Test code links throughout this Guide refer to the corresponding test in the User's Guide. The Digene Hybrid Capture II System utilizes a specific HPV RNA probe cocktail to detect target DNA in patient specimens.
Hybridization is detected with a chemiluminescent substrate.
As the substrate is cleaved by the bound alkaline phosphatase, light is emitted. The intensity of light that is emitted denotes the presence or absence of target DNA in the specimen. Numerous investigations over the past several years have demonstrated that HPV is the factor most strongly and consistently associated with cervical cancer. A negative result does not rule out the presence of another HPV genotype not in the test panel, or one of the panel types missed because of low level infection or specimen sampling error. Clinicians can use the Hybrid Capture HPV DNA II Assay TM to triage patients who have equivocal Pap smears.