ROCKVILLE, Md. - May 28, 2020 - The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, today released the preliminary results of its April 2020 SARS-CoV-2 Testing Survey for clinical laboratories. The anonymous survey was created and administered to document clinical laboratory efforts and experiences. The results will be used to help inform future advocacy and clinical practice programs related to pandemic responses.
AMP's 67-question 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 today included feedback from 118 representatives from US-based academic medical centers, commercial reference laboratories and community hospitals. 85% of these 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."
Based on the common themes found in the survey results, AMP is recommending that federal, state and local governments:
1. Reassess type and location of SARS-CoV-2 testing services needed: In order to provide acute care, safely reopen businesses and reinvigorate the economy, there should be a reassessment of what type of testing is needed and where.
2. Reprioritize supply allocations based on clinical testing needs, which could change over time: Depending upon the prevalence of SARS-CoV-2 in a community, there may be a shift in testing methodology and related supply needs over time. The need for testing supplies designed for acute care, surveillance, high-throughput, and other clinical needs should be monitored widely to provide real-time feedback to agencies to support data-driven supply allocations.
3. Increase transparency, communication, and real-time transmission of Information between laboratories and suppliers (commercial manufacturers and government): There is a need for laboratories to understand in real-time resource availability and reagent and supply quantities.
4. Real-time coordination amongst laboratories to leverage moments of excess capacity: Based on data regarding testing capacity and demand, there may be an opportunity to coordinate regionally to ensure that any excess test capacity is leveraged to ensure samples get processed as quickly as possible.
5. Standardize agency reporting format and processes for reportable infectious diseases during a pandemic: Complying with multiple agency reporting requirements with variable formats has been burdensome to the clinical laboratories.
AMP will continue to review and analyze the results of the survey as part of its ongoing commitment to share expertise, assess laboratory needs, engage key stakeholders and provide recommendations for improving future pandemic responses and ensuring more patients have access to high-quality testing procedures.