Development of Luminex Based Serological Test for COVID-19 Diagnosis and Monitoring

Coronavirus disease 2019 (Covid-19) is a global pandemic that has impacted the lives of the entire world’s population. Accurate and effective testing mechanisms to identify those with active infections or have convalesced is necessary to properly monitor and control this infectious agent. To this end, we have recently developed a serological method for assessment of an immune response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pathogen based on simultaneous evaluation of four viral antigens, including the Spike, Nucleocapsid, Membrane, and Envelope glycoproteins, and built on the Luminex immunobead platform. Validation studies against 1042 patients have provided test performance characteristics of 100% Sensitivity, 99.6% Specificity, and 99.62% overall accuracy, relative to PCR-based assignments. This quantitative method is highly effective in applications that include diagnosis of those with past infections (symptomatic or asymptomatic), epidemiological studies/ guidance for policy decisions, monitoring titers during vaccine trials, and rationalized donor selection for therapeutic ‘convalescent plasmapheresis’ strategies.

Learning Objectives:

1. To understand the best testing strategy to survey COVID-19 in population in order to constrain the disease and prepare for safe reopening

2. To understand the advantage of multiplexing technology to improve testing accuracy and sensitivity