Immunoassays
News on immunoassay systems and applications.
Using laminated tape and ink, the researchers were able to control the capillary flow of fluids to make more complex tests.
InBios Gets FDA Emergency Use Authorization for OTC SARS-CoV-2 Antigen Test
The lateral flow immunoassay is designed for use at home with self-collected nasal specimens and provides results in about 20 minutes, according to the FDA.
FDA Reclassifies Certain Hepatitis C Diagnostic Tests, Blood Lancets
The final orders will ease the regulatory burden for some hepatitis C tests, but increase FDA oversight of blood lancets.
New Biomarker, Test From Wash U Team Aims to ID Patients at Higher Risk of Cardiovascular Disease
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The diagnostic blood test for elevated serum fatty acid synthase detected patients at risk of chronic limb-threatening ischemia with 83 percent accuracy.
The firm plans to submit at least three diagnostic assays to the FDA in the upcoming fiscal year, in addition to five life sciences products.