Patient-Specific Mrd Primers Amplify With Uniformly High Efficiency

The use of PCR to quantify MRD has been inhibited in North America owing to lack of insurance due to concern by the FDA that the amplification efficiency (AE) of patient-specific primers is unknown and the method is unstandardized. AE is conventionally derived from the slope of the regression line between Ct and the log of input, but the results of this technique are highly variable. Quantification of MRD by PCR is widely used in Europe and slopes corresponding to AE between 80% and 110% have been regarded as acceptable by the EuroMRD consortium.