Infectious Diseases

Rapidly mutating HIV-1 virus can evade quantification with a single target viral load assay. cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems targets two unique regions of the HIV-1 genome, gag and LTR, which are not subject to selective drug pressure. This approach improves test sensitivity, coverage and security in the event of mutation in one primer/probe region.

• Targeting two regions improves genotype inclusivity, detects HIV-1 variants and potentially avoids under quantification.

• Accurate quantification of HIV-1 RNA with a dual target assay contributes to optimal treatment decisions for patient management.

cobas® HIV-1 is an in vitro nucleic acid amplification test for the quantitation of HIV-1 in EDTA plasma of HIV-1-infected individuals. This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1-infected patients. This test can be used for confirmation of HIV-1 infection in antibody reactive individuals and to assess patient prognosis by measuring the baseline HIV-1 level or to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of antiretroviral treatment.

HCV – an ever-changing virus
The combination of error-prone RNA replication with a high rate of virus production results in extreme genetic variability of hepatitis C virus (HCV). A quantitative HCV RNA test must therefore be able to tolerate sequence mismatches for accurate and reliable results.

cobas® HCV accurately detects and quantifies all HCV genotypes 1 through 6

• Two non-overlapping detection probes, when combined with two staggered primers, ensure assay performance with HCV isolates containing sequence heterogeneity.

• Mismatch tolerance that enables the test to accurately quantify the target despite nucleotide changes in the viral genome while maintaining high specificity for HCV RNA.

Clinicians rely on regular HCV viral load assessment to achieve an optimal treatment outcome. Depending on the treatment regimen, HCV RNA measurements are made at baseline to identify likely treatment responders, to assess patient adherence during therapy, to determine if the treatment should be abbreviated or abandoned (futility rules) or that treatment has been successful and sustained virological response (SVR) has been achieved.

cobas® HCV delivers:

• Tight precision at medically-relevant decision points

• Accurate detection and quantification of HCV genotypes 1 through 6

• High sensitivity suitable for use with new HCV therapies

• Excellent correlation with the cobas® AmpliPrep/cobas® TaqMan® HCV Quantitative Test, v2.

Furthermore, cobas® HCV is approved as an aid in the diagnosis of HCV to confirm active infection in individuals with HCV antibody evidence.

cobas® HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV-infected individuals. Specimens containing HCV genotype 1 to 6 are validated for detection and quantitation in the assay.

The test is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.

The test is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. The results must be interpreted within the context of all relevant clinical and laboratory findings.

• Broad coverage of all known HBV genotypes (A-H) including pre-core mutations

• Tight precision at medically relevant decision points

• Excellent performance with serum and plasma specimens

• Built-in contamination control with AmpErase enzyme to prevent carryover contamination

• Excellent correlation to Roche COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 

cobas®  HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human EDTA plasma or serum of HBV-infected individuals. This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas® HBV must be interpreted within the context of all relevant clinical and laboratory findings.

• Standardisation: Traceable to the 1st WHO International Standard for Cytomegalovirus (NIBSC 09/162) Results reported in IU/mL, Consistent and reliable results across the linear range.
  Enable result comparison across institutions to support standardisation efforts.

• Clinical validation: Extensive studies conducted during development to demonstrate analytical performance, External clinical studies performed demonstrating correlation between the cobas®4800/6800/8800 Systems.
  Help to minimise the need for extensive QC and validation.

• Workflow efficiency: Full automation to minimize hands-on time, Ready-to-use reagents and controls, Calibration performed by Roche.
  Allow for more time to be spent on revenue generated activities for the lab.

cobas® CMV is an in-vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (CMV) DNA in human EDTA plasma. cobas® CMV is intended for use as an aid in the diagnosis and management of CMV in solid organ transplant patients and in hematopoietic stem cell transplant patients. The test can be used in these populations to assess the need to initiate antiviral treatment. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment. The results from cobas® CMV must be interpreted within the context of all relevant clinical and laboratory findings.

• Standardization – Results traceable to the WHO International Standard and reporting in IU/mL for improved harmonization in testing results across hospitals and institutions

• State-of-the-art design – Best-in-class performance with dual target assay design to provide reliable and reproducible results for reassurance in clinical decision making

• Efficiency, flexibility and simplicity – Ability to perform critical transplant testing (CMV, EBV, BKV) from a single sample on the cobas® 6800/8800 Systems with an industry-leading menu, absolute automation and proven performance.

• Enabling BKV urine testing the right way - Urine sample stabilized in cobas® PCR media allows result integrity to be maintained, enabling faster preparation and making storage and transportation more convenient without the need of refrigeration

cobas® EBV is an in vitro nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA in human EDTA plasma on the cobas® 6800/8800 Systems. cobas® EBV is intended for use as an aid in the management of EBV in transplant patients. In patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess response to treatment.

cobas® BKV is an in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human EDTA plasma and urine stabilized in cobas® PCR Media on the cobas® 6800/8800 Systems. In EDTA plasma, cobas® BKV is intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV in EDTA plasma, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. In urine stabilized in cobas® PCR Media, cobas® BKV is intended for use as an aid in the management of BKV in transplant patients.