Qiagen, 5130-1220, digene HC2 CT/GC DNA Test

digene HC2 CTGC DNA Test

Features

- High clinical sensitivity and specificity
- Signal-amplified nucleic acid test with immunoassay simplicity
- Detects both symptomatic and asymptomatic CT and GC infections

Product Details

The digene HC2CT/GC DNA Test is an in vitro nucleic microplate assay based on signal-amplified nucleic acid hybridization that uses chemiluminescence for the combined qualitative detection of DNA from Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) from cervical specimens. The kit is for labs that perform in vitro diagnostic tests.

Performance

Initial HC2 CT/GC DNA Test: Repeat HC2 CT-ID DNA Test
+: +
+: –
–: +
–: –
–: NA

The digene HC2 CT/GC DNA Test provides combined qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) DNA as an initial test to identify symptomatic or asymptomatic women with CT and/or GC infection. Follow-up testing with the digene HC2 CT-ID DNA Test and the digene HC2 GC-ID DNA Test is required to identify the organism(s) present in a specimen that tests postive with the digene HC2 CT/GC DNA Test (see table). For high-volume sample throughput testing, the digene HC2 CT/GC DNA Test may be performed using the Rapid Capture System (RCS) instrument.

Procedure

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. >

Reimbursement

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). >

Applications

The digene HC2 CT/GC DNA Test is for the combined qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) DNA in cervical specimens. Follow-up testing using the digene HC2 CT-ID DNA Test and the digene HC2 GC-ID DNA Test is required to identify the organism(s) present in specimens that test positive with the digene HC2 CT/GC DNA Test. The digene HC2 CT/GC DNA Test is indicated for use as an initial test to identify symptomatic or asymptomatic women with Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) infection.