Complete confidence through proven performance

Striving for excellence, developing trust

Trust, an important foundation for healthcare systems, is built and maintained by many small interactions over time.

Roche’s long history of breakthrough innovations, benchmark performance, and consistent quality is the result of an unwavering commitment to scientific and clinical excellence in an ever-evolving global healthcare landscape. Roche customers around the world, from technicians to clinicians and the patients they serve, enjoy complete confidence in the proven performance of industry-leading instruments and assays.
 

A Roche Healthcare Consultant working with a lab director
Setting benchmarks for performance

As the leader in molecular diagnostics, Roche continually strives to set and advance the standard for infectious disease testing.

This begins with robust product testing. Prior to release, each instrument or assay is clinically validated with comprehensive studies conducted during development—including more than 250,000 collected data points for the 8 virology assays on cobas® 4800/6800/8800 Systems.1

Uncompromising adherence to the highest quality standards has elevated Roche to be the preferred partner for clinical trials around the world, with some assays being used to define and shape testing guidelines. Patients, clinicians, laboratories, and global health organizations recognize this industry-leading assay quality, and the WHO uses Roche’s HCV test as a reference for their prequalification process.1

A Roche Healthcare Consultant working with a lab director
Empowering clinical decisions with accurate and reliable results

A well-designed test rarely overlooks the thing you are looking for (sensitive) and rarely mistakes it for something else (specific).

This is especially important during local SARS-CoV-2 outbreaks around the world, when infection prevalence can fluctuate. Statistical models predict that an increase in testing specificity of just 1% (from 98.81 to 99.81) could have a significant impact on the prevalence of false positive results.5,6

As an example, for every 100,000 uninfected people tested for SARS-CoV-2:

  • A 98.81% test specificity would result in 1,190 (1.19%) false positive results
  • A 99.81% test specificity would result in 190 (0.19%) false positive results

False positive results may lead individuals to believe they have already been infected with the virus when they in fact have not.

integrated control concept

Integrated control concept

 

Standardized, clinically validated, and reliable laboratory results are essential in an outbreak scenario, both for healthcare professionals making treatment decisions and for governments monitoring the spreading of disease.

Each Roche analytical system employs an integrated control concept and extensive contamination controls to ensure every result contributes to the greater good.

Extensive contamination control

Extensive contamination control

Solutions for proven sustainability

With a proven history of innovation and trust, Roche empowers laboratories like yours to go confidently into the future.

Our extensive portfolio of innovative solutions is designed to help you meet the changing demands of your laboratory and deliver reliable results that inform the best patient care possible.

 

References

  1. Data on file with Roche
  2. Vermehren J, Stelzl E, Maasoumy B, et al. Multicenter Comparison Study of both Analytical and Clinical Performance across Four Roche Hepatitis C Virus RNA Assays Utilizing Different Platforms. J Clin Microbiol. 2017;55(4):1131-1139. doi:10.1128/JCM.02193-16
  3. Adams P, Vancutsem E, Nicolaizeau C, et al. Multicenter evaluation of the cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 system for the quantification of HIV-1 plasma viral load. J Clin Virol. 2019;114:43–49. doi:10.1016/j.jcv.2019.03.008
  4. Maasoumy B, Bremer B, Lehmann P, et al. Commutability and concordance of four hepatitis B virus DNA assays in an international multicenter study. Therap Adv Gastroenterol. 2017;10(8):609–618. doi:10.1177/1756283X17722745
  5. Lalkhen AG, McCluskey A. Clinical tests: sensitivity and specificity. Continuing Education in Anaesthesia Critical Care & Pain. Br J Anaesth. 2008;8(6):221-223
  6. Wellinghausen, N. Abele-Horn, M. Mantke, O.D. et al. MiQ. Immunological methods for the detection of Infectious Diseases. Instand. 2020. 978-3-87185-518-4