Brand name justification.docx

a. Brand name justification: We propose to analyze longitudinal plasma samples from study participants for multiple inflammatory cytokines, chemokines, and interferons using the Biotechne Protein-Simple Simple Plex Assay platform that quantitatively measures inflammatory biomarkers in plasma. We will compare results from participants with Long-COVID to participants recovered from COVID-19 who do not have persistent symptoms and to Controls who have not been infected with SARS-CoV-2. Biotechne/Protein-Simple is the only manufacture of Simple Plex reagents and thus should be considered as a sole source. Change in manufacturer and reagents will be detrimental to the current studies because it will introduce variability into the current patient data set and established clinical protocols. No other brand or substitute will meet the Government’s needs.