For in vitro diagnostic use. Others cobas HDV Test 5800-6800-8800 IVD cobas® HDV PID00001419 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems 09 900 152 190 9 900 152 190 09900152190 9900152190 09900152190 KIT COBAS 58/68/8800 HDV 192T IVD KIT COBAS 58/68/8800 HDV 192T IVD 00875197007411 Reagents, kits 1 kit 192 tests true cobas® HDV for use on the cobas® 5800/6800/8800 systems (cobas® HDV) is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis D virus (HDV) RNA in human EDTA plasma or serum of HDV antibody-positive or HDV-infected individuals. cobas® HDV is intended for use as an aid in the diagnosis of HDV infection in individuals suspected to be actively infected with HDV antibody evidence. Detection of HDV RNA indicates that the virus is replicating and therefore is evidence of active infection.cobas® HDV is intended for use as an aid in the management of patients with chronic HDV infection undergoing antiviral therapy. The test can be used to measure HDV RNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas® HDV must be interpreted within the context of all relevant clinical and laboratory findings.cobas® HDV is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 5800/6800/8800 systems. en cobas® HDV is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 5800/6800/8800 (x800) family of instruments includes three configurations with varying throughputs. The cobas® 6800/8800 systems are medium and high throughput configurations consisting of a sample supply module, the transfer module, the processing module, and the analytic module. The low throughput cobas® 5800 configuration incorporates all functions in one integrated instrument with a smaller footprint. Automated data management is performed by the instrument software, which assigns test results for all tests as target not detected, < LLoQ (lower limit of quantitation), > ULoQ (upper limit of quantitation) or HDV detected, a value in the linear range LLoQ < x < ULoQ. Results can be reviewed directly on the system screen and printed as a report.Nucleic acid from patient samples, external controls and added armored RNA (RNA-QS) molecules is simultaneously extracted. In summary, viral 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.Selective amplification of target nucleic acid HDV RNA from the sample is achieved by the use of organism-specific forward and reverse primers, which were selected to specifically hybridize to highly conserved regions of the HDV genome. The target and RNA-QS sequences are amplified simultaneously utilizing a universal PCR amplification profile with predefined temperature steps and number of cycles. A thermostable DNA polymerase enzyme is used for both reverse-transcription and amplification. 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. The cobas® HDV master mix contains detection probes which are specific for HDV and QS nucleic acid. The specific HDV and QS detection probes are each labeled with one of two unique fluorescent dyes which act as a reporter. Each probe also has a second dye which acts as a quencher. 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 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. Since the two specific reporter dyes are measured at defined wavelengths, simultaneous detection and discrimination of the amplified HDV RNA target and the QS are possible. en

cobas^® HDV

Quantitative nucleic acid test for use on the cobas^® 5800/6800/8800 systems

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