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The Digene HCII CT/GC Test is an in vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the combined qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) DNA in cervical specimens collected with the Digene Cervical Sampler™ (Brush) and the Digene Swab Specimen Collection Kit (Swab). Follow-up testing using the Digene HCII CT-ID and HCII GC-ID Tests is required to identify the organism(s) present in HCII CT/GC DNA Test positive specimens. The HCII 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. For In Vitro Diagnostic Use.

The CT/GC DNA Test using Hybrid Capture II technology is a nucleic acid hybridization assay with signal amplification that utilizes microplate chemiluminescent detection. Specimens containing the target DNA hybridize with a specific CT/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 enhancement. As the substrate is cleaved by the bound alkaline phosphatase, light 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. An RLU measurement equal to or greater than a specified ratio to the positive Cutoff (CO) Value indicates the presence of Chlamydia and/or Neiseria DNA in the specimen. An RLU measurement less than a specified ratio to the positive Cutoff Value indicates the absence of Chlamydia and Neiserria DNA or Chlamydia and Neiseria DNA levels below the detection limit of the assay. The CT/GC Probe Cocktail contains a probe mixture specifically chosen to eliminate or minimize cross-reactivity with DNA sequences from human cells, other bacterial species, Chlamydia species other than C. trachomatis or Neisseria species other than N. gonorrhoeae. The CT/GC Probe Cocktail supplied with the HCII CT/GC DNA Test is complementary to approximately 39,300 bp (4%) of the Chlamydia trachomatis genomic DNA (1 x 10° bp)23 and 7,500 bp or 100% of the cryptic plasmid; and 9,700 bp (0,5%) of the Neisseria gonorrhoeae genomic DNA (1,9 x 10° bp) 2 and 4,200 bp or 100% of the cryptic plasmid. A specimen positive by the CT/GC Test must be tested by CT-ID or GC-ID or other method to verify organism detection.

The Digene HCII GC-ID Test is a nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of N. gonorrhoeae DNA in cervical specimens collected using the Digene Cervical Sampler™ (Digene cervical brush and Digene Specimen Transport Medium) and in cervical specimens collected using the Digene Swab Specimen Collection Kit ([Swab SCK] Dacron® swab and Digene Specimen Transport Medium). The Digene HCII GC-ID Test is indicated for use as an aid in diagnosing infection with N. gonorrhoeae in symptomatic or asymptomatic females. The HCII GC-ID Test may be used alone or as a supplemental test to the Digene HCII CT/GC Test to detect N. gonorrhoeae in specimens that are positive by the HCII CT/GC Test.

The Digene GC-ID Test using Hybrid Capture II technology is a nucleic acid hybridization assay with signal amplification that utilizes microplate chemiluminescent detection. Specimens containing the target DNA hybridize with a specific 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. An RLU measurement equal to or greater than the Cutoff Value indicates the presence of GC DNA in the specimen. An RLU measurement less than the Cutoff Value indicates the absence of GC DNA or GC DNA levels below the detection limit of the assay. The GC Probe Cocktail contains a probe mixture specifically chosen to eliminate or minimize cross-reactivity with DNA sequences from human cells, other bacterial species, or Neisseria species other than gonorrhoeae. The GC Probe Cocktail supplied with the Digene GC-JD Test is complementary to approximately 9,700 bp or 0.5% of the Neisseria gonorrhoeae genomic DNA (1.9 x 108 bp) . One probe is complementary to 100% of the cryptic plasmid of 4,200 bp.

The Digene HCII CT-ID Test is an in-vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of C trachomatis DNA in cervical specimens collected using the Digene Cervical Sampler™ (Cervical Brush and Speciment Transport Medium) and in cervical specimens collected using the Digene Swab Specimen Collection Kit (Dacron Swab and Speciment Transport Medium). The Digene HCII CT-ID Test is indicated for use with symptomatic or asymptomatic women as evidence of infection with C. trachomatis. The HCII CT-ID Test may be used alone or as a supplemental test to the Digene HCII CT/GC Test to detect C. trachomatis DNA in specimens found positive by the Digene HCII CT/GC Test.

