The Coronavirus Standards Working Group’s roadmap for improved population testing
. However, relying on evaluation by positive agreement to a comparator test can be problematic, as it can propagate inaccuracies, differences or limitations that are present in the benchmark RT-qPCR method.
Reference materials for COVID-19 serology tests are typically derived from convalescent patient serum. The WHO International Standard, prepared and supplied by US National Institute for Biological Standards and Control , comprises a pool of convalescent plasma from recovered COVID-19 patients, with plasma from healthy donors collected before the pandemic serving as a negative control
Standardization for serological testing also underpins reproducible research in epidemiology and the development of vaccines and therapeutics. Large-scale studies have used serology testing to understand the transmission of SARS-CoV-2 through populations, as well as the impact of vaccination on this transmission. Without standardizing these serology tests, comparison among datasets and populations can be inaccurate, resulting in a lost opportunity for research that can be used in further work.
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