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The Access SARS-CoV-2 IgG II test is a semi-quantitative test that measures a patient’s relative antibody level in response to a previous SARS-CoV-2 infection
Beckman Coulter, a leader in clinical diagnostics, has launched its Access SARS-CoV-2 IgG II test which measures a patient’s relative antibody level in response to a previous SARS-CoV-2 infection. The new capabilities of this test allow doctors to establish a baseline to assess an individual’s immune response to the SARS-CoV-2 virus based on a numerical value and assess relative changes in an individual’s immune response to the virus in the time. The test can also help researchers as they begin to understand the levels of IgG antibodies needed to be considered protective.
The organization is applying for emergency use authorization of the assay from the U.S. Food and Drug Administration (FDA) and will immediately begin shipping assays to its customer base in the United States under the D. Beckman Coulter policy is also planning to make the assay available to markets to accept the CE mark later this year.
“Having a clearer picture of the immune response to SARS-CoV-2 plays an important role in the fight against COVID-19, especially before a vaccine is widely available,” said Shamiram R. Feinglass, MD, MPH, chief medical officer. Beckman Coulter. “Although it is not known how long antibodies persist after infection and whether the presence of antibodies confers protective immunity, having a quantifiable baseline is a critical step towards further understanding the adaptive immune response to SARS. CoV-2 in individuals over time “.
The Semiquantitative Access SARS-CoV-2 IgG II assay provides a numerical result in arbitrary units (AU) from 2.00 to 450 AU / mL, as well as a qualitative result and offers the same high level of quality as Beckman’s Access SARS-CoV Coulter -2 IgG and IgM serological tests already on the market. The assays use the receptor binding domain (RBD) of the spike protein. Beckman Coulter selected the spike protein RBD as it is critical for viral entry into human cells and proved to be the target for neutralizing antibodies in a surrogate model. This selection is also aligned with multiple vaccines in development that target or include spike protein RBD, with the goal of producing protective antibodies.
The Semiquantitative Access SARS-CoV-2 IgG II Test is the latest addition to the comprehensive suite of Beckman Coulter testing solutions designed to provide valuable insights to clinicians in their fight against COVID-19. The organization’s next anticipated product is an automated SARS-CoV-2 antigen test that is currently in development. Although point-of-care (POC) antigen tests serve a purpose in diagnosing COVID-19, they are difficult and require a lot of resources to scale to meet high-volume testing needs. Beckman Coulter’s Antigen Testing has been designed to provide maximum flexibility in scaling to meet the needs of small and moderately complex laboratories using a desktop analyzer, to large laboratories deploying high-throughput automated analyzers for bulk testing.
About the Access SARS-CoV-2 IgG II assay
The Access SARS-CoV-2 IgG II assay is a semi-quantitative and qualitative immunoassay that measures IgG antibodies directed to the binding domain of the spike protein receptor of the novel coronavirus in response to a previous infection. The test then provides a numerical result between 200-450 / mL as well as a qualitative result for SARS-CoV-2 IgG antibodies.
The test has a confirmed positive agreement rate of 96.0% (PPA, sensitivity) 8-14 days after symptom onset and a negative agreement rate of 99.9% (NPA, specificity) evaluated in a study with 1,448 donor samples in the United States and France collected previously. as of December 2019. With this high NPA rate, false positive results are extremely low to ensure accurate and reliable test results. It uses viral antigens immobilized on magnetic particles to capture IgG antibodies from patient serum or plasma samples and detects them using labeled anti-IgG antibodies.
The Access SARS-CoV-2 IgG II assay can be used in Random Access (RAM) mode and seamlessly integrated into existing workflows without batch processing. Results from the new Access SARS-CoV-2 IgG II assay are delivered quickly on Beckman Coulter’s award-winning immunoassay analyzers, including the DxI 800 high-throughput analyzer, which can process 200 samples per hour. For more information on Beckman Coulter’s full suite of testing solutions or its commitment to fighting COVID-19, visit www.BeckmanCoulter.com/Coronavirus.
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