On Mar. 17, 1999, the Hybrid Capture II human papillomavirus (HPV) DNA test was approved by the U.S. Food and Drug Administration (FDA) as a test that can be used in conjunction with the Pap smear in screening for cervical cancer. The device, as modified, was marketed under the trade name Digene HPV Test Using Hybrid Capture(R) II Technology (HCII HPV).

Approval for chaning the solid phase on which the RNA:DNA hybrids are captured from polystyrene tubes to a 96-well microtiter place addition of a new cervical specimen collection kit (Digene Cervical Sampler), addition of the Digene Sample Conversion Kit, and the addition of new assay performance characteristics.

The Digene HPV Test using Hybrid Capture II technology is a nucleic acid signal enhanced solution hybridization microplate assay using chemiluminescence for the qualitative detection of eighteen types of human papillomavirus (HPV) DNA in cervical specimens.