May 2020

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 compare the performance of 12 serological tests, and shared their results with …

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Helping Labs with Cash Flow, COVID-19 Response

ROUTINE SPECIMEN VOLUME REMAINS DOWN by 50% or more for clinical laboratories and anatomic pathology groups in the United States because of the pandemic. Through the end of last week, The Dark Report estimates that labs in the U.S. have lost almost $7 billion since the first week of March. That’s when patients stopped visiting their doctors and …

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FDA Replaces March 16 Serology COVID-19 Rules

Clinical Laboratory / By Joseph Burns

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 lack of oversight under the March 16 rules, the market was flooded with tests, including some …

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Expert Offers Comments on FDA and Revised Serology Test Rules

Clinical Laboratory / By Joseph Burns

CLINICAL LABORATORY DIRECTORS are asking what caused the federal Food and Drug Administration (FDA) to issue a highly questionable policy in March to allow serological tests for SARS-CoV-2 and then change that policy seven weeks later. Under a policy the agency issued March 16, the FDA granted what it called “regulatory flexibility for developers offering such tests without FDA review and without an emergency use …

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New Lab Revenue Source: COVID-19 Worker Screening

Clinical Laboratory Trends / By Joseph Burns

CLINICAL LABORATORIES have a new revenue-generating opportunity, as some states relax stay-at-home rules: Many employers are likely to seek COVID-19 screening tests for employees returning to work to detect the presence of the new coronavirus. This new source of lab specimens and revenue gives clinical labs an opportunity to replace some revenue lost since early March. That is when routine daily specimen volume began to …

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California Research Team Analyzes Performance of 12 Serology Tests

Clinical Laboratory / By Joseph Burns

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 tests analyzed were 80% positive. Using donated blood samples, the researchers assessed the volume and …

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To Stay Afloat, Dallas AP Group Cut Staff, Payroll

Laboratory Management / By Joseph Burns

CEO SUMMARY: As early cases of COVID-19 spread in some states, pathologists at the 50-member ProPath group in Dallas prepared for a widespread outbreak by preserving cash and working with bankers and other advisors to apply for federal stimulus funding. Executives also furloughed pathologists and other staff temporarily before using federal funds to bring them back. Despite a 65% drop in …

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MAY 11, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Clinical laboratories in other countries have similar challenges in responding to the COVID-19 pandemic. In the United Kingdom, the Independent reported last week that “Widespread testing for coronavirus has been suspended among staff and patients at hospitals and GP practices serving 3.5 million people because of a shortage of vital chemicals.” According to Independent reporter Shaun Lintern, medical laboratories serving South London are unable to access adequate supplies of reagents and other …

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