Roche announced in early September that it will launch a SARS-CoV-2 antigen rapid test for markets at the end of September. The test is approved in countries that accept the CE mark. Roche The company has also applied for Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
Info: This article is not sponsored but is intended to provide an overview of the new rapid antigen test from Roche . There are no conflicts of interest or dependencies with Roche and our company FM Mein Arztbedarf GmbH.
The SARS-CoV-2 antigen rapid test is intended for use at the point of care for both symptomatic and asymptomatic people. It can help healthcare professionals detect SARS-CoV-2 infection in people suspected of carrying the virus, with results usually available within 15 minutes.
In addition, it serves as a valuable initial screening test for individuals who have been exposed to SARS-CoV-2 infected patients or a high-risk environment. The test has a sensitivity of 96.52% and a specificity of 99.68% based on 426 samples from two independent study centers. At launch, 40 million SARS-CoV-2 rapid tests will be available each month. This capacity will more than double by the end of this year to meet the testing needs of healthcare systems worldwide.
The test is the tenth addition to the comprehensive diagnostics portfolio of Rocheto support healthcare systems in the fight against COVID-19 through laboratory and point-of-care testing. Currently, this portfolio includes molecular, serology and digital solutions to help diagnose and treat COVID-19 in the early stages of infection, during the recovery phase and after the infection has subsided.
The SARS-CoV-2 antigen rapid test is performed by healthcare professionals in a number of different settings close to the patient. This is very beneficial when timely decisions need to be made or laboratory tests are inaccessible. The test helps to quickly identify infected individuals and enables better patient management and more effective use of healthcare resources.
Thomas Schinecker, CEO of Roche Diagnostics, explained: "As the COVID-19 pandemic continues, healthcare systems remain challenged. Testing remains an important focus for many countries. Especially in the upcoming flu season, it is important to know if a person has SARS-CoV-2 or influenza to ensure proper treatment. To contain the spread of the COVID-19 virus in the community, COVID-19 testing solutions that give healthcare professionals and patients a quick answer to their infection status are crucial. We are working tirelessly to provide solutions with reliable SARS-CoV-2 testing solutions to help alleviate some of the burden in healthcare as we learn more about the disease and its impact on people around the world."
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The SARS-CoV-2 antigen rapid test from Roche is a rapid chromatographic immunoassay for the qualitative detection of a specific SARS-CoV-2 antigen in the human nasopharynx. This test is performed by healthcare professionals using a nasopharyngeal swab taken from a patient. The results are intended to facilitate early diagnosis of SARS-CoV-2 infection in patients with clinical symptoms of SARS-CoV-2 and to aid in the initial evaluation of patients. The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers. Results are available in just 15 minutes. This test is another important addition to the testing options for SARS-CoV-2 at the point-of-care, following the launch in July 2020 of the SARS-CoV-2 rapid antibody test was launched in July 2020 to help healthcare professionals identify patients who have developed antibodies to SARS-CoV-2, indicating a previous infection.
An antigen test detects proteins that are structural or functional components of a pathogen and are therefore very specific to that pathogen. In this case, the test would provide a qualitative "yes/no" answer to the presence of the pathogen in the patient sample and can be offered as a rapid test strip to be performed at the point of care. If the target antigen is present in sufficient concentration in the sample, it binds to specific antibodies and produces a visually detectable signal on the test strip, with results usually available in 15 minutes.
In general, antigen tests have a high specificity but are not as sensitive as molecular tests that amplify the viral target DNA or RNA sequence to produce a quantifiable signal indicating the presence of the virus in a sample. Therefore, to compensate for the potential decrease in sensitivity of an antigen test, negative results should be analyzed along with additional patient factors, such as COVID-19 exposure history, clinical symptoms, additional test results, to aid in the diagnosis and subsequent treatment of the patient.
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PCR tests can detect even the smallest virus DNA particles at an early stage and remain positive for a long time, even if the patient is no longer infectious.
Rapid tests detect viral proteins, for example, and are positive when a patient is most infectious. This type of rapid test is known as an antigen test. The new Roche SARS-CoV-2 antigen test is used for the qualitative detection of SARS-CoV-2 antigens. This test has been available since October and is packaged in 25 pieces.
Antibody tests recognize a patient's immune response and therefore only become positive after a few days. Immunoglobulin M antibody tests detect an active immune response, immunoglobulin G antibody tests detect an immune response that has already expired.
Click here for the blog article Rapid tests in comparison, what you need to know before buying
The COVID-19 pandemic continues to develop worldwide. This new test is another step in the fight against the COVID-19 pandemic.
A brief review of what has been done so far to combat the spread of COVID-19
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On March 13, we received Roche received emergency use authorization from the FDA for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries that accept the CE mark. On May 3, the Roche announced that their COVID-19 antibody test, which is designed to detect the presence of antibodies in the blood, has also received FDA emergency use authorization and is available in countries that accept the CE mark. Also in June, they received an EUA from the FDA for the Elecsys® IL-6 test to aid in the detection of severe inflammatory reactions in patients with confirmed COVID-19 and the launch of Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. In July Roche expanded its portfolio to include a rapid antibody test with SD Biosensor as a distribution partner, which enables the detection of antibodies against Covid-19 at the point of care. Roche is also currently working closely with governments and health authorities around the world and has significantly increased production to ensure the availability of tests worldwide.
Roche is a global pioneer in pharmaceuticals and diagnostics, focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have Roche to become the leading company in the field of personalized medicine - a strategy that aims to match the right treatment to each patient in the best possible way.
Roche is the world's largest biotech company with truly differentiated medicines in the fields of oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. In addition Roche is a global leader in in-vitro diagnostics and tissue-based cancer diagnostics as well as a leader in diabetes management.
Founded in 1896 Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve access for patients.
More than thirty of Roche are included in the World Health Organization's Model Lists of Essential Medicines, including life-saving antibiotics, antimalarials and cancer drugs. In addition Roche was recognized by the Dow Jones Sustainability Indices (DJSI) as one of the most sustainable companies in the pharmaceutical industry for the eleventh consecutive year.
The Roche-Group, headquartered in Basel, Switzerland, operates in over 100 countries and employed around 98,000 people worldwide in 2019. In 2019, the company invested Roche CHF 11.7 billion in research and development and generated sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche-Group. Roche is the majority shareholder of Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Info This article is not sponsored but is intended to provide an overview of the new rapid antigen test from Roche . There are no conflicts of interest or dependencies with Roche on our part.
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