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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 experts agreed that the test performs exceptionally well. Abbott Laboratories also reported high performance levels for its …

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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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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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DOJ Says Georgia Man Got Kickbacks for COVID-19 Tests

Laboratory Compliance / By Joseph Burns

JUST WEEKS AFTER THE FIRST CASES OF SARS-CoV-2 appeared in the United States, federal prosecutors filed criminal charges in a COVID-19 lab test fraud scheme. Erik Santos, 49, of Braselton, Ga., was charged with conspiracy to defraud federal and private healthcare programs by submitting fraudulent testing claims for COVID-19 and genetic cancer screenings. This may be a sign that federal healthcare investigators will …

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At the Epicenter, Northwell’s COVID-19 Lab Data Adds Value

Laboratory Management / By Joseph Burns

CEO SUMMARY: This intelligence briefing provides a valuable look inside a clinical laboratory that is at ground zero in a city and state that is experiencing the nation’s most intense and fastest-moving incidence of COVID-19, the novel coronavirus. Lab leadership granted The Dark Report access to its strategies and how it supports health system administrators, physicians and patients, and state andlocal health …

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At the Epicenter, Northwell’s COVID-19 Lab Data Adds Value

TDR Insider / By Joseph Burns

This is an excerpt of a 3,210-word article in the March 30, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: This intelligence briefing provides a valuable look inside a clinical laboratory that is at ground zero in a city and state that is experiencing the …

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Labs in Italy Moved Fast to Develop COVID-19 Tests

Clinical Laboratory / By Robert Michel

Part One in a Series ITALY HAS ONE OF THE WORLD’S SEVEREST OUTBREAKS OF COVID-19 INFECTIONS, based on the number of cases and the mortality rate. In response, clinical laboratories there moved quickly to launch laboratory-developed tests and to increase the volume of COVID-19 tests that they could run each day. For Mario Plebani, MD, Professor of Clinical Biochemistry and Clinical Molecular Biology …

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Drive-Up COVID-19 Test Site Launched in 3 Days

Clinical Laboratory / By Joseph Burns

CEO SUMMARY: After seeing the largest cluster of confirmed coronavirus infections in one location, New York State took emergency measures “to attack the hotspot at its source.” The state opened a drive-through specimen-collection site offering free testing without an appointment or doctor’s order. In partnership with two labs, Gov. Andrew Cuomo ordered the site be operational within three days. At one …

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COVID-19 Patient? Northwell Has Mobile Phlebotomy App

Clinical Laboratory Trends / By Joseph Burns

>CEO SUMMARY: What better way to limit the spread of a deadly novel coronavirus than to allow patients who suspect they have the COVID-19 illness to use a mobile phone to book an appointment with a phlebotomist who makes house calls? Northwell Laboratories started this service in November and now views this option as a …

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