The Digene HCII CT-ID Test is a nucleic acid, signal enhanced, hybridization, microplate assay using chemiluminescence for the qualitative detection of C. trachomatis (CT) DNA in cervical specimens collected using the Digene Cervical Sampler™ and in cervical specimens collected with a Dacron swab and placed in Digene Specimen Transport Medium. The Digene HCII CT-ID Test is indicated for use as an aid in diagnosing infection with C. trachomatis in symptomatic or asymptomatic women. The HCII CT-ID Test may be used as a stand-alone test or may be used as a supplemental test to the Digene HCII CT/GC Test for identification of C. trachomatis in specimens that are positive by the HCII CT/GC Test. Specimens potentially containing CT DNA are denatured and then hybridized with a specific RNA probe cocktail. This cocktail contains a probe mixture chosen to minimize or eliminate cross-reactivity with DNA sequences from human cells, other bacterial species, Chlamydia species other than trachomatis, or sequences from other organisms common in urogenital specimens. The CT probe cocktail supplied with the Digene CT-ID Assay is complementary to approximately 39,300 base pairs or 4% of the C. trachomatis genome (1 x 10 base pairs) and 100% of the cryptic plasmid. The RNA:DNA hybrids resulting from hybridization are immobilized (captured) on the surface of a microplate-well, which has been coated with antibodies specific for RNA:DNA hybrids. The antibodies on the well surface capture the RNA:DNA hybrids. The immobilized hybrids are then reacted with alkaline phosphatase-conjugated antibody and a chemiluminescent substrate. As the substrate is cleaved by the bound alkaline phosphatase, photons are emitted and measured as Relative Light Units (RLUs) using a standard, FDA-cleared luminometer such as the DML 2000™ - Increased photon emission, resulting in an enhanced signal, is achieved by conjugating multiple alkaline phosphatase molecules to each antibody molecule. Multiple antibodies bind to each RNA:DNA hybrid, further enhancing the signal. The HCII CT-ID Test provides an RLU measurement that is qualitatively interpreted. The Positive Cutoff Value is equal to the mean of three Positive Control values. Each specimen RLU measurement is converted to a ratio of the Positive Cutoff Value. This conversion calculation is performed automatically by the Digene DML™ 2000 Microplate Luminometer software. Alternatively, the conversion may be calculated manually, Specimens with RLU/Cutoff values of < 0.8 are considered negative for CT DNA. Specimens with RLU/Cutoff values >5.0 are considered positive for CT DNA. Specimens with RLU/Cutoff values between 0.8 ≥ 5.0 are considered to be equivocal and are repeat tested in duplicate. With the repeat tests, a RLU/Cutoff Value of 1.0 is applied. If two of the three replicates fall above 1.0, the presence of C. trachomatis DNA is indicated. If at least two of the three replicates fall below 1.0, the presence of C. trachomatis DNA is not indicated.

The Digene Hybrid Capture® CMV DNA Assay is a qualitative, in vitro, diagnostic assay intended for the detection of human cytomegalovirus (CMV) DNA in human peripheral white blood cells isolated from whole blood specimens collected in EDTA. It is indicated for use as an aid in diagnosing CMV infection in solid organ transplant, bone marrow transplant and HIV/AIDS patients. This assay has not been cleared by the FDA for blood/plasma donor screening.

The Hybrid Capture® CMV DNA Assay is a qualitative in vitro diagnostic assay. It is a nucleic acid, signal enhanced, solution hybridization, antibody capture assay that uses chemiluminescent signaling to detect CMV DNA. The assay kit consists of 13 reagents and two accessories. Whole blood specimens are treated with an agent that lyses red blood cells, and the specimen is centrifuged, resulting in a pellet of white blood cells. The white blood cell pellet is then used in the Hybrid Capture CMV DNA Assay. Specimens potentially containing CMV DNA are denatured and then hybridized with a specific CMV RNA probe cocktail. This cocktail contains a probe mixture chosen to eliminate cross-reactivity with human or other herpesvirus sequences. The CMV probe supplied with the Hybrid Capture CMV DNA Assay is complementary to approximately 40,000 base pairs or 17% of the CMV genome (230,000 base pairs). The RNA:DNA hybrids resulting from hybridization are captured on the surface of a tube coated with affinity-purified polyclonal caprine antibodies specific for RNA:DNA hybrids. The immobilized hybrids are then reacted with alkaline phosphatase-conjugated, murine monoclonal antibody to 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 signal enhancement. As the substrate is cleaved by the bound alkaline phosphatase, light is emitted and is measured in Relative Light Units (RLUs) on a standard commercial luminometer. The RLU value of a specimen is compared to a Positive Cutoff Value and to an Equivocal Cutoff Value to determine if the specimen is positive, equivocal, or negative for the presence of CMV DNA.

The Digene DML 2000 Microplate Luminometer is intended to measure light that is emitted as a result of a chemiluminescent reaction. Assay results obtained using chemiluminescence technology in 96 well microplates are calculated and interpreted according to assay validation parameters.

The DML 2000 is a microplate luminometer capable of reading chemiluminescence from opaque microplates. Chemiluminescence is the production of light from a chemical reaction. The luminometer is optimally designed for measurement of glow type luminescence. The luminometer is designed to be run and controlled by a personal computer connected via a serial RS-232 interface port. The instrument is simple in design with measurement taking place in 96-well microplates, where each well is presented to the detector by stepper motors moving the plate. The light is detected by a photomultiplier tube. The light is amplified and converted to an electrical signal which is detected by a sensitive electrical amplifier. The detected signals are converted to Relative Light Units (RLU) and are reported for each well of the microplate. Assay results are calculated and interpreted according to assay validation parameters.

The Digene Cervical Brush is intended for the collection of cervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing.

The Digene Cervical Brush has a truncated cone-shaped brush head composed of bristles joined to a wire shaft; the brush head on the wire shaft is bonded to a plastic handle. The distal end of the wire shaft is embedded in solidified glue. To collect cervical cells, the brush end of the Digene Cervical Brush is inserted 1.0 to 1.5 cm into the cervical os until the longest outer bristles of the brush touch the ectocervix. The brush is rotated three full turns in a counter-clockwise direction and withdrawn. The brush is then used to spread the specimen onto a glass slide for a Pap smear or is inserted into a transport tube for use in STD testing.