International coronavirus researchers are calling for consistent standards for disease test development in the wide world of emerging infectious diseases and public health emergencies. Los Alamos scientists Patrick Chain, Alina Deshpande and Po-E Li of the Bioscience division are part of the Coronavirus Standards Working Group whose paper is out in the journal Nature Biotechnology.
Taking the lessons learned in the SARS-CoV-2 pandemic, the working group examined the various stages of process to develop tests, including the tests’ sensitivity and specificity for detecting the target. The scientists determined that specific standards for each stage of the process — from sample preparation to reference material used to results reporting — are critical to effective analysis. Standards are needed across the board, they point out, whether it is for evolving testing methods, serological testing, genomics or wastewater surveillance.
The testing standards must be consistent worldwide, the authors note, “calibrated and benchmarked with standards to harmonize performance and results, and those standards must be maintained as novel SARS-CoV-2 variants emerge.”
Lab’s insights came from testing its own employees
“Here at Los Alamos, we operated a government-certified COVID testing lab for the institution during the pandemic, and our experience with testing and evaluation helped us contribute to the development of the roadmap in a meaningful way,” said Bioscience Deputy Division Leader and author Alina Deshpande. Deshpande explained that various labs worldwide should be able to deliver the same results if given the same sample to test; however, without testing current standards this situation isn’t necessarily possible at this time.
“The pandemic has focused media, government and community attention on the importance of testing. However, while extensive resources have been invested in new testing methods, relatively fewer resources have been invested in the development of standards, despite their proven effectiveness. … Accordingly, we call for renewed consideration and investment to be afforded to standards, commensurate with the strategic, far-reaching and impactful benefits. Standards are a simple and proven method to assure a robust and effective testing enterprise at the massive scale and diversity that we have witnessed during the COVID-19 pandemic,” the authors state.
The paper’s authors propose to establish an enduring working group, termed the Emerging Infectious Disease Standards Working Group (EIDSWG), to advocate for testing standards in emerging infectious diseases and future public health emergencies.
Read the story in Nature Biotechnology.