The fluorometry test showed that the DNA content exceeded the U.S. Food and Drug Administration (FDA) limits of 10 nanograms per dose by 188 to over 500 times. However, the qPCR test indicated that the DNA levels detected were below the regulatory standard.
Kevin McKernan, one of the study's authors with 20 years of experience in genomic sequencing who previously worked on the Human Genome Project and who is currently the chief scientific officer and founder of Medicinal Genomics, explained that the discrepancy in tests was because while fluorometry can detect double-stranded DNA of any size, qPCR can only detect DNA that has 100 base pairs or more.
However, while the qPCR tests rendered a result below regulatory standards, Mr. McKernan
explained previously that the FDA standards were published at a time when residual DNA in the vial would only be naked DNA that would have difficulty entering cells. This is different from the current mRNA vaccines; now, DNA can be packaged into lipid nanoparticles, transporting it directly into the cell.