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AMP SARS-CoV-2 Molecular Dx Survey Shows Supply Chain Issues Hampered Ramp Up of Testing

NEW YORK – The Association for Molecular Pathology (AMP) on Thursday released the preliminary results of its April SARS-CoV-2 testing survey for clinical laboratories, showing that while labs recognize the need to increase diagnostic testing capacity, a significant portion of them have experienced interruptions in their supply chains that have slowed down their ability to offer efficient testing programs to patients.

AMP's 67-question survey was created to document clinical lab efforts and experiences. It assessed many important aspects of SARS-CoV-2 molecular diagnostic testing, including methodology, performance, capacity, supply chain, regulatory, and reporting requirements. The preliminary results include feedback from 118 US-based academic medical centers, commercial reference labs, and community hospitals, AMP said.

Labs began developing tests quickly once they were given the regulatory green light, AMP found. Academic medical center labs reported an average go-live date of March 21 for their first test, but the earliest lab went live on Feb. 24. Most community hospitals/health system labs and commercial reference labs launched their SARS-CoV-2 testing approximately two weeks later, on average.

According to the survey results, 85 percent of the respondents are currently offering SARS-CoV-2 testing to patients, and another 10 percent are currently validating tests. Almost all of the respondents, 90 percent, said they recognized the need to increase diagnostic testing capacity further, and were working to make this happen in the next few months. When laboratories were asked how they plan on increasing their capacity, more than 80 percent said they plan to add more platforms or tests to reach desired capacity, or to increase their workforce and/or lab shifts.

However, more than 70 percent of these labs had supply chain interruptions. In many cases, these interruptions forced them to simultaneously validate at least three different diagnostic testing methods in case they ran out of reagents or materials.

The supply shortages have included everything from RNA extraction kits, primers, probes, and enzymes to physical sample collection materials, such as swabs and containers for storage and transportation, AMP said. More than 40 percent of academic medical center and community labs reported currently experiencing test kit supply interruptions, but only 13 percent of commercial labs said they were currently experiencing the same issue.

AMP also noted that approximately half of all labs surveyed reported that they'd been informed by a manufacturer or supplier that they could not purchase testing kits or reagents because of government restrictions and/or allocations for these products — approximately 60 percent of academic medical center and community hospital labs reported this circumstance compared to about 30 percent of commercial reference labs.

AMP also surveyed the respondents to determine their primary testing methods. About 21 percent said lab-developed testing procedures with US Food and Drug Administration Emergency Use Authorization submission was their primary testing method, followed by 17 percent who said they used Roche's Molecular Systems cobas SARS-CoV-2 assay, and 16 percent who said they used Abbott's Molecular RealTime SARS-CoV-2 assay as their primary testing method.

In terms of turnaround time for their primary method of testing, 43 percent of labs reported turning results around predominantly between 12 and 24 hours while another 34 percent reported a turnaround time of 24 to 48 hours. Almost half of academic medical centers reporting a turnaround time of less than 12 hours, AMP added.

Based on the preliminary results, AMP made several recommendations for federal, state, and local governments. First, they should reassess the types and locations of SARS-CoV-2 testing services needed in order to provide acute care, safely reopen businesses, and ensure that testing is where it's needed.

Second, AMP said, governments should reprioritize the allocation of supplies based on clinical testing needs, which could change 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.

Third, governments should help to increase transparency, communication, and real-time transmission of information between labs and their suppliers, so that labs can understand in real time what resources are available.

AMP also recommended that there be real-time coordination among labs to take advantage of moments of excess capacity, and to ensure that samples get processed as quickly as possible. The association also recommended that agency reporting formats and processes be standardized in order to lift some of the burden from clinical labs.