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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 design. The FDA evaluated serology assays using 110 samples from […]

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Lab Buys More Instruments as Way to Add Test Volume

Laboratory Equipment / Joseph Burns

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 bump up the number of COVID-19 tests it can perform daily, ongoing shortages of

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June 22, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

As they scramble to respond to the COVID-19 pandemic, federal officials in multiple agencies are purchasing equipment and supplies from vendors with dubious credentials and little operating history. In recent days, Pro-Publica reported “a fledgling Texas company was paid $7.3 million for test tubes needed in tracking the spread of the coronavirus nationwide. But, instead of the standard vials, Fillakit LLC has supplied plastic tubes made for bottling soda, which state

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Volume XXVII No. 8 – June 1, 2020

Mary Van Doren

THE DARK REPORT brings news that the national media has overlooked: Lab revenues, cut precipitously during the coronavirus pandemic, will leave many labs without the resources to continue operation in the near future. As calculated by THE DARK REPORT, the nation’s clinical lab industry had lost $6.8 billion in revenue by week 12 of the crisis. Also reported is that in many cases, the culprit is a frustrating lack of supplies that would allow labs to replace lost routine testing with new COVID-19 testing.

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Coronavirus Tests Boost Immunology Lab’s Volume

Clinical Laboratory / Joseph Burns

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 SARS-CoV-2 pandemic began. The lab does immunology testing for patients needing transplants, as well as for patients who have AIDS, cancer, diabetes, heart

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In Michigan, Short Supplies Constrain COVID Test Capacity

Clinical Laboratory / Joseph Burns

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-collection swabs, test kits, and viral transport media resulted from directives federal officials imposed in the supply chain in favor of

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Lab Directors Develop Plans for Return of Routine Hospital Care

Clinical Laboratory / Joseph Burns

CLINICAL LABORATORY DIRECTORS IN MICHIGAN are developing plans to test patients who will return when hospitals reopen for routine care. Included in those plans are strategies to do testing for the novel coronavirus on patients who will return for everyday care and elective procedures, said Barton P. Buxton, EdD, President and CEO of McLaren Health Management Group. MHMG provides laboratory and other services in

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June 1, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Daily, national news headlines call attention to the lack of adequate testing for COVID-19. News reporters question why clinical labs are unable to meet the demand for SARS-CoV-2 tests. One major reason is the lack of adequate supplies labs need to collect specimens, transport them, and perform COVID-19 tests in large numbers. This is one finding of a study conducted by the Association for Molecular Pathology (AMP). In a press release

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Volume XXVII No. 7 – May 11, 2020

Mary Van Doren

LABS CAN REST EASIER knowing that the initial flood of unvalidated faulty or fraudulent serological COVID-19 tests is being halted now that the FDA has done an about-face on its policies. And THE DARK REPORT offers behind-the-scenes insights into the COVID-19 Testing Project which used a multidisciplinary effort to analyze and compare the performance of 12 of these tests. In other good news, THE DARK REPORT reports on a potential new revenue source for cash-strapped labs.

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California Research Team Analyzes Performance of 12 Serological Tests

TDR Insider / Joseph Burns

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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