A lot has been written about accuracy issues with the initially launched antibody tests, but a test at this level offers positive predictive values greater than 90% even in very low prevalence communities. "With 100% Positive Percent Agreement and 99.6% Negative Percent Agreement, our test significantly reduces the risk for false positives, delivering the results that health care providers and their patients can trust. "At a time when significant confusion was created by the initial influx of poor-quality antibody tests, our team worked meticulously to develop a highly sensitive and specific assay," said Julie Sawyer Montgomery, president of Beckman Coulter. " Henry Ford found when running the Beckman Coulter SARS-CoV-2 assay on 204 PCR-confirmed COVID-19 patient samples, a test sensitivity of 100% at 14 days post-PCR and testing of 80 patient samples from the pre-COVID era yielded a specificity of 100%."
Bernard C Cook, Division Head of Chemistry-Pathology, Henry Ford Health System. "We selected the Beckman Coulter Access SARS-CoV-2 IgG antibody assay to be the backbone of Henry Ford's COVID-19 serology testing program because of its outstanding performance in our rigorous independent evaluation," said Dr. Henry Ford Health System was one of the first health systems to receive Beckman Coulter's test and independently validate its performance. The company is able to deliver more than 30 million tests a month.
Beckman Coulter has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the U.S., and has begun distribution of the new antibody test globally to countries that accept the FDA EUA and CE Mark.
BREA, Calif., June 29, 2020 /PRNewswire/ - Beckman Coulter today announced that its Access SARS-CoV-2 IgG assay has received Emergency Use Authorization (EUA) from the U.S.
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