Human Papilloma Virus (HPV)

This unique assay was developed by Genera Biosystems in collaboration with Healthscope Molecular.

The assay incorporates the following:

1. An initial amplification PCR step to increase the concentration of any viral DNA in the collected samples.
2. Using a set of highly specific probes bound to silica beads to hybridise with any "high risk" HPV types that may be present.
3. Detecting reacting beads and the type of HPV, using fluorescent activated cell sorting (FACS) technology.

This assay is able to detect one or more of the 13  HPV types that have been established as having oncogenic (high risk) potential. It will also detect the presence of types 6 and 11 that are commonly associated with genital/venereal warts and the presence of other (low risk) types of HPV (not reported to genotype level). In addition, the assay has internal controls that allow confirmation of adequate clinical material in the sample and that will also detect any substances inhibitory to the PCR step. These controls are both very important in preventing the reporting of potentially false negative results.

The assay is able to report the actual HPV genotype(s) detected rather than simply issue a broad statement such as "high risk type detected".