The cervical specimens are collected and transported using the digene
HC2 DNA Collection Device or digene
Female Swab Specimen Collection Kit. Specimens are denatured using a denaturation reagent and heat. The probe mix is added, and hybridization is carried out in a hybridization microplate. Hybridized samples are transferred to a capture microplate for hybrid capture. A detection reagent is added, and a wash step is carried out. A second detection reagent is added, and detection is carried out on a luminometer.
After denaturation, the procedure can be fully automated on the Rapid Capture System through to sample detection. Detection is then carried out manually on a luminometer.
The digene HC2 GC-ID DNA Test is recognized by the American Medical Association (AMA) and reimbursed using "amplified probe technique" CPT codes (when appropriate).