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2. 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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3. 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

10. Performance of three automated SARS-CoV-2 antibody assays and relevance of orthogonal testing algorithms.

Author

Huyghe, Evelyne, Jansens, Hilde, Matheeussen, Veerle, Hoffbauer, Ilse, Goossens, Herman, and Peeters, Bart

Subjects
*SARS-CoV-2, *COVID-19, *IMMUNOGLOBULINS, *VIRAL antibodies, *PANDEMICS, *ALGORITHMS
Abstract

Objectives: Development and implementation of SARS-CoV-2 serologic assays gained momentum. Laboratories keep on investigating the performance of these assays. In this study, we compared three fully automated SARS-CoV-2 antibody assays. Methods: A total of 186 samples from 84 PCR-positive COVID-19 patients and 120 control samples taken before the SARS-CoV-2 pandemic were analyzed using commercial serologic assays from Roche, Siemens and DiaSorin. Time after the positive COVID-19 PCR result and onset of symptoms was retrieved from the medical record. An extended golden standard, using the result of all three assays was defined, judging if antibodies are present or absent in a sample. Diagnostic and screening sensitivity/specificity and positive/negative predictive value were calculated. Results: Diagnostic sensitivity (ability to detect a COVID-19 positive patient) ≥14 days after positive PCR testing was 96.7% (95% CI 88.5–99.6%) for DiaSorin, 93.3% (95% CI 83.8–98.2%) for Roche and 100% (95% CI 94.0–100%) for Siemens. Lower diagnostic sensitivities were observed <14 days after onset of symptoms for all three assay. Diagnostic specificity (ability to detect a COVID-19 negative patient) was 95.0% (95% CI 89.4–98.1%) for DiaSorin, 99.2% (95% CI 95.4–99.9%) for Roche and 100% (95% CI 97.0–100%) for Siemens. The sensitivity/specificity for detecting antibodies (ability of detecting absence (specificity) or presence (sensitivity) of COVID-19 antibodies) was 92.4% (95% CI 86.4–96.3%)/94.9% (95% CI 90.5–97.6%) for DiaSorin, 97.7% (95% CI 93.5–99.5%)/97.1% (95% CI 93.5–99.1%) for Roche and 98.5% (95% CI 94.6–99.8)/97.1 (95% CI 93.5–99.1%) for Siemens. Conclusions: This study revealed acceptable performance for all three assays. An orthogonal testing algorithm using the Siemens and Roche assay achieved the highest positive predictive values for antibody detection in low seroprevalence settings. [ABSTRACT FROM AUTHOR]

Published
2021
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11. 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

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