COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

New Updates to FDA Resource Page Provide Valuable Serology Test Information for Clinical Laboratories

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FDA serology testing resource page helps clinical laboratories understand the predictive value of tests based on localized prevalence

The US Food and Drug Administration (FDA) recently released a series of updates to the EUA-Authorized Serology Test Performance page on the FDA’s website. This page is intended to serve as a resource for clinical laboratories and other clinicians regarding the various COVID-19 serology tests that are available.

The FDA’s most recent updates, made available April 28, 2021, provide information on the expected negative and positive predictive values of each authorized COVID-19 serology test for various SARS-CoV-2 prevalence assumptions that range from 5% to 50%. This information is designed to help healthcare providers interpret the results of COVID-19 antibody tests and help their patients to better understand the implications of their results.

The updates to the website also clarify the role of serology tests in assessing a patient’s adaptive immune response as COVID-19 vaccination becomes more prevalent throughout the United States.

There are 78 serology tests that are currently listed on this FDA resources page, with the sensitivity and specificity of each test listed in addition to its targets, the technology that it uses, and links to multiple test fact resources. Clinical laboratory leaders wanting to access this free FDA resource can do so here.

Related Resources:

COVID-19 TESTING DATA

Helping Your Lab Stay Afloat During Challenging Times

Dear Colleague,

Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

We’ve added analysts, writers and skilled editors to the COVID-19 STAT team to uncover, analyze, and immediately report to you what’s happening with the SARS-CoV-2 pandemic, packaged with the insights you need to deliver quality testing for patient care and keep your lab’s financial ship afloat. As part of our mission, we are also bringing you real-time data from our partners around testing that you will not find anywhere else.

Please let me know how we can better improve this service to fit your needs. If you would like to offer a grant to keep our mission going with this site, please contact me at rmichel@darkreport.com.

Sincerely,

Robert L. Michel
President, Founder
The Dark Intelligence Group