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.
ABSTRACT
BACKGROUND: This is a retrospective study on a large hospital database to establish age- and sex-related mean values and reference ranges for serum creatinine (Scr), obtained with an IDMS-traceable, enzymatic method, in a Caucasian population. METHODS: The database was filtered for unique entries to reduce the presence of correlated and pathological data. Three different statistical methods, a non-parametric method, the Bhattacharya procedure and a non-linear fit of the cumulative Gaussian distribution were used to estimate the serum creatinine-age dependency for men and women, from birth till 100 years of age. RESULTS: Scr increases with age, equal for boys and girls, up to 14 years and with a much steeper slope for boys than for girls between 14 and 20 years. We show that the Scr-age pattern is constant between 20 and 70 years with a mean of 0.90 mg/dL [0.63-1.16 mg/dL] for men and 0.70 mg/dL [0.48-0.93 mg/dL] for women. Above 70, Scr starts to slowly increase again. CONCLUSIONS: Indirect methods confirm the available reference intervals from healthy-volunteer studies and add information on age-periods not covered by these studies. As such, indirect methods can be used complementary to healthy-volunteer studies.
