For in vitro diagnostic use. Others cobas Paraflu 1-4 UC IVD cobas® Paraflu 1-4 UC PID00000040 Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems 09555617190 KIT COBAS 6800/8800 UC PARAFLU 1-4 192T cobas UC Paraflu 1-4 00875197007008 Reagents, kits 1 kit 192 test false The cobas® Paraflu 1-4 UC Qualitative Nucleic Acid test for use with the cobas omni Utility Channel on cobas® 6800/8800 Systems is an automated, multiplex, real-time reverse transcriptase polymerase chain reaction (PCR)  for the timely in vitro qualitative detection and discrimination of human Parainfluenza virus serotypes 1, 2, 3, and 4 (HPIV1-4). This test is intended for use as an aid in the diagnosis of HPIV1-4 in nasopharyngeal swab specimens from patients with signs and symptoms of a respiratory infection in conjunction with clinical and epidemiological risk factors. The results from cobas® Paraflu 1-4 UC must be interpreted within the context of all relevant clinical and laboratory findings. Negative results do not preclude viral 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® Paraflu 1-4 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® Paraflu 1-4 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 RNA Internal Control (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 reagent 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® Paraflu 1-4 UC run. cobas® Paraflu 1-4 UC contains the HPIV1-4 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 target nucleic acid from the sample, and the positive control is achieved by the use of target virus- specific forward and reverse primers which are selected from conserved regions of the HPIV1 (L polymerase protein), HPIV2 (Large protein), HPIV3 (Nucleocapsid protein) and HPIV4 (Large protein) genes.  Selective amplification of the  RNA  Internal Control  is achieved by the use of non-competitive sequence specific forward and reverse primers,  which have no  homology with the HPIV1-4 genomes. Amplified target is detected by cleavage of fluorescently labeled oligonucleotide  probe. A thermostable DNA polymerase enzyme is used for amplification. The prepared cobas® Paraflu 1-4 UC master mix contains detection probes which are specific for human parainfluenza viruses 1-4 and the RNA Internal Control nucleic acid. HPIV1-4 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