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AMA Recommends Steps to HHS to Improve SARS-CoV-2 Testing

NEW YORK – The American Medical Association on Monday submitted a letter to the US Department of Health and Human Services offering recommendations to improve SARS-CoV-2 testing capabilities.

The organization said in the letter – addressed to HHS Assistant Secretary for Health Admiral Brett Giroir – that it has concerns about the state of diagnostic testing in certain areas, access to supply materials, and adequate resources for laboratories, especially in the case of a resurgence in SARS-CoV-2 cases in the fall, as some forecast. The AMA also noted its concern about the reliability of serological tests for SARS-CoV-2 on the market.

According to the letter from AMA Executive VP and CEO James Madara, non-commercial laboratories are still struggling to provide enough testing services, and more can be done by the federal government to offer information on the supply chain, federal actions to secure testing supplies, and areas where testing capacity is highest. "The AMA believes there is additional opportunity to provide greater clarity and transparency around existing testing capacity and where that capacity is located to help states best manage local and regional resources, as well as provide strong federal guidance on how best to do so," Madara wrote. 

Related to the widespread supply issues, the AMA urged the Trump administration to consider actions to increase supplies of personal protective equipment and testing supplies, including invoking the Defense Production Act to increase manufacturing of test kits, reagents, transport media, and swabs.

He added that continued focus on preparation was essential to ensure patients are able to access diagnostic tests in case of a potential surge in cases during the next influenza season.

The letter also noted that hospital and academic labs have faced challenges securing testing supplies, partially because the federal government has requisitioned them with little explanation. As a result, the AMA recommended the agency receive regular input from members of the hospital and academic lab community. Earlier this month, the HHS Inspector General released a report detailing severe testing supply shortages at hospital labs.

There have been concerns surrounding the performance of serological tests coming to market testing for SARS-CoV-2 antibodies. The AMA said the federal government should offer additional guidance and educational materials about serological testing and recommended the tests be limited to use in epidemiological studies or by professionals trained in interpretation of serological results. The organization added that the public should be warned about limitations of serological tests, including the chances of false positives.