FDA approves first batch testing for COVID-19 to increase testing capacity

Coronavirus

RALEIGH, N.C. (WNCN) – The FDA approved Quest Diagnostics to use sample pooling in its COVID-19 testing.

Quest Diagnostics, which has laboratories in the Triangle region, was the first to get clearance to do this.

Rather than running one patient’s sample at a time, four samples, called a pool or batch, can be tested at once.

The Food and Drug Administration said if a pool triggers a positive result for COVID-19, then each sample is tested individually to see which patient’s sample is testing positive for the virus. If the pool tests negative, all patients are considered negative for the virus.

The FDA said testing multiple samples allows for more tests to be run in a shorter window of time. They said it should allow for tests results to be returned more quickly.

It also requires less testing supplies addressing concerns from medical professionals about testing supply shortages. Those issues have slowed down testing and limited the number of tests that can be done.

When contacted by CBS17.com, Quest Diagnostics said: “The technique is an efficient way to evaluate patients in regions or populations with low rates of disease. Pooling is used routinely in blood banking to screen donated blood for a variety of viruses, among other applications.”

Source: Quest Diagnostics

The company said the clearance would help optimize testing capacity.

Batch testing would take Quest Diagnostics’ daily capacity from 125,000 daily COVID-19 tests to 150,000 daily COVID-19 tests by the end of the month.

With repeated expressions of concern for slow turnaround times for COVID-19 tests, CBS17.com asked Quest Diagnostics what kind of impact the FDA’s clearance will have on tests results. The company said it was still evaluating that time frame.

Right now, the company reports turning around results in one day for priority patients. Other priority patients can expect results in seven or more day.

Pooling will help expand testing capacity but it is not a magic bullet, and testing times will continue to be strained as long as soaring COVID-19 test demand outpaces capacity.

QUEST DIAGNOSTICS

While the emergency approval from the FDA is good news, it only increases testing by 50,000 daily tests nationally.

Quest Diagnostics said: “Pooling will help expand testing capacity but it is not a magic bullet, and testing times will continue to be strained as long as soaring COVID-19 test demand outpaces capacity.”

The company reported more than 7 million tests conducted in July.

In April, they ran a fraction of that at 1 million tests.

The FDA there were concerns pooling samples together may make it challenging to detect positive tests. However, they said in a press release, “Quest’s validation data demonstrates that its test correctly identified all of the pooled samples that contained a positive sample”.

It’s unknown when the pooling technique start to be used in North Carolina. The company announced it would first be used in laboratories in Chantilly, Virginia, and Marlborough, Massachusetts, by the end of next week. More locations are expected to be added later.

Self-swabs and antibody tests are not cleared for pooling.

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