For in vitro diagnostic use. Others UC-DGN-ADV IVD IVD UC-TIB-AdV RMD-UC-001 Real time PCR kit for quantification of human Adenovirus.For use with the cobas® omni utility channel on the cobas® 6800/8800 Systems. 09838872001 UC-TIB-AdV UC-TIB-AdV 04260159334876 Reagents, kits 1 kit 192 tests false UC-TIB-AdV is an automated in vitro nucleic acid amplification test for the detection and quantification of human Adenovirus (AdV) DNA in human EDTA plasma samples. This test is intended to be used with the UC-TIB-AdV USAP (utility channel Specific Analysis Package) on 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 ADV infections and for monitoring AdV DNA levels such as in transplanted and immunocompromised patients. The results from UC-TIB-AdV must be interpreted within the context of all relevant clinical and laboratory findings. en The AdV detection is performed on the cobas® 6800/8800 Systems with the UC-TIB-AdV on human EDTA plasma samples. The viral load is quantified with an AdV standard curve calibrated using the World Health Organization (WHO) international standard. In addition, the test utilizes two external controls: a Positive Control provided in this kit and a Negative Control (Roche P/N 09051953190).The UC-TIB-AdV 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-AdV works with the optimal conditions (defined parameters from sample preparation to result analysis) included in the USAP. The UC-TIB-AdV 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-AdV.Nucleic acid from patient samples, external controls (Positive and Negative) and the added internal control are extracted simultaneously. The four standard curve points are processed in the same way in order to measure the quantification of each sample. 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-AdV contains the AdV 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, the positive control and the 4 Standard Curve Points is achieved by the use of target virus-specific forward and reverse primers which are selected from conserved regions of the AdV hexon gene.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 AdV genomes. A thermostable DNA polymerase enzyme is used for amplification. The target and 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 mix.The probes are labeled with target-specific fluorescent reporter dyes allowing simultaneous detection of the AdV target and IC in two different 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.The quantification of AdV DNA is ensured by the four AdV standards (STD1, STD2, STD3 and STD4) provided in the UC-TIB-AdV. AdV standards quantified in International Unit per milliliter are used for calibration of the assay and are processed as patient samples on the cobas® 6800/8800 Systems. Data management is performed by the cobas® omni utility channel Optimization Tool software used in combination with the UC-TIB-AdV Offline Quantification Tool which assigns test results for all tests as either target not detected, AdV DNA detected < LLoQ (lower limit of quantification), AdV DNA detected > ULoQ (upper limit of quantification), or a value in the linear range LLoQ < x < ULoQ. Results of the UC-TIB-AdV Offline Quantification Tool can be printed as a report. en