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The test targets antibodies for the viral spike protein and can characterize a vaccine-induced immune response.
The BioCheck chemiluminescence tests can process human serum samples in 30 minutes to detect IgG and IgM antibodies.
DeCode Genetics researchers found patients' antibody titers increased in the two months following diagnosis, then stabilized.
Researchers analyzed the performance of a dozen SARS-CoV-2 serology assays on samples from COVID-19 patients, patients with other disease, and pre-pandemic samples.
About 3.4 million people, or 6 percent of the population in England, was likely infected by SARS-CoV-2 by July 13. People of color had higher rates of infection.
The lateral flow antibody test kit has a combined IgG/IgM sensitivity of 100 percent and specificity of almost 99 percent and received EUA in June.
According to the agreement, Access Bio must sell at least 2 million tests by Sept. 30, 2021, to keep its exclusive rights in North America.
Unilabs Denmark, the local subsidiary of the European diagnostic services provider, will carry out antibody testing as part of the effort.
According to the registry's first dataset, more than 65 million tests have been manufactured and shipped across the US.
The company plans to use the proceeds of the round to fund ongoing development and commercialization of its point-of-care diagnostic platform.