A national strategy is needed to provide greater clarity and transparency about existing COVID-19 testing capacity and the supply chain for testing supplies, as well as to help ensure that states have the testing resources they need, the AMA said in a letter to Brett P. Giroir, MD, the Health and Human Services (HHS) assistant secretary for health and an admiral in the Commissioned Corps of the U.S. Public Health Service.

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Specifically, the letter told Dr. Giroir about the AMA’s concerns regarding the current state of diagnostic testing, access to testing components, and ensuring that laboratories have adequate resources—this includes being prepared for a potential resurgence of COVID-19 this autumn.

The AMA is appreciative of Dr. Giroir’s willingness to collaborate on the issue of access to diagnostic testing services, but other concerns were also raised, including issues about the performance of serological tests currently on the market and their use by the public to inform physical distancing decisions.

“As we anticipate the threat of COVID-19 may persist into the fall, the coming months represent a critical time for federal leadership to help ensure states are adequately resourced and prepared with critical strategies to manage what may be increased demand for testing services,” AMA CEO and Executive Vice President James L. Madara, MD, wrote in the letter.

To ensure diagnostic testing is available to all who need it and that laboratories can handle the persistent and intense demands placed on them by the pandemic, the AMA made the following recommendations:

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Pursue a national strategy for testing during the COVID-19 pandemic. Many labs, including hospital, academic, and community labs, continue to struggle to provide ready access to tests. This is due, in a large part, to inconsistent and constrained availability of critical testing components. The challenges created by the overwhelming global demand are understood. But the AMA believes strong federal guidance can create better clarity on where testing capacity exists and how to best manage local and regional resources.

Consult with hospital, academic and community labs. Laboratories continue to play a vital role in the diagnosis and management of patients with COVID-19—particularly hospital labs that inform rapid diagnosis for triage and patient placement decisions. These labs, however, experience significant challenges including, the AMA has heard, the federal government requisitioning ordered supplies with little explanation as to where or why those supplies are being diverted. The AMA strongly recommends the administration receive regular input from the hospital, academic, and community laboratories, which the AMA would be pleased to help facilitate.

Ensure laboratories have adequate resources to meet demand. The AMA understands there are significant supply-chain issues, but labs must have adequate resources. This includes test components, plus adequate personal protection equipment for lab workers and a robust workforce. The AMA strongly encourages the administration to consider what actions can be taken to do this, and the AMA supports, where appropriate, invoking the Defense Production Act to ensure consistent supplies of test kits, reagents, transport media and swabs.

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Provide additional guidance and education to physicians and the public regarding serological testing, its performance limitations, and the risk for false positives. The AMA has growing concern over the performance of many of these tests for SARS-CoV-2 antibodies coming to market. The AMA would be happy to help amplify such guidance to labs, patients, and physicians, Dr. Madara wrote.

Physicians can stay up to date on all of the AMA’s COVID-19 advocacy efforts and track the pandemic with the AMA's COVID-19 resource center, which offers a library of current resources from the JAMA Network™, the Centers for Disease Control and Prevention, and the World Health Organization.

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