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GAO Report Highlights Testing Data Challenges During COVID-19 Pandemic

NEW YORK – The US Government and Accountability Office released a report Thursday addressing the federal government's response to the ongoing COVID-19 pandemic and found that the testing data that has been reported to the US Centers for Disease Control and Prevention has been neither complete nor consistent.

The report outlined the variety of challenges that agencies within the US Department of Health and Human Services have faced regarding testing, including the accuracy and reliability issues with CDC's SARS-CoV-2 test, leading to testing delays in the early days of the outbreak. These delays "resulted in limited information on the spread of COVID-19 in communities," the GAO report said.

The CDC test was the first for detecting SARS-CoV-2 to receive Emergency Use Authorization from the US Food and Drug Administration. But several labs soon found problems with the test, which limited rollout of the test.

Throughout the course of the pandemic, the CDC has reported testing data provided by state and local public health departments, which received them from laboratories. As the pandemic has continued and testing has expanded, the report noted that the sources of data have also changed, since originally SARS-CoV-2 tests were only performed by the CDC and public health laboratories but has added data from clinical and commercial laboratories, as well. In March, the Trump administration sent a letter to hospitals requesting daily reports of testing data to HHS. Despite the increase in data, "as of May 31, 2020, testing data remained incomplete," according to the GAO. 

Some of the data not included would have come from tests performed by labs at point-of-care settings, like doctors' offices. Reporting this data will become more important "because HHS estimated point-of-care testing will grow to 25 million tests per month by September 2020," the report said.

The inconsistency of the data has also been a problem, according to the report. The sources of data have varied and have not been counting tests the same way, even though the CDC posted guidance in May on how clinical laboratories should submit data to states. The GAO report noted that if states didn't report data for a specific day, the CDC collected and reported the testing data from websites aggregating the data. However, some states' websites counted the number of people tested and other counted the number of samples tested, which could be different.

The CDC also reported states' testing data as viral load testing without realizing that some states' data included antibody tests as well as diagnostic tests and continues to report both types of tests together.

These testing issues have "made it more difficult to track and know the infection rate, mitigate the effect of infections, and inform decisions on reopening communities," the report stated.

Guidance from the HHS released earlier this month could help standardize and clarify the data, since the agency is now requiring labs performing COVID-19 diagnostic tests to submit additional data daily, including those on point-of-care tests and those identifying whether a viral or antibody test was performed. Labs must also report certain patient demographic information and submit the data using regional, state, or local submission methods, the guidance said.