiliation 4), Aurore Demars (affiliation 7), Laura Vanden Daele (affiliation 9), Hanne Valgaeren (affiliation 22), Guillaume Bayon-Vicente (affiliation 23), Fabrice Bureau, Claire Gourzonès and Joey Schyns (affiliation 28), Stéphanie Evrard (affiliation 42), Clara Ceyssens (affiliation 58), Jorn Hellemans (affiliation 77), Bram Slechten (affiliation 86) and the entire team of the laboratory of microbiology of UZA (affiliation 89) and of the UZA Federal testing platform COVID-19 (affiliation 85) for their boundless dedication.

Published
2022

15. Clinical validation of the Roche cobas HPV test on the Roche cobas 5800 system for the purpose of cervical screening.

Author

Mehta N, Keung MHT, Pineda E, Lynn E, Fetene D, Lee A, Hougardy N, Heinrichs A, Chan HTM, Arbyn M, Saville M, and Hawkes D

Subjects
Humans, Female, Adult, Reproducibility of Results, Middle Aged, Papillomaviridae genetics, Papillomaviridae isolation & purification, Papillomaviridae classification, Mass Screening methods, Aged, Uterine Cervical Dysplasia diagnosis, Uterine Cervical Dysplasia virology, Human papillomavirus 18 genetics, Human papillomavirus 18 isolation & purification, Human papillomavirus 16 genetics, Human papillomavirus 16 isolation & purification, Cervix Uteri virology, Genotype, Papillomavirus Infections diagnosis, Papillomavirus Infections virology, Sensitivity and Specificity, Uterine Cervical Neoplasms diagnosis, Uterine Cervical Neoplasms virology, Early Detection of Cancer methods
Abstract

This study assessed the relative clinical sensitivity and specificity, as well as reproducibility, for high-risk HPV types of the Roche cobas HPV test when processed using the Roche cobas 5800 system. The results from this study demonstrate that the cobas HPV test using the cobas 5800 system fulfils the Meijer criteria for use in population-based cervical screening. This clinical validation study also examines the clinical sensitivity and specificity based on partial genotyping, with separate detection of HPV16 and HPV18, compared with the Roche cobas 4800 HPV test, a second-generation standard comparator assay. The cobas HPV test has a relative clinical sensitivity of 1.000, when compared with the cobas 4800 HPV test to detect histologically confirmed CIN2+ lesions in woman aged 30 years or older, with a relative clinical specificity of 0.995. The general intra- and inter-laboratory agreement for the cobas HPV test on the cobas 5800 system for finding a HPV positive result were 99.1% and 99.6%, respectively.IMPORTANCEThis study demonstrates, for the first time, the clinical performance of the Roche cobas HPV test when processed using the new cobas 5800 system [cobas (5800)]. This study shows that the cobas (5800) demonstrates relative clinical sensitivity and specificity, when compared with a standard comparator HPV test, which meets the international HPV test validation requirements. Intra- and inter-laboratory reproducibility also fulfills these criteria. The current study demonstrates that the cobas (5800) can be used for primary HPV-based cervical screening on cervical specimens., Competing Interests: VCS Pathology (employer of N.M., M.H.T.K., E.P., E.L., H.T.M.C., M.S., and D.H.), a division of ACPCC, has received research funding or gratis consumables to support laboratory-based research from the following commercial entities in the last 3 years: Abbott, AusDiagnostics, BD, Cepheid, Copan, Qiagen, Roche, Rovers, and Seegene. D.H. is an investigator on the Compass, MaRVE, and SCoPE2(VALHUDES) clinical trials. M.S. is a co-principal investigator (PI) of an investigator-initiated trial of HPV screening in Australia (Compass), which is conducted and funded by the Australian Center for the Prevention of Cervical Cancer (ACPCC), a government-funded health promotion charity. The ACPCC has previously received equipment and a funding contribution for the Compass trial from Roche Molecular Systems USA. M.S. is also a co-PIs on a major implementation program, "Elimination of Cervical Cancer in the Western Pacific," which receives support from the Minderoo Foundation and equipment donations from Cepheid Inc. M.A. was supported by the Horizon 2020 Framework Program for Research and Innovation of the European Commission, through the RISCC Network (Grant No. 847845). Sciensano, the employer of M. Arbyn received funding from the European Society of Gynecological Oncology (ESGO), German Guideline Program in Oncology (German Cancer Aid project), World Health Organization (Geneva, Switzerland, via Agreement for Performance of Work for guidelines on Screening and Treatment of Pre-Invasive Cervical Disease); the European Commission Initiative on Cervical Cancer (EC-CvC) and the VALGENT and VALHUDES projects. D.F., A.L., N.H., and A.H. have no conflicts of interest.

Published
2024
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