Roche ($RHHBY) launched its Elecsys Anti-SARS-CoV-2 S antibody test for markets that accept the CE mark. It has also filed with the Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA).
The test can be used to measure antibodies in people exposed to COVID-19. The company believes the test can play an important role in characterizing a vaccine-induced immune response, meaning it can be used in clinical trials to evaluate the effectiveness of experimental COVID-19 vaccines in stimulating an immune response against the SARS-CoV-2 virus that causes COVID-19.
The assay targets antibodies directed against the specific portion of the viral spike (S) protein that the virus uses to bind to the host cell receptor and is required to enter the host cell. Most vaccine candidates, as well as therapeutic antibodies, target the spike protein.
The test is a serology test. It can also be used to identify antibody levels in plasmapheresis donations. Roche notes that performing a combination of the Elecsys Anti-SARS-CoV-s S and Elecsys Anti-SARS-CoV-2 tests can help doctors and public health authorities more effectively determine which proportion of a given population has antibodies against the virus, especially in environments with low to moderate seroprevalence. This can be used to contain the spread of the virus and provide information on how to securely relax lockdown restrictions.
One type of therapy, reparative antibody therapy, which is granted in the US EUA for the treatment of COVID-19 patients, draws blood from patients who have recovered from the disease and uses plasmapheresis to remove the plasma from the blood. The plasma is then given to COVID-19 patients, with the theory that they will have antibodies to the virus to fight it in these sick patients. This new test allows for a higher test level of the antibodies, with a clinical specificity of 99.98 procent and a sensitivity of 98.8 procent, 14 days or later after the diagnosis of COVID-19 with a PCR test.
The test has also been shown not to be cross-reactive with other endemic human coronaviruses, respiratory infectious diseases, other infectious diseases, autoimmune diseases and liver-related diseases.
The assay can be performed on Roche’s cobas e-analyzers, which are deployed around the world. The fully automated systems are capable of performing SARS-COV-2 test results in about 18 minutes, with a test throughput of up to 300 tests per hour, depending on the analyzer.
“As the possibility of an effective SARS-CoV-2 vaccine becomes a reality, quantitative measurement of antibodies will be crucial in the evaluation of any potential vaccine. The new quantitative Elecsys antibody assay could play a critical role in vaccine clinical trials and To help clinicians assess the immune response of patients, this will play an important role in protecting those most vulnerable to the virus and in overcoming COVID-19 for society at large.This new test, the twelfth in the Roche SARS-CoV-2 testing portfolio, is another essential addition to support healthcare systems and patients as we jointly combat COVID-19, ” Thomas Schinecker said, CEO of Roche Diagnostics.
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