FDA issues first emergency use authorization for COVID-19 pool testing

LONGER IN THE CASE OF A WOMAN WE SPOKE WITH TODAY. CARROLL COUNTY HEALTH AUTHORITIES HAVE BEEN RUNNING A COMMUNITY CORONAVIRUS TEST SITE. IT’S WHERE MARCIA HOFFMAN WENT JULY 2 TO BE TESTED, SO SHE COULD VISIT HER GRANDCHILDREN. >> I THOUGHT MAYBE I NEEDED GET TESTED BECAUSE I ALSO HAVE NOT BEEN ABLE TO VISIT WITH MY THREE-YEAR-OLD AND INFANT GRANDDAUGHTERS, WHICH IS REALLY VERY SAD, AND MAKING ME VERY SAD. SO THAT’S WHY I GOT TESTED. JAYNE: THE BROCHURE MARCIA GOT FROM THE LAB PROCESSING THE TEST, QUEST DIAGNOSTICS, SAID SHE SHOULD EXPECT RESULTS ABOUT DAYS. FIVE THAT DID NOT HAPPEN. MARCIA’S RESULT DID NOT COME BACK UNTIL THIS AFTERNOON, 13 DAYS LATER. >> NOT GETTING A RESULT PUTS PERSON IN A VERY VULNERABLE PLACE BECAUSE, YES, YOU HAVE TO, ON THE HANDOUT IT TELLS YOU TO QUARANTINE YOURSELF UNTIL YOU GET YOUR RESULTS. JAYNE: QUEST DIAGNOSTICS GAVE NOTICE THIS WEEK RESULTS COULD TAKE AT LEAST SEVEN DAYS FOR PEOPLE NOT IN A HOSPITAL OR WORKING IN HEALTHCARE WITH SYMPTOMS. DESPITE OUR RAPID SCALING UP OF CAPACITY, A STATEMENT SAID, SOARING DEMAND FOR COVID-19 TESTS ACROSS THE UNITED STATES IS SLOWING THE TIME IN WHICH WE CAN PROVIDE TEST RESULTS. THE STATEMENT WENT ON, WE ATTRIBUTE THIS DEMAND PRIMARILY TO THE RAPID, CONTINUING SPREA OF COVID-19 INFECTIONS ACROSS THE NATION, BUT PARTICULARLY IN THE SOUTH, SOUTHWEST, AND WEST REGIONS OF THE COUNTRY QUEST IS ONE OF THE COUNTRY’S LARGEST LABS ITS STATEMENT SAID IT’S TRYING TO INCREASE ITS PROCESSING CAPACITY BY 25,000 TESTS PER DAY BY THE END OF THE MONTH. DELAYS IN RESULTS MEAN THE DAILY REPORTING OF CASES BY THE STATE HEALTH DEPARTMENT MAY LAG RE TRENDS IN THE SPREAD OF THE VIRUS. AND PUBLIC HEALTH EXPERTS WARN WITHOUT MORE TIMELY RESULTS, CONTACT TRACING IS LESS EFFECTIV ONE QUESTION SHE HAD IN ALL THE TIME SHE WAS WAITING, SHOULD SHE GET TESTED AGAIN? THAT IS A QUESTION WE ASKED TO THE CDC, WHO REFERRED US BACK TO THE STATE HEALTH DEPARTMENT.

Video above: Delays in coronavirus test results caused by high demand for testing in MarylandThe U.S. Food and Drug Administration on Saturday announced it has issued an emergency use authorization that allows the laboratory Quest Diagnostics to pool samples from up to four individuals to test for COVID-19.This is the first COVID-19 diagnostic test in the United States to be authorized for use with pooled samples, the agency said in a statement."This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies," FDA Commissioner Dr. Stephen Hahn said in the statement. "Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population."Sample pooling allows multiple people to be tested at once. The samples are collected and then tested in a pool or "batch" using just one test. If the pool tests positive, this means one or more of the people tested in that pool may be infected with the virus. Each of the samples would then have to be tested again individually.The FDA last month published guidance for developers that want to make and use tests for pooled samples.In late June, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said the White House Coronavirus Task Force was "seriously considering" pool testing as a new strategy to improve testing as the U.S. experienced a surge in COVID-19 cases.Fauci also touted the strategy during a Senate committee hearing, saying pool testing for coronavirus could be a useful tool as schools look to reopen in the fall.Pool testing helps "get a feel for the penetrance of infection in a community, rather than testing multiple each individual person, which takes resources and time," Fauci said.Dr. Deborah Birx, the White House coronavirus response coordinator, also spoke about how pool testing can improve the country's testing capacity."If you look around the globe, the way people are doing a million tests or 10 million tests is they're doing pooling," Birx said during an online conference of the American Society for Microbiology late 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."In its statement, the FDA said that while there is a "concern that combining samples may make it more difficult to detect positives, since pooling in the laboratory dilutes any viral material present in the samples," Quest's validation data correctly identified all of the pooled samples that contained a positive sample.Quest said in a statement it expects to deploy the testing technique at two of its laboratories by the end of next week, and additional laboratories will follow.

Video above: Delays in coronavirus test results caused by high demand for testing in Maryland

The U.S. Food and Drug Administration on Saturday announced it has issued an emergency use authorization that allows the laboratory Quest Diagnostics to pool samples from up to four individuals to test for COVID-19.

This is the first COVID-19 diagnostic test in the United States to be authorized for use with pooled samples, the agency said in a statement.

"This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies," FDA Commissioner Dr. Stephen Hahn said in the statement. "Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population."

Sample pooling allows multiple people to be tested at once. The samples are collected and then tested in a pool or "batch" using just one test. If the pool tests positive, this means one or more of the people tested in that pool may be infected with the virus. Each of the samples would then have to be tested again individually.

The FDA last month for developers that want to make and use tests for pooled samples.

In late June, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said the White House Coronavirus Task Force was "seriously considering" pool testing as a new strategy to improve testing as the U.S. experienced a surge in COVID-19 cases.

Fauci also touted the strategy during a Senate committee hearing, saying pool testing for coronavirus could be a useful tool as schools look to reopen in the fall.

Pool testing helps "get a feel for the penetrance of infection in a community, rather than testing multiple each individual person, which takes resources and time," Fauci said.

Dr. Deborah Birx, the White House coronavirus response coordinator, also spoke about how pool testing can improve the country's testing capacity.

"If you look around the globe, the way people are doing a million tests or 10 million tests is they're doing pooling," Birx said during an online conference of the American Society for Microbiology late 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."

In its statement, the FDA said that while there is a "concern that combining samples may make it more difficult to detect positives, since pooling in the laboratory dilutes any viral material present in the samples," Quest's validation data correctly identified all of the pooled samples that contained a positive sample.

Quest said in a statement it expects to deploy the testing technique at two of its laboratories by the end of next week, and additional laboratories will follow.

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