TAG:
serological testing
Questions Arise as FDA Assesses Serology Tests
CEO SUMMARY: On June 4, the FDA released results of an evaluation of some of the 20 tests offered for sale in this country to identify antibodies for SARS-CoV-2. A quality control expert in clinical labs called the antibody test analysis deeply flawed in part because of the study’s …
California Research Team Analyzes Performance of 12 Serological Tests
This is an excerpt of a 2.241-word article in the May 11, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Researchers with the COVID-19 Testing Project used a multidisciplinary effort to analyze and compa…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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