“…We did not directly assess consumer understanding instructions and/or demonstration of nasal swab collection and results interpretation. Instead, consistent with previously conducted studies, 23 , 29 , 30 , 31 , 37 we used established health literacy assessment tools (i.e., FRE, F–H, UFT, SAM, PEMAT-A/V) to gauge likelihood of consumer understanding and proper use of OTC rapid antigen COVID-19 tests. Direct assessment of patient/consumer comprehension of instructions—semi-structured interviews and/or focus groups—could potentially pinpoint content areas and formatting characteristics in need of refinement as future OTC COVID-19 test instructions are developed.…”