Infectious Diseases: Systems and assays

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Our increasingly connected world enables the rapid spread of infectious diseases, requiring rapid and accurate surveillance and monitoring. Roche Molecular Diagnostics offers a broad range of assays to detect and quantify viral and bacterial pathogens, in both single and multiplex formats.




cobas® 6800/8800

Own the future

Integrated, fully automated molecular testing platforms available in medium and high-throughput models designed for blood screening, viral load monitoring, women’s health, and microbiology testing.

As molecular testing evolves, so can you.

Features and Benefits

Unparalleled Performance

Rapidly complete daily testing requirements with the highest throughput available and the fastest time to results.

  • Process up to 384 (cobas® 6800) and 960 (cobas® 8800) tests in an 8-hour shift.*
  • Up to 96 test results are available in less than 3.5 hours*, with an additional 96 results available every 90 minutes thereafter for cobas® 6800 and every 30 minutes thereafter for cobas® 8800

Absolute Automation

Minimal and intuitive interactions with the systems provide users with eight (cobas® 6800) and four hours (cobas® 8800) of “work-away” time* while also reducing the potential for human error.

  • Ready-to-use reagents ensure no thawing, mixing or pouring
  • Improves productivity with onboard storage and refrigeration system maintaining inventory of consumables and reagents
  • Radio-frequency identification (RFID) and barcodes ensure full traceability, eliminating the need for manual records

Unmatched Flexibility

Run the tests you want when you want without the need for further user interactions.

  • Perform up to 3 tests in the same run without presorting or batching
  • Optimize sample utilization by processing up to 3 different tests from the menu using a single patient sample
  • Quickly and easily handle high-priority samples with the dedicated priority lane
  • Consolidated and expanding menu to meet your needs today and tomorrow

The portfolio includes the cobas® 6800/8800 systems; the cobas p 680 instrument to support the creation of donor sample pools; three next-generation assays for viral load testing: cobas® HIV-1, cobas® HCV; and cobas® CMV plus two next-generation assays for donor screening: cobas® MPX, cobas® WNV. 

*May vary based on workflow demands.

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Molecular research continues to inspire diagnostic insights, and Roche works to translate these insights into difference-making applications.

Our comprehensive menu of diagnostic and research assays deliver accurate, reliable results each and every time. Explore our growing portfolio of assays and continue to trust your research to Roche.

For use on the cobas® 6800/8800 System

  • cobas® HIV
  • cobas® HCV
  • cobas® CMV for use on the cobas® 6800/8800 Systems


cobas® HIV-1 for use on the cobas® 6800/8800 System

Stay one step ahead. It takes more than just a single target.

As the challenges you face evolve, stay one step ahead with the next generation quantitative HIV-1 assay with a dual target approach.

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® 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.


Features and Benefits

  • 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.

Intended Use

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.


cobas® HCV for use on the cobas® 6800/8000 System

See what truly matters

cobas® HCV, quantitative nucleic acid test for use on the cobas® 6800/8000 system, delivers robust, clinically relevant assay performance based on the proprietary dual-probe assay design from Roche with built-in redundancy for broad genotype coverage and improved mismatch tolerance to ensure confidence in viral load monitoring. cobas® HCV is designed to deliver high sensitivity to meet the requirements of current and future chronic hepatitis C therapies combined with an efficient workflow for laboratories.

Features and Benefits

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.

Clinical Relevance

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.

Intended Use

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.


cobas® CMV Setting the Standard in Monitoring CMV Infection

Cytomegalovirus (CMV) is a leading cause of morbidity and mortality in transplant recipients. Severe CMV infection in high risk patients may occur soon after transplantation. Without effective treatment, patients may develop CMV syndrome, tissue invasive disease, and potential rejection or loss of the graft.

The cobas® CMV quantitative nucleic acid test for use on the cobas® 6800/8800 Systems reliably monitors infection in patients receiving antiviral therapy.

Assay Benefits

Traceability to the WHO Standard – cobas® CMV is traceable to the first WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162) providing consistent, reliable results across the dynamic range of the assay and across institutions.

Proven advantages over lab developed tests – cobas® CMV eliminates the need to perform complex LDTs, providing quality control and quality assurance of reagents and validated results.

Reassurance in clinical decision making – cobas® CMV standardized viral load testing enables a common strategy to be developed in the management of CMV infection in transplant patients.

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