Roche announced its plans to launch the SARS-CoV-2 and Flu A/B Rapid Antigen Test for professional use in markets accepting the CE Mark by the beginning of January.
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Roche also intends to file for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) in early 2022.
The SARS-CoV-2 and Flu A/B Rapid Antigen Test is intended for use by healthcare professionals to rapidly differentiate between SARS-CoV-2 and influenza viruses A and B infections in individuals with symptoms consistent with COVID-19 or influenza.
The single integrated combination test uses a nasopharyngeal swab specimen to produce qualitative results (“yes/no†answer) on the presence of SARS-CoV-2 and/or influenza A and/or B antigens in 15 to 30 minutes.
The test has a relative sensitivity of 84.85% and specificity of 98.59% for SARS-CoV-2. For the flu, the test has a positive percent agreement of 81.16% (influenza virus A) and 100% (influenza virus B) against a molecular test, and relative specificity of 100% (influenza virus A) and 99.04% (influenza virus B).
The currently available sequences of the Omicron variant SARS-CoV-2 (B.1.1.529) have been analyzed, and based on the initial in silico investigations, an impact on the performance of the test is not expected.
Together with the SARS-CoV-2 and Flu A/B Rapid Antigen Test, Roche is offering NAVIFY Pass. This digital solution allows individuals and healthcare professionals to remotely store, display, and share their COVID-19 test results and vaccine status.
With a unique and personalised data matrix placed on the test, NAVIFY Pass can automatically read out all details about the test and establish 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 the SARS-CoV-2 Rapid Antigen Tests (Nasopharyngeal/Nasal), SARS-CoV-2 Antigen Self Test Nasal, and SARS-CoV-2 Rapid Antibody Test in countries accepting the CE Mark throughout 2020 and 2021.
The test will become the fifth rapid test and twenty-second addition to Roche’s comprehensive portfolio of diagnostic solutions to help healthcare systems across the globe combat the COVID-19 pandemic through laboratory testing and at the point of care.
The SARS-CoV-2 and Flu A/B Rapid Antigen Test is a rapid chromatographic immunoassay for the simultaneous detection and differentiation of the nucleocapsid protein antigens of SARS-CoV-2, influenza virus A, and influenza virus B in human nasopharyngeal swab samples.
The test has a relative specificity of 98.59% for SARS-CoV-2, 100% for influenza viruses A and 99.04% for influenza viruses B. The relative sensitivity for SARS-CoV-2 was 84.85%.
These performance characteristics are based on a prospective study of 104 participants where two nasopharyngeal swab samples were collected per participant and results of the rapid antigen test were compared with those from a highly-sensitive, FDA-cleared RT-PCR method.
The sensitivity for influenza viruses A and B was evaluated separately using banked human nasopharyngeal swab samples, due to the limited circulation of influenza viruses in the past season.
The rapid antigen test results were compared to highly sensitive RT-PCR method results, and the positive percent agreement for influenza viruses A and B were 81.16% and 100%, respectively.
A prospective clinical study is ongoing to evaluate the influenza performance using fresh clinical samples. This test is not for self testing. It is intended for professional use in laboratory and near patient testing environments. ■