SARS-CoV-2

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.

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.

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:

• High-throughput multiplex SARS-CoV-2 and Influenza A/B test
• Rapid multiplex POC SARS-CoV-2 and Influenza A/B PCR test
• Rapid POC SARS-CoV-2 Antibody test
• Rapid POC SARS-CoV-2 Antigen test
• Interleukin 6 (IL-6) biomarker test
• Blood gas testing
• Digital symptom tracker

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

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.