A national survey of clinical diagnostic laboratories found more than 85% of respondents have seen shortages of testing supplies that hindered their responses to the COVID-19 pandemic.
This includes kits, chemicals and reagents for extracting the novel coronavirus’s RNA for analysis as well as the physical materials needed for collecting and transporting samples such as swabs and their containers.
Conducted over the month of April by the Association for Molecular Pathology (AMP), the survey polled 118 academic medical centers, commercial labs and community hospitals—85% of which were already offering coronavirus testing services, while 10% were still working to validate their tests.
In fact, many labs were forced to spend extra time and effort in the validation phase. Among those who reported supply chain interruptions, the survey noted several cases where organizations were forced to validate at least three different testing methods to provide backup options in case stocks ran out.
At the same time, 90% of labs agreed with the need to further increase the nation’s capacity for COVID-19 diagnostic tests, the association said.
"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 (PDF) AMP President Karen Weck, a professor and director of molecular genetics and pharmacogenomics at the University of North Carolina at Chapel Hill.
"However, AMP members know more testing is needed as the country begins to reopen,” Weck added. “We are continuing to deploy multiple testing methodologies to overcome supply shortages, increase capacity and improve turnaround times."
Just over half of respondents said they were told by manufacturers or suppliers that they could not purchase testing kits or reagents due to government restrictions or allocations of those products—this includes 60% of academic centers and community hospitals, compared to 30% of commercial labs.
The largest number of respondents, at 21%, said their primary method of testing was a laboratory-developed test submitted to the FDA for review; the next highest listed high-throughput tests from Roche, at 17%, and then Abbott's, at 16%.
Cepheid’s Xpert Xpress test—a 45-minute, point-of-care test authorized in March—was the most commonly reported backup, with 19% reporting it as their secondary test and 25% listing it as a tertiary option.
Based on the survey, the AMP recommended governments and public health organizations reprioritize supplies based on local testing needs, which evolve over time based on the prevalence of the coronavirus within the community. In addition, the association said labs should coordinate to share any excess testing capacity.