The American Society for Microbiology (ASM), one of the largest life science societies in the world comprised of more than 30,000 members, expressed their concern in the following statement released today about the supply chain for critical components to execute diagnostics for novel Coronavirus Disease 2019 (COVID-19).
Clinical microbiologists and clinical labs are an essential component of the response to COVID-19. The American Society for Microbiology (ASM) membership includes thousands of public health and clinical laboratory microbiologists who are on the front lines of testing for COVID-19. ASM is closely monitoring and working to address the challenges and barriers posed to these labs that have emerged in recent weeks.
One challenge that has come to light is the supply shortage for SARS-COV-2 PCR reagents. We are deeply concerned that as the number of tests increases dramatically over the coming weeks, clinical labs will be unable to deploy them without these critical components. Increased demand for testing has the potential to exhaust supplies needed to perform the testing itself. This could include chemicals or plastics, for example, and could affect tests developed and offered by clinical or public health laboratories and/or (when they become available in the United States), commercial tests. We applaud the CDC for revising their guidelines for COVID-19 testing on March 9, 2020 to collect one specimen swab instead of two. This will cut the amount of testing reagents needed in half, which is a critical measure to take during a public health emergency such as this.
However, we know from past experience that reagent shortages can persist, and we understand there are limits on how rapidly companies can realistically accelerate production of the necessary reagents. This is especially true when additional time is required for quality assurance and control. We urge the Food and Drug Administration, however, to continue to support the supply chain to the extent that it can and with existing authorities and funding.
This is also a moment where we need to establish good diagnostic stewardship, including coordinated, timely and accurate guidance on how to deliver the best patient care possible and protect the public. We appreciate the expanded testing criteria that CDC issued on March 8, 2020 to guide clinicians in deciding who should be tested based on risk, exposure and symptoms.
We commend Congress for providing urgently needed supplemental funding to address the COVID-19 outbreak in a swift and bipartisan manner. Beyond the immediate resource needs, the current coronavirus public health emergency illustrates the importance of sustained investments across multiple government agencies, including the CDC, NIH, ASPR and the FDA; and it underscores the need for regulatory flexibility, and for maintaining open and timely communication with the American public and with our international partners.
