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.
The Hybrid Capture Modular System provides a microplate luminometer, rotary shaker, microplate heater, automated plate washer, and the Hybrid Capture Multi-Specimen Tube (MST) Vortexter that may be used for processing specimens using the digene HC2 CT/GC DNA Test.
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 CT/GC DNA Test is recognized by the American Medical Association (AMA) and reimbursed using "amplified probe technique" CPT codes (when appropriate).