digene HC2 GC-ID DNA Test
For detection of Neisseria gonorrhoeae (GC) infections
The digene HC2 GC-ID DNA Test is an in vitro microplate assay based on signal-amplified nucleic acid hybridization that uses chemiluminescence for the qualitative detection of Neisseria gonorrhoeae (GC) DNA from cervical specimens.
The digene HC2 GC-ID DNA Test is intended for in vitro diagnostic use.
The digene HC2 GC-ID DNA Test provides high clinical sensitivity and specificity (see table).
The digene HC2 GC-ID DNA Test is a nucleic acid hybridization assay with signal amplification that utilizes microplate chemiluminescent detection.
Specimens that contain the target DNA are hybridized with a specific GC RNA probe cocktail. The resultant RNA–DNA hybrids are captured onto the surface of a microplate well that is coated with antibodies specific for RNA–DNA hybrids. The immobilized hybrids are then reacted with alkaline phosphatase-conjugated antibodies that are specific for RNA–DNA hybrids, and are 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 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).
The digene HC2 GC-ID DNA Test is for separate qualitative detection of Neisseria gonorrhoeae (GC) DNA in cervical specimens. The test can be used as a standalone test or as a follow-up test for detection of GC in specimens that were initially positive using the digene HC2 CT/GC DNA Test. The digene HC2 GC-ID DNA Test is indicated for use to identify symptomatic or asymptomatic women with Neisseria gonorrhoeae (GC) infection.
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