Laboratories: Time to Transition back to Standard Clinical Diagnostics?
Has Test Pooling Lost Its Usefulness?

Daily COVID-19 testing in the United States dropped precipitously as the latest surge ebbed and vaccines made their way into the population. But has the need for testing also dropped? Or could the demand for testing return? The answers to those questions will shape the near-term future for testing labs as they decide what investments to make in their operations.

Demand for Testing Drops

Laboratories LIMS

The good news across America is that the winter surge in COVID-19 cases has ended. The number of daily new cases averaged more than 200,000 in January and now fluctuates between 50,000 and 70,000 in early March.

After initial hiccups in distribution, vaccines from Moderna and Pfizer/BioNTech are rolling out to the population. In a March 2 briefing, White House Press Secretary Jen Psaki told reporters that the two companies are now shipping more than 15 million doses per week.

The newly-approved single-dose vaccine from Johnson & Johnson is also on the way. “Four million doses are already on trucks to different places in the U.S.,” Johnson & Johnson Chief Scientific Officer Paul Stoffels told Reuters. Another 16 million doses should ship by the end of March.

Vaccines are making their way into people’s arms. In an update to the White House press corps, the Biden Administration’s senior advisor on COVID-19, Andrew Slavitt, said that more than 82 million Americans, including 55% of those age 65 or older, had received at least one dose.

The declining infection rate, more resources being allocated to vaccinations and a harsh winter have combined to reduce testing significantly. By early March, the number of new tests had declined 28% from a mid-January peak of two million tests per day.

Laboratories: Time to Transition back to Standard Clinical Diagnostics?

Need for Testing Persists

Need for Testing Persists

Although it looks like the United States and the world may have turned the COVID-19 corner, the need for testing has not gone away. Vaccines are being administered, but only 9% of Americans are fully vaccinated with vaccination rates varying from less than 8% in Texas to more than 15% in Alaska. Medical experts believe that herd immunity to SARS-CoV-2 will only emerge by vaccinating around 80% of the population. “Really getting that last push to get to herd immunity is going to require convincing a lot of folks who are hesitant to get a vaccine,” Anand Parekh, chief medical adviser for the Bipartisan Policy Center, told The Hill.

Unfortunately, a large part of the population remains hesitant. A recent Pew Research survey found that 31% of Americans do not plan to get the vaccine. If public awareness campaigns cannot convert the vaccine-hesitant, then the coronavirus will continue to thrive and mutate. Dr. Anthony Fauci at a recent White House press briefing said, “A high baseline level of community spread of virus favors mutations and the evolution of variants.”

The CDC is already tracking several variants of interest that seem to spread more rapidly than the original coronavirus. The B.1.1.7 variant first appeared in the UK, the P1 variant in Brazil and the B.1.351 variant in South Africa. All three have been detected in the United States.

Several home-grown SARS-CoV-2 variants have also emerged. In New York City, the B.1.526 variant rose from 5% of cases to 12% within a month. The B.1.427 and B.1.429 variants began spreading during California’s surge. “Testing and sequencing is needed to localize and quarantine any infected individuals to prevent further propagation of the variant virus into the population,” virologist Michael J. Buchmeier with the University of California, Irvine told the Washington Post.

What Should Labs Do?

What Should Labs Do?

With the declining demand for COVID-19 tests, laboratories may consider winding down their coronavirus testing services. Their business would be better served by reassigning staff and resources to more productive services. However, this may not be the best way for labs to serve their communities. The risks of variant-driven surges are not certain, but they are real. The potential for even more testing demand could already be building.

At the same time, keeping options open requires testing labs stay current on the latest developments in COVID-19 testing. In the first two months of 2021 alone, the Food and Drug Administration issued 58 new Emergency Use Authorizations for SARS-CoV-2 molecular diagnostic tests.

COVIDLiMS Supports Both Options

Laboratories: Time to Transition back to Standard Clinical Diagnostics?

With so much uncertainty over the pandemic’s future, laboratories need to keep their options open. Unfortunately, labs are often constrained by inflexible systems that cannot be changed quickly or affordably in response to changing requirements.

Many testing labs have adopted COVIDLiMS from LabLynx, Inc. to support their COVID-19 testing services. Pre-loaded with configurable COVID-19 assays, workflows and reports, COVIDLiMS adapts to the way laboratories work. New tests integrate easily into laboratory processes. And a COVIDLiMS deployment can be completed in as little as a week.

When the pandemic declines to the point where your lab no longer needs to offer COVID-19 testing services, COVIDLiMS will continue to enhance your lab’s productivity. This LabLynx solution is based on its ClinDx clinical diagnostics LIS (Lab Informatics System) and can support all other clinical diagnostics orders and assays.

Whether your lab sees growing or shrinking demand for COVID-19 testing, the improvements to throughput, accuracy and turn-around times COVIDLiMS provides will continue to enhance your lab’s productivity far into the future. To learn more, visit covidlims.com or contact LabLynx at sales@lablynx.com or 866-LABLYNX (522-5969).

Laboratories: Time to Transition back to Standard Clinical Diagnostics?

References:

“National Data: Testing”, The COVID Tracking Project.

“Press Briefing by Press Secretary Jen Psaki, March 2, 2021”, The White House.

“Press Briefing by White House COVID-19 Response Team and Public Health Officials”, The White House, March 2, 2021.

“Press Briefing by White House COVID-19 Response Team and Public Health Officials”, The White House, March 5, 2021.

“J&J COVID-19 vaccine shipping to U.S., but new deliveries hinge on regulators”, Reuters.

“Plunging Demand for COVID-19 Tests May Leave US Exposed”, Medscape.

“COVID-19 Vaccinations in the United States”, US Centers for Disease Control and Prevention.

“Team Biden surprises with positive vaccine news”, The Hill.

“Growing Share of Americans Say They Plan To Get a COVID-19 Vaccine – or Already Have”, Pew Research Center.

“Multitude of coronavirus variants found in the US — but the threat is unclear”, Nature.

“New research shows California coronavirus variant is more transmissible”, Washington Post.

“In Vitro Diagnostics EUAs”, US Food and Drug Administration.

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