How the delay in the U.S. Distribution of COVID-19 test kits early-on Impacted New York’s nursing homes

The Island Now

The pandemic was in full force last March 2020 when nursing homes across the country were caught off-guard by the deadly coronavirus.

The test kits that were badly needed early-on to detect the coronavirus in the skilled facilities were scarce. Making matters worse, the surge in COVID-19 cases caused a shortage of personnel staff and a lack of PPE for both residents and employees of the nursing homes.

Nationwide the virus and its consequences claimed the lives of an estimated 160,000 residents of long-term care facilities, approximately 1/3 of the deaths in the United States. The failure to provide substantial amounts of test kits throughout the U.S. laid with the bureaucracy in Washington, D.C.

The Centers for Disease Control and Prevention received emergency use authorization to develop a laboratory test kit to diagnose COVID-19. The test kit provided results within 4 hours, but the number of kits available were disproportionately lower than the growing cases of coronavirus in the United States.

At that time there were only about 200 kits being distributed nationwide testing approximately 700-800 patient specimens per kit. The International Reagent Resource, the CDC’s arm, was created to acquire and distribute reagent chemicals needed for the test kits to be used by diagnostic labs which separated the coronavirus’ genetic material.

But the manufacturing setback of test kits was precipitated by a decline of the supply of reagents. The primary manufacturer of the reagents needed for the COVID-19 tests was Qiagen located in Germany. Qiagen’s supply of the reagents had diminished because of the unexpected demand caused by the pandemic.

While the availability of test kits was scarce in the United States, most European countries had already manufactured their own kits. Europe experienced the widespread effect of the pandemic earlier than the United States, and by the end of February, 2020 researchers from around the world were producing test kits to detect COVID-19.

The World Health Organization had dispatched test kits to detect the novel coronavirus to over 60 countries, but not the United States. Why? The WHO’s list for distribution of test kits never included the United States since the U.S. had always had a laboratory network sufficient to counter most viruses.

But the novel coronavirus posed a different consequence and the Pan American Health Organization, headquartered in Washington D.C. focused on other countries that had a weaker virology laboratory system than the United States.

Even though the CDC’s protocol is to initiate diagnostics to counter new threatening bacterium that cause disease, there was a bottleneck in the production of test kits for the coronavirus.

Early on during the virus pandemic the CDC lab in Atlanta was the only lab in the United States that had the authority and capability to test for the novel coronavirus but was severely backlogged. In its defense, the CDC’s response to the backlog was “lab testing quality.” While the test kits were sent out to state labs throughout the country, including New York, they were recalled because of a reagent validation problem.

Theoretically state labs and hospitals throughout the United States had the capacity to carry out tests for the novel coronavirus, but FDA approval was withheld during the early months of the pandemic.

It was not until the very end of February 2020 that the U.S. Food and Drug Administration announced new guidance for emergency use approval of coronavirus tests not distributed by the CDC.

Between January and March 2020, the virus in its purest form spread from China and Europe making its way to the United States. The widespread need for testing in the early months of the pandemic of nursing home residents, staff and visitors never happened in most skilled facilities because of the scarcity of test kits.

The national failure of Washington D.C.’s bureaucracy to not foresee the urgent need for test kits early on in the pandemic and the pending delay in test kit distribution cost New York precious time. The consequences of which allowed the virus to multiply at an unprecedented rate.

Patricia Maher


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