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COVID-19 Serology Test Review: FDA Says 8 of 11 Tests Fail

Only three of the COVID-19 serology tests with EUAs met the FDA’s published requirements when evaluated

CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review, as of this writing the FDA website lists only 77 serology tests. Of that number, 11 assays have been evaluated independently and eight of those 11 have been pulled from...

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Questions Arise as FDA Assesses Serology Tests

Federal lab is studying COVID-19 serology tests for the FDA, but little is known about this process

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 ...

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Health Insurers Push Back On COVID-19 Test Claims

Lawyer says payers are finding multiple ways to question claims from labs for coronavirus tests

CEO SUMMARY: Under new federal laws, health insurers are required to pay for testing for the novel coronavirus without cost-sharing, prior authorization, or medical management limits, but insurers are questioning these COVID-19 lab test bills and denying many of the claims, a healthca...

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Lab Buys More Instruments as Way to Add Test Volume

Health system lab adds five COVID-19 tests, orders new analyzers, but demand still outstrips capacity

CEO SUMMARY: Severe shortages of supplies for COVID-19 lab testing caused one lab director in the Midwest to buy additional instruments while also validating five different COVID-19 tests to run on analyzers the lab used before the pandemic hit. While this strategy allowed the lab to ...

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Where Is the FDA When Labs Need It Most?

LET'S START WITH AN ESSENTIAL FACT: in the management of almost every outbreak of a novel infectious disease, clinical laboratory tests will be essential in diagnosis of the disease, in monitoring the progress of an infected patient, and in determining if, once cured, a patient has immunity to that disease. Next, let’s recognize another basic fact: clinical lab test...

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