Characteristics
- Rapid antigen combination test rapidly differentiates between SARS-CoV-2 infections and influenza A and B viruses, with results ready in less than 30 minutes, enabling informed patient management decisions and pandemics.
- A small, affordable test kit with no instruments enables convenient use for healthcare professionals across multiple point-of-care and resource-limited settings
- The test works seamlessly with NAVIFY® Pass, Roche’s digital solution that enables individuals and healthcare professionals to immediately store, display and share COVID-19 test results and vaccine status via a single data array.
Introduction
Basel, December 6, 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced plans to launch the rapid SARS-CoV-2 and influenza A/B antigen test for professional use in markets that accept the brand. CE for the beginning of January. Roche also intends to apply for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) in early 2022.
The SARS-CoV-2 and Influenza A/B Rapid Antigen Test is intended for use by healthcare professionals to rapidly differentiate between SARS-CoV-2 and influenza A and B virus infections in people with symptoms consistent with COVID-19 or influenza. The unique integrated combination test uses a nasopharyngeal swab sample to produce qualitative results (“yes/no” response) on the presence of SARS-CoV-2 and/or influenza A and/or B antigens in 15-30 minutes.
The test has a relative sensitivity of 84.85% and a specificity of 98.59% for SARS-CoV-2. For influenza, the test has a positive per cent agreement of 81.16% (influenza A virus) and 100% (influenza B virus) against a molecular test, and relative specificity of 100% (influenza virus). influenza A) and 99.04% (influenza B virus). Currently available sequences of the Omicron SARS-CoV-2 variant (B.1.1.529) have been analyzed and based on initial in silico investigations, an impact on test performance is not expected.
Equipping healthcare professionals with a single integrated combination test is beneficial in settings where timely clinical decisions are needed or where central laboratory testing is difficult to access. The SARS-CoV-2 and Influenza A/B Rapid Antigen Test helps point-of-care healthcare professionals rapidly diagnose and differentiate infections with any of the three respiratory viruses and helps guide appropriate courses of action, including patient and pandemic management decisions.
Thomas Schinecker, CEO of Roche Diagnostics, said: “It is critical that healthcare professionals have the ability to quickly tell if a patient has a SARS-CoV-2 infection or the flu, especially as the COVID-19 pandemic continues. 19 extends into our flu season. The combined rapid antigen test will help ensure healthcare providers are making the right decisions to treat patients and ultimately prevent community spread. The test adds a solution that will be critical to the long-term management of SARS-CoV-2 and seasonal influenza in healthcare systems as we transition from today’s global health emergency to tomorrow’s endemic phase.”
Along with the rapid SARS-CoV-2 and influenza A/B antigen test, Roche offers the NAVIFY® Pass. This digital solution enables individuals and healthcare professionals to remotely store, display and share their COVID-19 test results and vaccination status. With a unique and personalized data matrix placed on the test, NAVIFY® Pass can automatically read all the details about the test and make a connection between patients and their individual test results.
The launch will be in partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and previously launched SARS-CoV-2 Antigen Rapid Tests (Nasopharyngeal/Nasal), SARS-CoV-2 Antigen Self Test Nasal and SARS -CoV-2 Antibody Rapid Test in countries accepting the CE mark during 2020 and 2021. The test will become the fifth rapid test and the 22nd addition to Roche’s comprehensive portfolio of diagnostic solutions to help systems health care providers around the world to combat the COVID-19. pandemic through laboratory and point-of-care testing. The Roche Diagnostics portfolio includes a wide range of molecular, serological and digital solutions that help diagnose and manage COVID-19 during the early stages of infection.
About the SARS-CoV-2 and Influenza A/B Rapid Antigen Test
The SARS-CoV-2 and Influenza A/B Antigen Rapid Test is a rapid chromatographic immunoassay for the simultaneous detection and differentiation of the nucleocapsid protein antigens of SARS-CoV-2, influenza A virus and influenza A virus. Influenza B viruses in human nasopharyngeal swab specimens. . This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A virus, and influenza B virus infections in persons suspected of having respiratory viral infections compatible with COVID-19 or influenza by health care providers within the first five days of the onset of symptoms.
The test has a relative specificity of 98.59% for SARS-CoV-2, 100% for influenza A viruses, and 99.04% for influenza B viruses. The relative sensitivity for SARS- CoV-2 was 84.85%. These performance characteristics are based on a prospective study of 104 participants in which two nasopharyngeal swab specimens per participant were collected and the rapid antigen test results were compared with those of an FDA-approved RT-PCR method of high sensitivity.
Susceptibility for influenza A and B viruses was tested separately using stored human nasopharyngeal swab samples due to the limited circulation of influenza viruses in the past season. The results of the rapid antigen test were compared with the results of the high-sensitivity RT-PCR method, and the positive percentage of agreement for influenza A and B viruses was 81.16% and 100%, respectively. A prospective clinical study is underway to evaluate the performance of influenza using fresh clinical samples. This test is not for self-assessment. It is designed for professional use in laboratory and near-patient testing environments.
About antigen tests
An antigen test detects proteins that are structural or functional components of a pathogen and are highly specific for that pathogen. In this case, the test would provide a qualitative “yes/no” answer on the presence of the antigen in the patient’s sample and can be offered as a rapid strip test that is performed by healthcare professionals at the point of care. If the target antigen (in this case, the nucleocapsid protein) is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the dipstick, typically with results ready in 15-30 minutes. A rapid antigen test can reliably detect people with a high viral load, allowing healthcare professionals to quickly identify patients at higher risk of spreading infection.