Life (Jan 2022)
Reliable and Scalable SARS-CoV-2 qPCR Testing at a High Sample Throughput: Lessons Learned from the Belgian Initiative
- Steven Van Vooren,
- James Grayson,
- Marc Van Ranst,
- Elisabeth Dequeker,
- Lies Laenen,
- Reile Janssen,
- Laurent Gillet,
- Fabrice Bureau,
- Wouter Coppieters,
- Nathalie Devos,
- Benjamin Hengchen,
- Pierre Wattiau,
- Sibylle Méhauden,
- Yvan Verlinden,
- Kurt Van Baelen,
- Theresa Pattery,
- Jean-Pierre Valentin,
- Kris Janssen,
- Martine Geraerts,
- John Smeraglia,
- Jan Hellemans,
- Pieter Wytynck,
- Pieter Mestdagh,
- Nienke Besbrugge,
- René Höfer,
- Friedel Nollet,
- Jo Vandesompele,
- Pieter De Smet,
- John Lebon,
- Emmanuel Vandewynckele,
- Steven Verstrepen,
- Wouter Uten,
- Arnaud Capron,
- Hugues Malonne,
- Jeroen Poels,
- Emmanuel André
Affiliations
- Steven Van Vooren
- UgenTec, Inc., Cambridge, MA 02138, USA
- James Grayson
- UgenTec, Inc., Cambridge, MA 02138, USA
- Marc Van Ranst
- Department of Microbiology, Immunology and Transplantation, KU Leuven, B-3000 Leuven, Belgium
- Elisabeth Dequeker
- Clinical Department of Laboratory medicine and National Reference Center for Respiratory Pathogens, University Hospitals Leuven, B-3000 Leuven, Belgium
- Lies Laenen
- Department of Microbiology, Immunology and Transplantation, KU Leuven, B-3000 Leuven, Belgium
- Reile Janssen
- Clinical Department of Laboratory medicine and National Reference Center for Respiratory Pathogens, University Hospitals Leuven, B-3000 Leuven, Belgium
- Laurent Gillet
- Department of Microbiology, University of Liège, B-4000 Liège, Belgium
- Fabrice Bureau
- Department of Microbiology, University of Liège, B-4000 Liège, Belgium
- Wouter Coppieters
- Department of Microbiology, University of Liège, B-4000 Liège, Belgium
- Nathalie Devos
- GSK Vaccines, B-1330 Rixensart, Belgium
- Benjamin Hengchen
- GSK Vaccines, B-1330 Rixensart, Belgium
- Pierre Wattiau
- GSK Vaccines, B-1330 Rixensart, Belgium
- Sibylle Méhauden
- GSK Vaccines, B-1330 Rixensart, Belgium
- Yvan Verlinden
- Janssen Pharmaceutica N.V., Johnson & Johnson, B-2340 Beerse, Belgium
- Kurt Van Baelen
- Janssen Pharmaceutica N.V., Johnson & Johnson, B-2340 Beerse, Belgium
- Theresa Pattery
- Janssen Pharmaceutica N.V., Johnson & Johnson, B-2340 Beerse, Belgium
- Jean-Pierre Valentin
- UCB Pharma, B-1420 Braine l’Alleud, Belgium
- Kris Janssen
- UCB Pharma, B-1420 Braine l’Alleud, Belgium
- Martine Geraerts
- UCB Pharma, B-1420 Braine l’Alleud, Belgium
- John Smeraglia
- UCB Pharma, B-1420 Braine l’Alleud, Belgium
- Jan Hellemans
- Biogazelle, Technologiepark Zwijnaarde, B-9052 Zwijnaarde, Belgium
- Pieter Wytynck
- Biogazelle, Technologiepark Zwijnaarde, B-9052 Zwijnaarde, Belgium
- Pieter Mestdagh
- Biogazelle, Technologiepark Zwijnaarde, B-9052 Zwijnaarde, Belgium
- Nienke Besbrugge
- Biogazelle, Technologiepark Zwijnaarde, B-9052 Zwijnaarde, Belgium
- René Höfer
- Biogazelle, Technologiepark Zwijnaarde, B-9052 Zwijnaarde, Belgium
- Friedel Nollet
- Biogazelle, Technologiepark Zwijnaarde, B-9052 Zwijnaarde, Belgium
- Jo Vandesompele
- Biogazelle, Technologiepark Zwijnaarde, B-9052 Zwijnaarde, Belgium
- Pieter De Smet
- CliniSys|MIPS, B-9000 Ghent, Belgium
- John Lebon
- CliniSys|MIPS, B-9000 Ghent, Belgium
- Emmanuel Vandewynckele
- CliniSys|MIPS, B-9000 Ghent, Belgium
- Steven Verstrepen
- CliniSys|MIPS, B-9000 Ghent, Belgium
- Wouter Uten
- UgenTec n.v., B-3500 Hasselt, Belgium
- Arnaud Capron
- Sciensano, Belgian Institute for Health, B-1050 Brussels, Belgium
- Hugues Malonne
- Federal Agency for Medicines and Health Products (FAGG-AFMPS), B-1210 Brussels, Belgium
- Jeroen Poels
- Federal Agency for Medicines and Health Products (FAGG-AFMPS), B-1210 Brussels, Belgium
- Emmanuel André
- Department of Microbiology, Immunology and Transplantation, KU Leuven, B-3000 Leuven, Belgium
- DOI
- https://doi.org/10.3390/life12020159
- Journal volume & issue
-
Vol. 12,
no. 2
p. 159
Abstract
We present our approach to rapidly establishing a standardized, multi-site, nation-wide COVID-19 screening program in Belgium. Under auspices of a federal government Task Force responsible for upscaling the country’s testing capacity, we were able to set up a national testing initiative with readily available resources, putting in place a robust, validated, high-throughput, and decentralized qPCR molecular testing platform with embedded proficiency testing. We demonstrate how during an acute scarcity of equipment, kits, reagents, personnel, protective equipment, and sterile plastic supplies, we introduced an approach to rapidly build a reliable, validated, high-volume, high-confidence workflow based on heterogeneous instrumentation and diverse assays, assay components, and protocols. The workflow was set up with continuous quality control monitoring, tied together through a clinical-grade information management platform for automated data analysis, real-time result reporting across different participating sites, qc monitoring, and making result data available to the requesting physician and the patient. In this overview, we address challenges in optimizing high-throughput cross-laboratory workflows with minimal manual intervention through software, instrument and assay validation and standardization, and a process for harmonized result reporting and nation-level infection statistics monitoring across the disparate testing methodologies and workflows, necessitated by a rapid scale-up as a response to the pandemic.
Keywords