Roche launches its next-generation SARS-CoV-2 Rapid Antibody Test


In markets that recognise the CE Mark, Roche today announced the availability of the SARS-CoV-2 Rapid Antibody Test 2.0. The examination replaces Roche’s SARS-CoV-2 Rapid Antibody Test, which was introduced in July 2020. The SARS-CoV-2 Rapid Antibody Test 2.0 extends its original scope of application, which concentrated on recovered patients, to now now include those who have received vaccinations. The test has also been improved to better detect antibodies against viral variants, and it is still being researched against emerging variants of concern.

Healthcare practitioners can use the SARS-CoV-2 Rapid Antibody Test 2.0 in point-of-care settings outside of clinical labs and close to patients with a capillary sample. The test could make it easier for medical practitioners to spot people who have SARS-CoV-2 antibodies, a sign of a prior illness or immunisation. When quick judgments are required, laboratory SARS-CoV-2 testing is not possible, or finger prick collection is preferable to venous blood sample, the SARS-CoV-2 Rapid Antibody Test 2.0 is helpful. The test can also be used by medical practitioners to assist patients in assessing their antibody status and figuring out whether they still have a detectable antibody response from an earlier immunisation.

“The next-generation of our SARS-CoV-2 Rapid Antibody Test demonstrates Roche’s continued commitment to innovate as the COVID-19 pandemic evolves”, “We are proud to introduce an improved antibody test that, given its point of care use, offers healthcare professionals greater speed and accessibility in providing the right care to those that need it.”

Ian Parfrement, Head of Point of Care at Roche Diagnostics

The test was introduced in collaboration with SD Biosensor Inc., with whom Roche has a global distribution agreement and who has already introduced a number of quick antigen and antibody assays in more than 50 nations worldwide. The SARS-CoV-2 Rapid Antibody Test 2.0 is the newest addition to Roche’s extensive diagnostic range of COVID-19-fighting tools, which also includes molecular, serology, and digital solutions.

SARS-CoV-2 Rapid Antibody Test 2.0 Information

A quick chromatographic immunoassay called Roche’s SARS-CoV-2 Rapid Antibody Test 2.0 is designed for the qualitative identification of IgG antibodies to SARS-CoV-2 in human serum, plasma, or whole blood. In a point-of-care setting, this test can be run using blood from a finger prick and yield high performance results in 10 to 15 minutes. The findings may point to a virus-specific adaptive immune response.

The test has a sensitivity of 98.67% and 100.00% after the second and booster injection, respectively, when run 3–4 weeks following vaccination, when it is anticipated that IgG antibody levels will plateau. The test has a sensitivity of 95.83% and a specificity of 100.00% when administered to a non-vaccinated population at least 15 days after the onset of symptoms.

A clinical investigation involving patients immunised with vaccines from Moderna, Pfizer/BioNTech, AstraZeneca, and Johnson & Johnson proved the test’s capacity to identify antibodies after vaccination against SARS-CoV-2.

Concerning antibody testing
In reaction to numerous infectious diseases, the human body produces antibodies. In the current COVID-19 pandemic, tests to detect antibody responses to SARS-CoV-2 are essential to support vaccine development, add to our knowledge of the rate and spread of infection among populations, and, if scientific evidence shows, to ascertain whether a person may have developed immunity against the virus. There is still no widespread consensus in the literature regarding a specific antibody level that would provide immunity to SARS-CoV-2 infection.

Without cross-reactivity to other infectious agents, such influenza, which could result in a false positive result, antibody testing must be able to precisely detect antibodies against SARS-CoV-2. When a person (incorrectly) receives a positive test result when they should have received a negative result because they don’t have SARS-CoV-2 specific antibodies in their blood, that is known as a false positive result.

Regarding SD Biosensor
An international in-vitro diagnostic company called SD Biosensor is dedicated to the creation of point-of-care immunoassay and molecular diagnostic solutions. Since its founding in 2010, SD Biosensor has kept up its research and product development in order to help doctors diagnose patients quickly and accurately throughout the testing process. They are working to establish themselves as a major international in vitro diagnostics company using these cutting-edge products.

Concerning Roche’s reaction to the COVID-19 epidemic
As a top healthcare provider, we are doing everything in our power to aid nations in their efforts to combat COVID-19 and lessen its effects. To assist contain the COVID-19 epidemic and ensure that patients continue to receive the testing, treatments, and care they require, we are collaborating with governments, policymakers, healthcare providers, and others.

The pandemic has significantly increased awareness of the importance of diagnostics in the diagnosis of COVID-19, the development of treatments, and the management of disease. More than 20 COVID-19 diagnostics have been created and released by Roche, including PCR and quick tests for antigens and antibodies. Our systems cover all currently recognised varieties and service the whole diagnostic continuum, from high-throughput laboratories to point-of-care and home self-testing. Since March 2020, we have provided more than 1.5 billion COVID-19 tests to help meet the demand on a global scale.

Roche is still assessing the efficacy of its current therapeutics and looking at potential new treatments for COVID-19 patients. In more than 30 countries, including the European Union, our IL-6 inhibitor Actemra®/RoActemra® (tocilizumab) has been approved for patients hospitalised with severe COVID-19. It is also approved for emergency use in the United States. As a result of Actemra’s prequalification by the World Health Organization for use in patients with severe COVID-19, its accessibility in low- and middle-income nations is made easier. Additionally, by implementing a global differentiated pricing strategy, offering Actemra at cost for usage in low- and middle-income nations, and refraining from asserting patents in these areas during the epidemic, we have improved access to the medication.

In addition, we have been working together with Regeneron to create the antibody combination RonapreveTM (casirivimab and imdevimab, also known as REGEN-COVTM in the US). It has received authorization for emergency or temporary pandemic usage in numerous nations, including the US, the European Union, Japan, and Switzerland. In excess of 60 nations, including low- and middle-income nations, have made the antibody combination available to patients. We are continuously tracking Ronapreve’s activity against new, concerning virus variations as it continues to evolve, and we will communicate findings with health authorities as soon as we can.

  • Healthcare providers can now utilise the SARS-CoV-2 Rapid Antibody Test 2.0 on more people, including those who have been immunised and those who have recovered from infection.
  • Additionally, to enhance the detection of antibodies against virus variants, the SARS-CoV-2 Rapid Antibody Test 2.0 has been upgraded. Its efficacy against emerging virus variants of concern is still being researched.
  • The COVID-19 test is fully compatible with Roche’s navify® Pass, a digital solution that enables patients and healthcare providers to instantly store, display, and share their test results as well as their vaccination status.
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