FDA Shares Performance Data from Covid-19 Antibody Test Kits
The results are among the first to come from a collaborative validation study of covid-19 antibody tests by BARDA, CDC, FDA, and NIH.
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Elecsys IL-6 Test Receives FDA EUA to Help Identify Patients at Risk of Severe Inflammatory Response
The test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirmed covid-19 who could be at high risk of intubation with mechanical ventilation.
Read MoreSiemens Healthineers Receives FDA EUA for SARS-CoV-2 Total Antibody Test
Siemens’ total antibody test for covid-19 has been shown to have 100% sensitivity and 99.8% specificity for identifying antibodies to SARS-CoV-2.
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FDA Issues Letter on Transport Media Safety Risk
Inappropriate use of certain transport media may incur a risk of exposure to harmful cyanide gas.
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Group Testing Combined with Digital PCR for Covid-19
For covid-19, group testing with digital PCR significantly reduces costs and increases testing capacity while offering high diagnostic sensitivity.
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