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FDA Authorizes Use Of Batch Testing for COVID-19 As Labs Hit Major Delays

July 20, 2020 by Gaspard Le Dem
FDA Authorizes Use Of Batch Testing for COVID-19 As Labs Hit Major Delays

The Food and Drug Administration on Friday authorized Quest Diagnostics, an American clinical laboratory, to start processing COVID-19 tests in batches in an effort to speed up testing amid a nationwide surge in coronavirus cases.

The technique, called specimen pooling, allows labs to test several vials at once by combining them into a small group while keeping individual samples intact. 

The concept is simple. If the batch results come back negative, all patients are assumed to be virus-free. However, if the batch tests positive, each sample must be re-tested on an individual basis. 

Batch testing or “pooling” is routinely used by blood banks to quickly screen large numbers of blood samples for a variety of viruses. Assuming that a majority of batches come back negative, it has the potential to save labs precious time and resources while increasing testing efficiency. 

Experts say batch testing would be particularly useful in areas where cases remain relatively low. 

“As COVID-19 continues to spread around the country, access to timely, quality laboratory testing is critical to patients and an effective public health response,” said Steve Rusckowski, CEO of Quest Diagnostics, in a statement. “Pooled specimen testing is a proven technique that will help us to optimize testing capacity at this critical time for our country.”

In recent weeks, testing times have slowed to a grind as demand skyrockets across the country. Last week, Quest Diagnostics said that its average turnaround time had increased to seven days or more for all but its highest priority patients. 

Despite doubling testing capacity to 125,000 diagnoses per day, the company has struggled to keep pace with a rapid spread of infections in nearly every U.S. state. 

In total, 47 states and the District of Columbia are seeing an increase in cases. U.S. health officials reported more than 75,000 new COVID-19 cases in a single day on Friday, a record since the country started battling the outbreak, according to a New York Times database. 

In Asia and Europe, several countries have been using batch testing for months. In the Chinese city of Wuhan, where epidemiologists say the coronavirus outbreak started, health officials used the novel strategy to test more than 6.5 million people in a matter of days.

Many experts, including top health officials in the Trump administration, have called on the U.S. government to authorize the use of batch testing for months. “If you look around the globe, the way people are doing a million tests or 10 million tests is they’re doing pooling,” said Deborah Birx, the White House coronavirus response coordinator, at a conference last month. “Pooling would give us the capacity to go from a half a million tests a day to potentially 5 million individuals tested per day by those poolings.” 

According to the Centers for Disease Control, the U.S. has so far tested more than 47 million people, or roughly 14% of its population.

But critics say that slow turnaround times have rendered much testing useless as delayed results have failed to provide health authorities with an accurate snapshot of the virus’ spread.

Colorado Gov. Jared Polis, who last week issued a statewide mask mandate, called U.S. testing “a complete disgrace” on Sunday in an interview with NBC News. “Every test we send out to private lab partners nationally — Quest, LabCorp — seven days, eight days, nine days, maybe six days if we’re lucky,” Polis said. “Almost useless from an epidemiological or even diagnostic perspective.”

Meanwhile, President Trump has repeatedly argued that the U.S. has “the best testing in the world”, a claim that has been debunked by epidemiologists.

The White House is reportedly trying to block billions of dollars for coronavirus testing and contact tracing in future pandemic relief legislation.

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