Comparison of the vaginal health assay for the detection of genotyped hrHPV in DNA extracted from 601 vaginal samples to that of the digene HC2 hrHPV assay.

The genotyping assay was considered positive if the normalized number of reads assigned to any of the validated hrHPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) divided by the number of reads assigned to a spike in control was greater than 0.1. The digene test was considered positive if the measured RLU was equal to or greater than the assay’s cutoff (RLU ratio of 1 or higher), as per the manufacturer’s instructions.