Development of the RealTime SARS-CoV-2 quantitative Laboratory Developed Test and correlation with viral culture as a measure of infectivity

•Modified FDA EUA qualitative RealTime SARS-CoV-2 assay into a quantitative LDT.•Analytical and clinical performance performed using nasopharyngeal swabs.•High linearity (R2 = 0.992) and high inter/intra-assay reproducibility seen across dynamic range.•Lower limit of detection was determined as 1.90 log10 copies/mL.•Ct < 29, corresponding to > 4.2 log10 copies/mL, correlated with ability to culture in Vero cells.