Top News Stories for the Week of September 28

Global Partnership to Make Available 120 Million Affordable, Quality COVID-19 Rapid Tests for Low- and Middle-Income Countries

WHO News Release

The World Health Organization (WHO) and its partners announced Monday a program to supply low- and middle-income countries with affordable, high-quality COVID-19 antigen rapid tests. As part of the initiative, the Bill & Melinda Gates Foundation has inked separate volume guarantee agreements with Abbott and SD Biosensor that will make available 120 million antigen rapid diagnostic tests, priced at a maximum of $5 each, over a period of 6 months. The tests, which provide results in 15-30 min., will allow for the expansion of testing, especially in nations that do not have extensive laboratory facilities or trained health workers to implement PCR tests. Additionally, the Global Fund reports it has made an initial $50 million available from its COVID-19 Response Mechanism to help countries purchase at least 10 million of the new rapid tests at the guaranteed price. Unitaid and Africa CDC will combine resources to begin the roll out of the tests in up to 20 African countries starting this October.

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Under 10 Percent of Americans Have COVID-19 Antibodies, Study Finds

New York Times

Fewer than 10 percent of Americans have COVID-19 antibodies, according to research out of Stanford University. Based on analysis of blood samples from 28,500 dialysis patients nationwide, the scientists calculated that only 9.3 percent of the population is protected by antibodies, with wide variation by state. The findings, reported in The Lancet, indicate the United States is even further from achieving herd immunity than previously thought. They also line up with the results of a new Centers for Disease Control and Prevention (CDC) study being prepared for release. That research, according to an agency spokeswoman, revealed a seroprevalence rate of less than 10 percent after testing blood samples from 52 commercial laboratories this summer. According to a statement from CDC Director Robert Redfield, the studies suggest that most Americans should continue to protect themselves from infection by donning face coverings, washing hands often, practicing social distancing, staying home when ill, and "being smart about crowds."

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CMS Releases New Tools to Streamline Certification for Labs Testing for COVID-19

CMS Press Release

The Centers for Medicare & Medicaid Services (CMS) has issued new tools in an effort to reduce paperwork and authorization delays for laboratories seeking Clinical Laboratory Improvement Amendments (CLIA) certification to test for COVID-19. A quick-start guide assists labs with the CLIA certification application process, including the steps laboratories must follow to apply for and receive CLIA certification and information about the expedited review process that was implemented at the beginning of the public health emergency. In addition, labs can now pay CLIA certification fees on the CMS CLIA Program website, with online payments processed overnight. CMS Administrator Seema Verma said, "Today's announcement will allow testing laboratories to promptly and painlessly register with CMS so they can get to work, focusing on providing reliable information to combat the spread of this disease."

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