TAG:
serology test
COVID-19 Serology Test Claims 98.8% Accuracy
CEO SUMMARY: When it announced its new antibody test for the novel coronavirus SARS-CoV-2 on May 3, Roche Holdings explained that its sensitivity level after 14 days was 100%, which is an important point to understand about the test. When assessing Roche’s claims, two expert…
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…
FDA Replaces March 16 Serology COVID-19 Rules
CEO SUMMARY: In the rush to allow companies and clinical laboratories to develop, validate, and bring to market serological tests for COVID-19, the federal Food and Drug Administration issued rules on March 16 that eased its requirements for these new assays. Because of the la…
California Research Team Analyzes Performance of 12 Serology Tests
CEO SUMMARY: Researchers with the COVID-19 Testing Project used a multidisciplinary effort to analyze and compare the performance of 12 serological tests. One finding is that, 16 to 20 days or more after a confirmed infection with a molecular test, many of the 12 serological te…
Lab, Path Finances Crash; Next Test Wave: Serology
CEO SUMMARY: For clinical laboratories and anatomic pathology groups, the day-by-day impact of the COVID-19 pandemic is unfolding much like Hurricane Katrina hitting New Orleans in 2005. Every 24 hours, labs get unwelcome news, along with uncertainty about whether it will …
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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