Article Reports Results from Independent Study Demonstrating Test's 100% Sensitivity and Specificity for IgM Antibodies and 96.7% and 97.5% Sensitivity and Specificity, Respectively, for IgG ...
The current COVID-19 pandemic is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a betacoronavirus that causes severe acute respiratory distress in a significant proportion of ...
The analysis included results from 2 tests that have received EUA: the SARS-CoV-2 ELISA test (Euroimmun) and the COVID-19 IgG/IgM Rapid Test Cassette (Healgen). The Food and Drug Administration (FDA) ...
Announcing a new article publication for Zoonoses journal. The COVID-19 pandemic, which was caused by SARS-CoV-2, has had a significant effect on global public health, economies, and societies ...
Assay has 99.9% specificity and 98.3% sensitivity at 15-30 days post-symptom onset and confirmed 95.5% positive predictive value when disease incidence is as low as 3% Beckman Coulter developed ...
Company in Late-Stage Negotiations to Secure Distribution Agreement for Additional COVID-19 IgG/IgM Rapid Test Which is Approved by China's National Medical Products Administration (NMPA) ENGLEWOOD, ...
SAN FRANCISCO, Calif. (KRON) — The U.S. Food and Drug Administration on Monday gave Emergency Use Authorization for Abbott’s IgM coronavirus antibody test. The IgM, or Immunoglobulin M, antibody test ...
InBios has announced that it received an Emergency Use Authorization (EUA) from the FDA for its ZIKV Detect™ IgM Capture ELISA. The product is intended for the presumptive detection of Zika virus IgM ...
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