The Swiss healthcare company said that lab testing has demonstrated that all three tests can qualitatively detect Delta and Omicron along with other major variants of concern variants
Roche to launch its next-generation range of SARS-CoV-2 rapid antigen tests (2.0). (Credit: F. Hoffmann-La Roche Ltd)
Roche has announced the roll of three next-generation range SARS-CoV-2 rapid antigen tests (2.0) for professional use and self-testing in countries accepting the CE Mark.
According to the Switzerland-based company, SARS-CoV-2 Rapid Antigen Test 2.0 and SARS-CoV-2 Rapid Antigen Test 2.0 Nasal are meant for professional use, while SARS-CoV-2 Antigen Self Test Nasal is for self-testing.
The company expects the distribution of the new rapid test products to start in the coming weeks.
Roche said that all the new tests are compatible with its navify Pass digital solution that lets healthcare professionals and individuals to immediately store, display, and share the status of Covid-19 vaccination and test results using a data matrix.
The new tests, which use nasal and nasopharyngeal swab samples, provide results in 15 minutes to assist in the identification of SARS-CoV-2 infection in people with or without symptoms similar to Covid-19.
Roche Diagnostics CEO Thomas Schinecker said: “The continued evolution of the SARS-CoV-2 virus and Covid-19 pandemic reinforce the need for individuals and healthcare systems to have access to the most reliable rapid testing solutions possible.
“As a leader in diagnostic innovation, we are proud to be one of the first among our industry to apply insights gained from the past two years toward a next-generation rapid test portfolio.”
The Swiss healthcare company said that lab testing has shown that all the three tests are capable of qualitatively detecting Delta and Omicron along with other major variants of concern variants.
The SARS-CoV-2 Rapid Antigen Test 2.0 is said to be a rapid chromatographic immunoassay for qualitatively identifying the nucleocapsid protein of SARS-CoV-2 contained in human nasopharyngeal swab samples.
In a clinical study on 100 PCR-positive and 402 PCR-negative subjects, the test showed a relative sensitivity of 99% and a relative specificity of 99.75%, the healthcare firm said.
The SARS-CoV-2 Rapid Antigen Test 2.0 Nasal is claimed to be a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 contained in human nasal swab samples.
In a clinical study on 143 PCR-positive and 487 PCR-negative subjects, the test gave a relative sensitivity of 95.8% and a relative specificity of 100%, Roche added.
Designed as a self-test for patients, the SARS-CoV-2 Antigen Self Test Nasal is a so-called lateral flow test used to identify SARS-CoV-2 nucleocapsid antigen present in human nasal samples.
In a clinical study on 143 PCR-positive and 487 PCR-negative subjects, it showed a relative sensitivity of 95.8% and a relative specificity of 100%.
The company will launch the tests in partnership with SD Biosensor with whom it has a global distribution agreement.