CDC Overhauls Lab Operations in Response to Failed COVID Testing

In early February 2020, Kirsten St. George and her team at the New York State’s public health lab encountered a setback with the Centers for Disease Control and Prevention’s (CDC) diagnostic test for the rapidly spreading coronavirus. The test provided inaccurate results, necessitating the sending of samples back to the CDC for processing. This delay left state officials unaware of the true extent of the disease’s spread, hindering containment efforts.

According to an independent panel consisting of laboratory researchers, public health and policy experts, and doctors, the CDC’s flawed test was a significant misstep that impeded national efforts to control COVID-19. The panel identified various problems within the CDC’s laboratories, including a lack of unified leadership, inadequate planning and quality control systems for novel pathogen tests, and ineffective governance. This lack of foresight and expertise further exacerbated the situation.

To rectify these issues, the CDC is working to address its shortcomings based on the recommendations provided by the advisory committee. However, this task is complicated by new leadership, limited resources, and potential budget cuts from Congress. Failing to make significant changes could erode trust in the agency and harm preparedness for future public health emergencies.

The CDC’s original COVID test had two main problems: a design flaw and contamination during production, leading to false positive results. An internal analysis in 2021 and an independent postmortem conducted by the panel confirmed these shortcomings. As a consequence, public health agencies were slow to respond to the virus’s rapid spread, resulting in delayed recommendations and protective measures.

To prevent future failures in test development, the advisory group made ten recommendations for the CDC, including consolidating lab operations, separating research labs from clinical testing labs, and involving outside experts in reviewing tests for pandemic-related pathogens. Some of these suggestions have been implemented under the leadership of Rochelle Walensky and Mandy Cohen, but ongoing funding and a cultural shift within the agency remain key obstacles.

Funding challenges loom large for the CDC, with potential cuts to its budget that could impede implementing recommended changes. Physical separation of labs and ongoing training require sustained financial support. Additionally, the agency needs to foster a culture where scientists adhere to quality standards comparable to the larger laboratory community.

Failure to implement the recommendations may result in the CDC losing ground to commercial lab companies in developing diagnostic tests for new disease threats. While commercial labs operate on a larger scale, they prioritize profit over public health. The CDC, on the other hand, acts to understand emerging pathogens without the pressure of financial incentives.

The COVID-19 pandemic has highlighted the need for accurate and timely testing to address global public health threats effectively. The CDC plays a crucial role in developing tests to identify novel pathogens and track their spread. Ensuring the agency has the capacity to meet these demands is vital for our protection and preparedness.

KFF Health News, formerly known as Kaiser Health News (KHN), is a nationally recognized newsroom dedicated to in-depth journalism on health issues. It serves as one of the core operating programs at KFF, an independent source for health policy research, polling, and journalism.

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