- Broad and trusted portfolio of COVID-19 rapid tests feature innovative updates and enhanced performance, building on insights gained throughout the pandemic
- All tests now work seamlessly with navify® Pass,
-
In doing so,
"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," said Thomas Schinecker, CEO,
The three tests set to launch are the following:
Professional use:
- SARS-CoV-2 Rapid Antigen Test 2.0 (nasopharyngeal sampling)
- SARS-CoV-2 Rapid Antigen Test 2.0 Nasal (nasal sampling)
Self-Test:
- SARS-CoV-2 Antigen Self Test Nasal (nasal sampling)
The tests join
About the next-generation portfolio of SARS-CoV-2 rapid antigen tests ("2.0")
Lab testing showed that all three tests can qualitatively detect major variants of concern including Delta and Omicron variants. Emerging variants are continuously monitored.
SARS-CoV-2 Rapid Antigen Test 2.01 (nasopharyngeal sampling)
The SARS-CoV-2 Rapid Antigen Test 2.0 is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasopharyngeal swab samples. In a prospective clinical studyA , the SARS-CoV-2 Rapid Antigen 2.0 showed a relative sensitivity of 99.00% (95% CI: 94.55 - 99.97%) and a relative specificity of 99.75% (95% CI: 98.62 - 99.99%). In total, 100 PCR-positive and 402 PCR-negative subjects participated in this study. This included 320 asymptomatic subjects, among whom 34 were positive and 286 were negative; and 182 symptomatic individuals, among whom 66 were positive and 116 were negative. This test is intended as an aid in the diagnosis of SARS-CoV-2 infection in individuals with or without symptoms consistent with COVID-19. This product is intended for professional use in laboratory and near-patient testing environments. This product is not intended for self-testing.
SARS-CoV-2 Rapid Antigen Test 2.0 Nasal2 (nasal sampling)
The SARS-CoV-2 Rapid Antigen Test 2.0 Nasal is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal swab samples. In prospective clinical studiesA,B, the SARS-CoV-2 Rapid Antigen 2.0 Nasal showed a relative sensitivity of 95.80% (95% CI: 91.09 - 98.44%) and a relative specificity of 100% (95% CI: 99.25 - 100%). In total, 143 PCR-positive and 487 PCR-negative subjects participated in these studies. This included 320 asymptomatic subjects, among whom 34 were positive and 286 were negative; and 310 symptomatic individuals, among whom 109 were positive and 201 were negative. This test is intended as an aid in the diagnosis of SARS-CoV-2 infection in individuals with or without symptoms consistent with COVID-19. This product is intended for professional use in laboratory and near-patient testing environments. This product is not intended for self-testing.
SARS-CoV-2 Antigen Self Test Nasal3
The enhanced SARS-CoV-2 Antigen Self Test Nasal is a so-called lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human nasal samples. This test is used to detect antigens of the SARS-CoV-2 virus in individuals suspected of having COVID-19. It is designed as a self-test for patients. In prospective clinical studiesA, B, the SARS-CoV-2 Antigen Self Test Nasal showed a relative sensitivity of 95.8% (95% CI: 91.09 - 98.44%) and a relative specificity of 100% (95% CI: 99.25 - 100%). In total, 143 PCR-positive and 487 PCR-negative subjects participated in these studies. This included 320 asymptomatic subjects, among whom 34 were positive and 286 were negative; and 310 symptomatic individuals, among whom 109 were positive and 201 were negative. 128 of the subjects were lay-users, sampling and testing themselves or another lay-user, for example their underaged childrenB.
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are very specific to that pathogen. In this case, the test would provide a qualitative "yes/no" answer on the presence of the antigen in the patient sample and can be offered as a rapid strip test that is performed by healthcare professionals at the point of care or by individuals at home. 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 test strip, typically with results ready in 15 minutes.2 A rapid antigen test can reliably detect individuals with a high viral load allowing healthcare professionals to quickly identify those patients at the greatest risk of spreading the infection.
In general, antigen tests have a high specificity, though are not as sensitive as molecular tests that amplify the target DNA or RNA sequence in order to generate a (semi-)quantifiable signal to indicate the presence of the pathogen in a sample. Therefore, to make up for the potential decrease in sensitivity of an antigen test, negative results should be analysed together with additional information, such as the individual's exposure history, clinical symptoms, and additional test results to help guide the diagnosis and subsequent treatment of the patient.
About
As a leading healthcare company, we are doing all we can to support countries in their fight against COVID-19 and minimising its impact. That is why we are working with governments, policy makers, healthcare professionals and others to help contain the COVID-19 pandemic and make sure patients continue to receive the tests, treatment and care they need.
The pandemic has profoundly raised awareness of the role diagnostics play in COVID-19 diagnosis, treatment development and disease management.
We have also been partnering with Regeneron to jointly develop the antibody combination Ronapreve(TM) (casirivimab and imdevimab, known as
Our utmost goal remains to be a trusted partner
About
For more information, please visit http://www.sdbiosensor.com.
About
Founded in1896 in
In recognizing our endeavor to pursue a long-term perspective in all we do,
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1]
[2]
[3]
A) A prospective study in
B) A prospective, lay-use study in
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