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AMP Releases Second Preliminary SARS-CoV-2 Testing Survey Results

NEW YORK – The Association for Molecular Pathology announced the preliminary results of its SARS-CoV-2 molecular testing survey Thursday, which aimed to elucidate the issues that laboratories are facing during the COVID-19 pandemic.

AMP previously conducted a survey in April monitoring labs' response to the pandemic. According to the new survey, conducted in August and September, labs are continuing to face supply chain interruptions, but are also now experiencing significant staffing shortages, despite increasing demand for molecular diagnostic testing. 54 percent of the survey's respondents said testing demand was higher than capacity, due largely to the reopening of schools and businesses.

The 100-question survey requested information about sample types, patient populations, methodologies, validation, performance, supply chain, public health reporting, laboratory workforce, and reimbursement, AMP said in a statement. The preliminary results came from 113 representatives from academic medical centers, commercial reference laboratories, public health laboratories, and community hospitals. 

Most of the survey's respondents said they are running diagnostic testing, with 72 percent performing screening testing and 29 percent performing surveillance testing, and almost all of the respondents said they are using at least two testing methods to keep up with demand.

The top testing method being used among labs is Roche's Cobas SARS-CoV-2 test, followed by a general laboratory-developed testing procedure with submission to the US Food and Drug Administration for Emergency Use Authorization. Approximately 35 percent of the labs surveyed said their EUA submission took more than a month to make it through the FDA, and some had not received approval after four months. Thirty-two percent said they had experienced hurdles from the FDA while completing the EUA process.

Respondents said they anticipated further increases in testing demand as the flu season ramps up and as demand for surveillance and screening testing continues. 90 percent of the US laboratories said they plan to increase testing capacity over the next three months, largely by adding more platforms or tests.

In addition, 79 percent of labs surveyed said their turnaround times for their primary method of testing are less than 48 hours. 

Supply chain issues continue to significantly impact testing, with 90 percent of respondents saying supply chain interruptions have delayed or decreased testing, and testing kits and platform-specific laboratory consumables are the most needed items. Testing platforms and general consumables are also in short supply, respondents said. However, in contrast to the April survey, shortages in swabs and viral transport media have been less of a problem for most labs.

Almost 70 percent of the surveyed labs said they had been told by a supplier that they couldn't purchase testing kits or reagents due to government restrictions or allocations for the products. 

The staffing shortages and high demand for SARS-CoV-2 testing is also impacting testing for other diseases, respondents said. Fifty-five percent of respondents said the volumes for other tests had decreased during the pandemic, and 85 percent said they have experienced staffing shortages. Almost two-thirds of respondents said they have shortages in qualified clinical laboratory technologists and scientists, and 53 percent have shortages in clinical laboratory technicians.

As a result of both surveys, AMP is recommending that federal, state, and local governments ensure that regulatory requirements for clinical laboratories aren't duplicative or burdensome and support the clinical lab workforce by promoting better collaboration and communication between labs and relevant government agencies. 

The organization also reaffirmed five recommendations it made as a result of the April survey results, which included requesting governments reassess the type and location of SARS-CoV-2 testing needed, reprioritize supply allocations based on testing needs, and increase transparency and communication between labs and suppliers. AMP also recommended improving real-time coordination among labs to utilize moments of excess capacity and standardizing agency reporting format and processes for infectious diseases.