For in vitro diagnostic use. Others cobas BV/CV 5800-6800-8800 IVD cobas® BV/CV PID00001231 For use on the cobas® 5800/6800/8800 systems 09 988 815 190 9 988 815 190 09988815190 9988815190 09988815190 KIT COBAS 5800/6800/8800 BV/CV 192T IVD KIT COBAS 5800/6800/8800 BV/CV 192T IVD 00875197007497 Reagents, kits 1 kit 192 tests true cobas® BV/CV for use on the cobas® 5800/6800/8800 systems is an automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of bacteria (Gardnerella vaginalis, Lactobacillus spp., and Atopobium vaginae) associated with bacterial vaginosis (BV) and yeast (Candida spp.) associated with candida vaginitis (CV) from clinician-instructed self-collected vaginal swab specimens and clinician-collected vaginal swab specimens, all collected in cobas® PCR Media. The assay amplifies specific DNA targets to detect organisms associated with BV (i.e., G. vaginalis, L. crispatus, L. gasseri, L. jensenii, and A. vaginae) and specific organisms associated with CV (i.e., C. albicans, C. dubliniensis, C. glabrata, C. krusei, C. tropicalis, and C. parapsilosis) but does not differentiate which BV and/or CV organism(s) is present. This test is intended as an aid in the diagnosis of BV and/or CV in symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both. en cobas® BV/CV is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800 system is designed as one integrated instrument. The cobas® 6800/8800 systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 5800 system or cobas® 6800/8800 systems software which assigns test results for all tests as positive, negative or invalid. Results can be reviewed directly on the system screen, exported, or printed as a report. Nucleic acid from patient samples and added internal control DNA (DNA-IC) molecules are simultaneously extracted. In summary, nucleic acid is released by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors, are removed with subsequent wash steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature. External controls (positive and negative) are processed in the same way. Selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers for the bacteria and yeast associated with BV and CV which are selected from highly conserved regions within the respective target organism (CV: Candida species, BV: Gardnerella vaginalis, Atopobium vaginae, and Lactobacillus species). The bacteria and yeast associated with BV and CV, respectively, are detected by multiple sets of primers and probes. Selective amplification of DNA IC is achieved by the use of sequence-specific forward and reverse primers which are selected to have no homology with any target regions for the bacteria and yeast associated with BV and CV. A thermostable DNA polymerase enzyme is used for PCR amplification. The target and DNA-IC sequences are amplified simultaneously utilizing a universal PCR amplification profile with predefined temperature steps and number of cycles. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon). Any contaminating amplicon from previous PCR runs is eliminated by the AmpErase enzyme, which is included in the PCR master mix, during the first thermal cycling step. However, newly formed amplicons are not eliminated since the AmpErase enzyme is inactivated once exposed to temperatures above 55°. The cobas® BV/CV master mix contains multiple probes specific for the CV associated target sequences, multiple probes specific for the BV associated target sequences and one for the DNA-IC. The probes are labeled with target specific fluorescent reporter dyes allowing simultaneous detection of CV associated targets, BV associated targets and DNA-IC in five different target channels. When not bound to the target sequence, the fluorescent signal of the intact probes is suppressed by a quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5' to 3' exonuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye increases concomitantly. Real-time detection and discrimination of PCR products is accomplished by measuring the fluorescence of the released reporter dyes for the BV and CV associated targets and DNA-IC, respectively. en

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