Article

SARS-CoV-2

The unexpected threat that put the world on hold

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) gained worldwide infamy in late 2019 as the trigger of the respiratory tract disease, COVID-19.

What started as reports of pneumonia cases in December 2019, quickly grabbed the world’s attention. In January 2020, the World Health Organization (WHO) declared the novel coronavirus a global emergency. Within the first 6 months, the pandemic caused nearly 500,000 deaths, strained worldwide health systems, and led to immeasurable disruption of global economies.1-3

A silently spreading infection

COVID-19 may present symptoms consistent with other respiratory infections or may not show any noticeable symptoms at all, elevating the need for widespread diagnostic testing. Administering the right test, at the right time, can inform appropriate counter measures, like self-isolation in mild cases or hospitalization in moderate to severe cases.4

SARS-CoV-2 and antibodies
Shining a light on SARS-CoV-2 testing

Not all diagnostic tests are created equal, and on a global scale the impact is exacerbated. In the early months of the COVID-19 pandemic, a large number of assays were fast-tracked for use through programs like the FDA's Emergency Use Authorization. Some of these tests came under later scrutiny due to concerns around performance, which heightened the need for accurate tests to be available.5

Several types of tests are used for SARS-CoV-2 monitoring, including polymerase chain reaction (PCR) tests, antigen tests, and antibody tests, among others. These tests serve different purposes and it is important to understand which test is appropriate for which situation.

sars-cov-2 illustration

PCR tests have high analytical sensitivity, allowing them to reliably detect the current presence or absence of a pathogen.

  • Why accuracy is important: False negative results may pose a serious medical risk for patients and, in the case of SARS-CoV-2, could lead to further spread of the virus to others

 

Antibody tests do not directly detect the presence of a pathogen. Instead, they detect the presence of antibodies, which are produced by the body during an immune response. Here, specificity is important.

  • Why accuracy is important: False positive results may lead people to believe they have been exposed to the virus and have developed antibodies, when in fact they have not

Timely results generated from accurate tests not only empower healthcare professionals to better inform patient management, they enable health officials to more effectively track and monitor the spread of disease. Robust testing options, including multiplex assays and systems that can scale as demand grows, are important tools in pandemic management.

view inside the cobas 6800
Addressing demand for SARS-CoV-2 testing

Over the past three decades, Roche consistently developed highly sensitive and specific molecular and serologic tests which are considered the gold standard for detecting the presence of viral agents. With a growing menu of SARS-CoV-2 assays, Roche ensures that testing sites—from large reference laboratories to emergency rooms, urgent care clinics, and walk-through test stations—can provide reliable results when and where they are needed most.

When global demand for testing initially spiked, Roche developed the first commercial EUA test for use in the US to detect SARS-CoV-2 followed quickly by a leading serology test with 99.8% specificity.6 The portfolio continued to grow with additional testing solutions:

IT supporting looking at a laptop
Driving scalability and support for future outbreak protection

Behind every patient sample is a life. This is the driving force behind Roche’s relentless commitment to innovation.

As the virus spread, demand for tests and reagents grew. Roche’s global supply chain, local support capabilities, and ability to accelerate set-up times ensured laboratories around the world had the products and information needed to support local communities. Today, the world is better equipped to counter the impact of SARS-CoV-2 with a wide range of testing systems that support patient needs:

  • High-throughput fully automated IVD systems

  • Single sample POC PCR system

  • Flexible laboratory developed testing (LDT) solutions

  • Fully automated immunoassay analyzer

  • Next-generation sequencing kits and workflows for further research about the virus 

Delivering digital solutions that transform testing and treatment

Roche digital healthcare diagnostic solutions

To help laboratories get the most out of their equipment, Roche’s digital diagnostic solutions work to improve laboratory operations and output with actionable insights into resources, workflows and performance.

Learn more about digital diagnostics
Roche mobile app diagnostic solutions

To empower patients to engage in care, Roche developed a disease management solution to support elimination programs—composed of a ​mobile app for patients and aggregated dashboards for program managers​.

Timely availability and fast access to reliable, high-quality tests are essential for healthcare systems.

 

Thomas Schinecker
Chief Executive Officer of Roche Diagnostics

Doing now what patients need next

Roche is deeply committed to supporting the worldwide response to end the COVID-19 pandemic.

As the landscape for SARS-CoV-2 testing matures, Roche’s proven innovations and robust infrastructure will continue to support global and local efforts to control the spread of disease.

illustration of the covid-19 virus

Roche’s response to the COVID-19 pandemic

Roche is deeply committed to supporting the global response to put an end to the COVID-19 pandemic.

 

  1. World Health Organization. WHO Director-General's opening remarks at the media briefing on COVID-19 - 29 June 2020. https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---29-june-2020. Accessed July 27, 2020.
  2. United Nations. Socio-economic impacts of COVID-19. https://www.un.org/en/un-coronavirus-communications-team/launch-report-socio-economic-impacts-covid-19. Accessed July 27, 2020.
  3. United Nations. World Economic Situation And Prospects: April 2020 Briefing, No. 136. https://www.un.org/development/desa/dpad/publication/world-economic-situation-and-prospects-april-2020-briefing-no-136/. Accessed July 27, 2020.
  4. World Health Organization. Coronavirus disease 2019 (COVID-19) Situation Report – 46. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200306-sitrep-46-covid-19.pdf?sfvrsn=96b04adf_4. Accessed July 27, 2020.
  5. Food and Drug Administration. FDA Informs Public About Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-informs-public-about-possible-accuracy-concerns-abbott-id-now-point. Accessed August 25, 2020.
  6. Elecsys® Anti-SARS-CoV-2. Package Insert 2020-07, V3.0; Material Numbers 09203095190 and 09203079190.