digene HC2 CT–GC Dual ID DNA Test

The digene HC2 CT-GC Dual ID DNA Test provides high clinical sensitivity and specificity, comparable to more complex target-amplification methods (see tables).

High clinical sensitivity and specificity — CT testing

The digene HC2 CT-ID DNA Test compared to culture and DFA.

Method	Sensitivity	Specificity
Brush	97.7%	98.2%
Swab	92.3%	98.6%

High clinical sensitivity and specificity — GC testing

The digene HC2 GC-ID DNA Test compared to culture.

Method	Sensitivity	Specificity
Brush	92.6%	98.5%
Swab	95.2%	98.9%

Reimbursement

The digene HC2 CT-GC Dual ID DNA Test is recognized by the American Medical Association (AMA) and reimbursed using "amplified probe technique" CPT codes (when appropriate).

The digene HC2 CT-GC Dual ID DNA Test is a nucleic acid hybridization assay with signal amplification that utilizes microplate chemiluminescent detection. Specimens containing the target DNA hybridize with a specific CT or GC RNA probe cocktail. The resultant RNA–DNA hybrids are captured onto the surface of a microplate well coated with antibodies specific for RNA–DNA hybrids. Immobilized hybrids are then reacted with alkaline phosphatase conjugated antibodies specific for RNA–DNA hybrids, and detected with a chemiluminescent substrate. Several alkaline phosphatase molecules are conjugated to each antibody. Multiple conjugated antibodies bind to each captured hybrid resulting in substantial signal amplification. As the substrate is cleaved by the bound alkaline phosphatase, light is emitted, which is measured as relative light units (RLUs) on a luminometer. The intensity of the light emitted denotes the presence or absence of target DNA in the specimen.

The digene HC2 CT-GC Dual ID DNA Test kit contains the necessary probes and reagents to screen for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (GC), with an in vitro nucleic acid hybridization assay with signal amplification using chemiluminescence. The CT and GC probe cocktails contain probe mixtures specifically chosen to eliminate or minimize cross-reactivity with DNA sequences from human cells, other bacterial species, Chlamydia species other than Chlamydia trachomatis, or Neisseria species other than Neisseria gonorrhoeae. Cervical specimens for use with the digene HC2 CT-GC Dual ID DNA Test are collected and transported using the digene HC2 DNA Collection Device or digene Female Swab Specimen Collection Kit.

The digene HC2 CT-GC Dual ID DNA Test process is simple, from denaturation to hybridization and hybrid capture. After the final 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 Dual ID DNA Test is for separate qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) DNA in the same cervical specimen. The kit contains separate tests for CT and GC, which can be used as stand-alone tests. The tests may also be used as follow-up for differentiation of CT and GC in specimens that initially tested positive using the digene HC2 CT/GC DNA Test.

The digene HC2 CT-GC Dual ID DNA Test is indicated for use in identifying symptomatic or asymptomatic women with Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) infection.