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.
Highlights
Introduction to the Testing Initiative andEarly Consortium ActivitiesIn early 2020, the PCR-testing capacity for COVID-19 in Belgium was limited to one national reference laboratory—The National Reference Center for Respiratory Pathogens (NRC) at the University Hospitals of Leuven (UZ Leuven)
A real-time dashboard was available for each partner to monitor their sample flow, data analysis, and result reporting; insights into sample flows, key QC metrics, and test positivity rates were available to the consortium
Testing capacity and TaT were maintained through initially limiting consortium testing to symptomatic patients in high-risk centers such as elder care facilities, nursing homes, and correction facilities
Summary
In early 2020, the PCR-testing capacity for COVID-19 in Belgium was limited to one national reference laboratory—The National Reference Center for Respiratory Pathogens (NRC) at the University Hospitals of Leuven (UZ Leuven). With platform and assay selection limited by available resources, the partnering laboratories made use of a variety of assays, protocols, controls, liquid handling, and thermocycler instrumentation This significantly shortened the time from validation to routine testing and helped bring capacity online within weeks. With stringent requirements on timeline to deployment, the task force opted to allow the participating partners to retain control over their respective personnel and assay validation processes, standard operating procedures, and lab protocols of choice. This allowed accelerating the implementation of a sizeable emergency testing capacity. When supply chain issues eased, labs continued to rely on multiple technologies in order to maintain robustness against future supply chain gaps
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