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APHL Developing System to Improve OTC COVID-19 Test Result Reporting


NEW YORK – With support from the US National Institutes of Health, the Association of Public Health Laboratories is developing infrastructure to collect and distribute results from home COVID-19 tests, helping to address what has largely been a blind spot throughout the pandemic.

Last month, the organization received from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) a three-year grant totaling up to $8.8 million, which it is using to apply its cloud-based AIMS+ (APHL Informatics Messaging Service) data platform to home COVID-19 result reporting.

The development indicates a move within the diagnostics and public health communities to begin more systematically addressing the issue of data reporting for over-the-counter tests, a matter that has received limited attention amidst the scramble to build sufficient OTC testing capacity.

"I think at the beginning [of the pandemic] we just needed tests," said Mara Aspinall, professor of practice in biomedical diagnostics at Arizona State University and an adviser to the Rockefeller Foundation. "But now that we have a little bit of a pause, people are looking at the fact that [OTC] might be the new way to test, and so we need to have more data on how these tests are being used and the results."

The goal of the APHL project is to develop data standards and processes that will allow commercial test manufacturers to upload test data from their apps to the AIMS+ system, which will then distribute that data to the federal government as well as state or local entities that want it, said Patina Zarcone, director, AIMS+ informatics at APHL.

"We are integrating our platform with the different test kit manufacturers and reporting the data that comes through their apps," she said.

AIMS+ is the organization's secure data platform, which it uses to handle various kinds of public health data, transmitting, for instance, flu testing results from local public health labs to the US Centers for Disease Control and Prevention, or sequencing data between participants in the CDC's Advanced Molecular Detection program. The platform is meant to serve as a central link between various public health stakeholders, allowing them to connect with each other without having to maintain a series of individual linkages.

In addition to enabling the transfer of data between vendor apps and governmental and public health entities, APHL is also handling aspects of data validation and completeness, Zarcone said.

"We validate those data to make sure we have the elements within a message that are required to make the information actionable by public health," she said.

Bruce Tromberg, director of the NIBIB and leader of the RADx Tech program, noted that the development of tools and standards for OTC test reporting has lagged behind work in other parts of the larger COVID-19 testing ecosystem.

"Shockingly, there hasn't been a data standard for home testing, and this is absolutely important from a public health point of view," he said. "In March there will probably be a billion [home] tests that will be out either for free or in retail, and we've done hundreds of millions of tests over the last couple of months. So, that is the dominant testing pathway."

He added that reporting of home testing results could also play a significant role in accessing antiviral treatments in the future.

"If we can optimize the information transmission so that people can test at home and then be able to do telehealth … and then immediately be able to start in on treatment, that can significantly interrupt the chain of transmission of a disease," Tromberg said.

Currently, however, interfaces for information transmission are "the Wild, Wild West," he said.

Most OTC COVID-19 tests available in the US include downloadable apps that can be used to report test results, but there are questions around how frequently and reliably individuals using OTC tests will report results from those tests.

In its most recent COVID-19 data reporting FAQ, CDC noted that there "are no current mechanisms that require reporting of self-test results to public health authorities" and, consequently, there are "currently limited use for collection self-test result data to inform public health surveillance."

The agency added that "voluntary reporting of self-test results will often be anonymous or lack data necessary for public health analysis or action" and that these results "are unlikely to enhance understanding of trends in disease transmission or severity and often do not provide sufficient information to support case investigations."

In a recent article in Health Affairs, Tromberg and colleagues looked at data on self-reporting collected as part of the NIH and CDC's Say Yes! COVID Test, an initiative studying the usage patterns and effectiveness of COVID-19 home tests.

The researchers found that users recorded results in the companion app for less than 1 percent (8,905) of the more than 1.4 million OTC tests distributed. Of those results recorded in the companion app, 82 percent were reported by the users to the relevant department of health.

As the authors noted, this low level of reporting tracks findings from other countries. In the UK, for instance, results were returned for just 14 percent of the 691 million lateral flow tests distributed by the government as part of its COVID-19 response plan.

Aspinall said individuals would need to be incentivized somehow to report results. She suggested as possible routes the ability to use positive results to get access to treatment or, if, in situations where reimbursement is available for OTC tests, having payors require users to report results in order to be reimbursed.

Zarcone said that the NIH-funded APHL effort is taking COVID-19 as its starting point but is intended to prepare more generally for a world where OTC tests comprise a larger proportion of clinical tests for other illnesses.

"I think going forward we need to build an entire system around what should home testing look like," Aspinall said, adding that the current moment, with COVID-19 rates relatively low across the US, is an ideal time to begin putting systems in place for OTC test reporting.

"We can't wait until the next public health crisis to talk about this," she said.