For in vitro diagnostic use. Others cobas Influenza A B and RSV UC IVD cobas® Influenza A/B & RSV UC RMD-6800-8800-FABRUC Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems 09 233 962 190 9 233 962 190 09233962190 9233962190 09233962190 KIT C68/88 UC INFLUENZA A/B RSV 192T IVD cobas Influenza A/B and RSV UC 00875197006773 Reagents, kits 1 kit 192 tests false The cobas® Influenza A/B & RSV UC Qualitative Nucleic Acid test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems is an automated, multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) assay for the timely in vitro qualitative detection and discrimination of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the diagnosis and differentiation of influenza A, influenza B, and RSV in humans and is not intended to detect influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The cobas® Influenza A/B & RSV UC Qualitative Nucleic Acid test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems is intended for professional use in a clinical laboratory setting. en cobas® Influenza A/B & RSV UC for use with the cobas omni Utility Channel, is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. 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® 6800/8800 Systems software, which assigns test results for all tests. Results can be reviewed directly on the system screen, and printed as a report. Nucleic acid from patient samples and added internal control RNA (RNA IC) molecules are simultaneously extracted. 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 with each cobas® Influenza A/B & RSV UC run. cobas® Influenza A/B & RSV UC contains the influenza A, influenza B, and RSV primers and probes which are used in combination with the cobas omni Utility Channel Master Mix Reagent 2 (UC MMX-R2) and the 192-test cassette included in the cobas omni Utility Channel Reagent Kit. The 192-test cassette contains an internal control recognized by specific primers and probes included in the cobas omni Utility Channel Master Mix Reagent 2 (UC MMX-R2). Selective amplification of Influenza A and Influenza B target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers for the matrix proteins 1 and 2 (M1/M2) for influenza A and the nuclear export protein (NEP) / nonstructural protein 1(NS1) genes for influenza B, respectively. For RSV, selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers for the RSV matrix protein sequences. Selective amplification of RNA Internal Control is achieved by the use of non-competitive sequence specific forward and reverse primers which have no homology with the RSV or influenza genomes. Amplified target is detected by cleavage of fluorescently labeled oligonucleotide probe. A thermostable DNA polymerase enzyme is used for amplification. The prepared cobas® Influenza A/B & RSV UC master mix contains detection probes which are specific for influenza A virus, influenza B virus, RSV and the RNA Internal Control nucleic acid. Influenza A, influenza B, RSV and RNA Internal Control detection probes are each labeled with unique fluorescent dyes that act as a reporter. Each probe also has a second dye which acts as a quencher. When not bound to the target sequence, the fluorescent signals of the intact probes are suppressed by the 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. Each reporter dye is measured at defined wavelengths, which enables simultaneous detection and discrimination of the amplified target and the RNA Internal Control. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon). Any contaminating amplicons from previous PCR runs are destroyed by the AmpErase enzyme [uracil-N-glycosylase], which is included in the PCR mix, when heated in the first thermal cycling step. However, newly formed amplicons are not destroyed since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C. en

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