For in vitro diagnostic use. Others UC-DGN-HSV VZV IVD IVD UC-TIB-HSV/VZV RMD-UC-002 Real time PCR kit for qualitative detection of human Herpes Simplex Virus 1/2 and Varicella Zoster Virus.For use with the cobas® omni utility channel on the cobas® 6800/8800 Systems. 09838902001 UC-TIB-HSV/VZV UC-TIB-HSV/VZV 04260159334869 Reagents, kits 1 kit 192 tests false UC-TIB-HSV/VZV is an automated in vitro nucleic acid amplification test for the qualitative detection of human Herpes Simplex Virus-1 (HSV-1), Herpes Simplex Virus-2 (HSV-2) and Varicella Zoster Virus (VZV) DNA in human EDTA plasma samples. This test utilizes the open channel functionality (cobas® omni utility channel) of the cobas® 6800/8800 Systems.This test is intended for use as an aid in the diagnosis of human HSV and VZV infections such as in transplanted and immunocompromised patients.The results from UC-TIB-HSV/VZV must be interpreted within the context of all relevant clinical and laboratory findings. en The HSV/VZV detection is performed on the cobas® 6800/8800 Systems with the UC-TIB-HSV/VZV on human EDTA plasma samples. The test utilizes two external controls: a Positive Control provided in this kit and a Negative Control (Roche P/N 09051953190).The UC-TIB-HSV/VZV used in combination 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 UC-TIB-HSV/VZV works with the optimal conditions (defined parameters from sample preparation to result analysis) included in the USAP (utility channel Specific Analysis Package). The UC-TIB-HSV/VZV is assigned to the cobas® omni Utilily Channel 192 Reagent Kit (192-test cassette) and then transferred to the cobas® 6800/8800 Systems in order to perform the UC-TIB-HSV/VZV.Nucleic acid from patient samples, external controls (Positive and Negative) and the added internal control is extracted simultaneously. Nucleic acid is released by addition of proteinase and lysis reagent to the sample and the released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cell debris and potential PCR inhibitors are removed with subsequent wash reagent steps and purified nucleic acid is eluted from the glass particles with elution buffer at elevated temperature.The UC-TIB-HSV/VZV contains the HSV-1, HSV-2 and VZV 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 provided by Roche. 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 HSV-1 (UL5), HSV-2 (UL30) and VZV (ORF-31) genes.The 192-test cassette contains an internal control (IC) recognized by specific primers and probes included in the cobas® omni utility channel Master Mix Reagent 2 (UC MMX-R2). Selective amplification of the IC is achieved by the use of sequence-specific forward and reverse primers which have no homology with the HSV and VZV genomes. A thermostable DNA polymerase enzyme is used for amplification. The target and internal control 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 mix.The probes are labeled with target-specific fluorescent reporter dyes allowing simultaneous detection and differentiation of the HSV-1, HSV-2 and VZV targets, and internal control in four target channels. The fluorescent signal of the intact probes is suppressed by the quencher dye. During the PCR amplification step, hybridization of the probe with the specific single-stranded DNA templates results in cleavage by the 5'-to-3' nuclease 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 is concomitantly increased. Real-time detection and discrimination of PCR products is accomplished by measuring the fluorescence of the released reporter dyes for the viral targets and IC. en