TAG:

lab tests

FDA Says 8 of 11 Tests Fail in Serology Test Review

This is an excerpt of a 1,970-word article in the June 22, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review,…

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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 tha…

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

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

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

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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COVID-19 Pandemic Erodes Cash Flow at Clinical Labs

This is an excerpt of a 1,209-word article in the June 1, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to man…

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COVID-19 Pandemic Erodes Cash Flow at Clinical Labs

CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to manage the COVID-19 pandemic. Recently, national news coverage has begun focusing on concerns about inaccurate or unreliable COVID-19 serology tests. But the story being…

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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…

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Coronavirus Tests Boost Immunology Lab’s Volume

CEO SUMMARY: Physicians treating patients with compromised immune systems who contract the new coronavirus need immunology tests to guide risk-assessment decisions for these patients. At a Virginia lab that specializes in such testing, specimen volume has tripled since the SAR…

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In Michigan, Short Supplies Constrain COVID Test Capacity

CEO SUMMARY: Because of a severe shortage of supplies, members of Michigan’s two hospital laboratory networks have been stymied in their ability to respond to the pandemic and operate their SARS-CoV-2 analyzers at full capacity. The lack of primers, reagents, specimen-collec…

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