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Search Results for: COVID-19

Labs May Qualify for Relief Under New Federal Laws

Clinical Laboratory Trends / Joseph Burns

CEO SUMMARY: After routine testing and specimen volume declined last month, so too did the associated revenue. In response, clinical laboratories and anatomic pathology groups want to bolster their finances quickly or risk incurring more financial damage to already-fragile balance sheets. Under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, and other stimulus plans from Congress, labs and pathology groups may […]

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Italy’s SARS-CoV-2 Outbreak Brings Out Best in Clinical Labs

Clinical Laboratory / Joseph Burns

CEO SUMMARY: Italy was one of the first countries outside of China to experience an explosive outbreak of COVID-19 and its northern provinces were hit hardest by this novel coronavirus. In this exclusive interview with THE DARK REPORT, internationally-known pathologist Mario Plebani, MD, discusses how his clinical laboratory in Padova responded to the pandemic in the Veneto Region. Second of

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Chicago Lab Launches LDT, Finds 20% Positive

Clinical Laboratory / Joseph Burns

CEO SUMMARY: After seeing the novel coronavirus spread quickly in China, staff in the Department of Pathology and Laboratory Medicine developed a test to identify the pathogen in patients in Chicago and its suburbs. With the CDC’s assay in hand, it started work on its own lab-developed test. In early April, the lab tested more than 10,000 patients and approximately 20%

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APRIL 20, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Not only did the outbreak of SARS-CoV-2 in the United States show how unprepared the nation was for an event like this, but it exposed numerous problems and weaknesses in the federal agencies tasked with protecting the health and safety of the American public. One high-profile failure happened when the Centers for Disease Control and Prevention (CDC) shipped defective COVID-19 test kits to public health laboratories in early February. It

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March 30, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Should consumers be allowed to collect their own specimens for a COVID-19 test? At least five companies announced plans in mid-March to sell COVID-19 tests directly to consumers and have them collect their specimens at home, then return the samples to the the labs doing the testing. This scheme came to a quick end, however, on March 20 when the federal Food and Drug Administration (FDA) issued an alert to

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Regulators Acted Slowly as Labs Developed Tests for Coronavirus

Laboratory Compliance / Joseph Burns

WHEN THE FIRST DEATHS FROM THE NOVEL CORONAVIRUS were reported in Seattle beginning on Feb. 29, Helen Chu, MD, MPH, took notice. An infectious disease expert at the University of Washington School of Medicine, Chu is a director with the Seattle Flu Study. Since late last year, researchers for the study have collected 2,500 flu samples from Seattle residents. On Feb. 25, Chu

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In New York, Lab Offers Mobile Virus Sample Collections

Clinical Laboratory / Joseph Burns

CEO SUMMARY: To allow patients and physicians to order at-home specimen collections of the novel coronavirus, Northwell Labs trained its 12-member mobile phlebotomy service in the procedures needed to collect samples using nasopharyngeal (NP) swabs. Since training occurred in the second week of March, demand has increased steadily from one to two calls per day to five to 10 requests daily.

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Providers Get Creative as FDA Clears More IVD Firms’ Tests

Clinical Laboratory / Joseph Burns

CEO SUMMARY: Clinical and molecular test laboratories, hospitals, public health agencies, and other providers are taking unusual measures to expand the number of tests available to identify the spread of the new coronavirus. When a hospital needed funding to buy test kits for the disease, the president of the facility used his own personal funds. When two residents of a resort

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This Coronavirus Outbreak Will Change Lab Industry

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: COVID-19 is causing a level of global disruption not seen since the influenza outbreak of 1918. This new infectious disease exposes flaws in the strategies and planning of public health officials and governments in the United States and abroad. In this country, news media quickly recognized that the unavailability of clinical lab tests for COVID-19 was primarily because healthcare

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Lab at the Epicenter of NY’s Coronavirus Pandemic

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

TODAY, THE NOVEL CORONAVIRUS PANDEMIC DOMINATES the daily activities of every clinical laboratory in the United States. The emergence of COVID-19 has triggered unprecedented actions by governments in different nations throughout the world. Within this country, all 50 states reported SARS-CoV-2 infections. But it is New York State that was hit hardest early in this pandemic. Until recent

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