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

FDA maze of regulations

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.

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