Objectives
The aim of this study was to evaluate the application of the Roche Elecsys anti-SARS-CoV2 assay to capillary dried blood samples for high throughput analyses on Roche COBAS 6000 systems.
Design and Methods
The performance of the of the Elecsys anti-SARS-CoV-2 assay was assessed using three sets of dried blood spot samples. Method correlation was performed using spiked blood samples. Sensitivity and specificity were calculated using paired donor samples. An additional cohort of 50 individuals, including COVID-19 convalescent cases, was used for the evaluation of at-home collection for mail transport, and stability studies.
Results
The Elecsys anti-SARS-CoV-2 assay using dried blood spot samples showed an excellent agreement of 98.9% with results obtained using their paired serum samples, and 86.7% accuracy with dried blood spots collected after 9 days from diagnostic (PCR) tests.
Conclusions
Capillary dried blood spot samples can be confidently used on Roche COBAS automated analyzers to monitor the epidemiology of COVID-19, and are suitable for use in large-scale screening programs.
At the first signs of the Covid-19 pandemic, the uncertainty around the global stock of medical supplies sparked a response in the DIY communities around the world. In the case of Spain, a community called Coronavirus Makers (CVM) emerged to supply ventilators and personal protection equipment (PPE) to hospitals and people in need. This paper explores the evolution of this community-driven development, detailing the patterns proposed by members of the group acting as design experts to tackle different problems. More specifically the paper uses face shields, the most produced PPE in Spain, as a boundary object to highlight the relationships amongst individuals, institutions, and companies. The objects of design, since they fall in the specific category of devices for medical use, have to overcome validation at the technical level. Authors will also explore some of the controversies surrounding the transfer of these products from horizontal innovation networks to traditional production companies.
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