Supply Chain Issues Continue to Impact Labs Providing SARS-CoV-2 Testing, Finds AMP Survey

AMP’s 67-question anonymous survey assessed many important aspects of SARS-CoV-2 molecular diagnostic testing, including methodology, performance, capacity, supply chain, regulatory, and reporting requirements.

The preliminary results of the survey, which included feedback from 118 representatives from US-based academic medical centers, commercial reference laboratories and community hospitals, indicated that 85% of the respondents are currently offering SARS-CoV-2 testing to patients, while another 10% are currently in the test validation phase. 90% of the laboratories recognize the need to increase diagnostic testing capacity further, and they are working hard to make this happen in the next few months. However, more than 70% of these laboratories have experienced supply chain interruptions that have resulted in significant delays, in many cases forcing them to validate at least three different diagnostic testing methods at the same time just in case the supply of reagents or materials runs out. These supply shortages have included everything from the RNA extraction kits, primers, probes, and enzymes to the physical sample collection materials, such as the swabs and containers for storage and transportation.

“Clinical laboratories across the country are working hard and being extremely resourceful in order to provide diagnostic SARS-CoV-2 testing to Americans, with the majority running at full staffing/testing capacity seven days a week,” said Karen E. Weck, MD, AMP President and Professor of Pathology and Laboratory Medicine, Professor of Genetics and Director of Molecular Genetics and Pharmacogenomics at University of North Carolina Chapel Hill. “However, AMP members know more testing is needed as the country begins to reopen. We are continuing to deploy multiple testing methodologies to overcome supply shortages, increase capacity and improve turnaround times.”

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Association for Molecular Pathology (AMP)