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The Abbott RealTime CT/NG (List No. 8L07-91) assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens.

Abbott RealTime CT/NG consists of two reagent kits: - · Abbott RealTime CT/NG Amplification Reagent Kit (List No. 8L07-91) - · Abbott RealTime CT/NG Control Kit (List No. 8L07-80) The Abbott RealTime CT/NG assay uses PCR technology with homogenous real-time fluorescence detection on the m2000 System. The Abbott m2000 System consists of the Abbott m2000sp and Abbott m2000rt instruments. The Abbott m2000 System integrates sample preparation with nucleic acid amplification and detection to generate assay results. The Abbott m2000sp is used for processing samples and the Abbott m2000rt is used for amplification and detection.

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.