Facing the world’s largest coronavirus outbreak and long waiting times for test results, the Food and Drug Administration on Saturday issued first emergency use authorization for covid-19 group tests, A form of test that allows up to four samples to be analyzed at the same time using the same test.
Real-time PCR group test belongs to Quest Diagnostics, the largest private medical testing company in the United States, which one recently declared that the average waiting time for people who are not considered priority patients is seven or more days. The company does not expect to reduce those timeouts as long as covid-19 cases continue to rise dramatically in the U.S.
In its Press release announcing the emergency use authorization, The FDA said that pooling samples is an important public health tool because it allows more people to be tested quickly using fewer testing resources. Instead of using an individual test on each sample, group tests analyze several people at once using only one test.
In this case, up to four samples are analyzed in one group. According to the FDA, if the group is positive, it means that one or more of the people tested in the batch may be infected. If this situation occurs, all samples in the group are re-analyzed individually. The FDA noted that this technique is expected to save test supplies, which is another problem laboratories face.
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“Because the samples are pooled, fewer tests are expected to be performed overall, which means fewer test supplies are used and more tests can be performed at the same time, allowing patients to receive their results more quickly. in most cases, “the FDA said.
Quest Diagnostics, for example, has said that global supply constraints remain a problem, a factor that limits how quickly tests can scale up. capacity. Aalthough the company maintains that your test platform and reagent providers continue to respond to your need to add capacity, “They are limited amid growing demand in the United States and around the world.”
Quest Diagnostics said last week that currently has the ability to run 125,000 molecular diagnostic tests per day, roughly double the capacity it had eight weeks ago. It expects to have the ability to run 150,000 tests a day by the end of July.
However, this new testing technique is not the final solution. to America’s testing problems and is not suitable in all situations. The FDA says this technique is more efficient in areas with low prevalence, or areas where low numbers of people are actively on covid-19.
The agency also addressed concerns that analyzing multiple samples would make it difficult to detect positive results, “Since clustering in the laboratory dilutes any viral material present in the samples.” However, he said that validation data Quest Diagnostics provided the agency receiving your emergency use authorization and demonstrated that its corrected test identified all pooled samples that contained a positive sample.
Quest Diagnostics declared in a Press release than in the clinical data submitted to the FDA, none of the 3,091 specimens with a prevalence rate of between 1 and 10%, if they had been grouped together, would have been incorrectly determined as negative. The company stated that the pool is frequently used in blood storage to detect donated blood for a variety of viruses.
Jay Wohlgemuth, senior vice president and chief medical officer of Quest Diagnostics, applauded the FDA for allowing him to use his covid-19 group test. However, he also cautioned that this was not the way to solve the United States’ testing problem.
“The pool will help expand testing capacity, but it is not a magic bullet, and testing times will continue to be tight as demand for covid-19 testing increases capacity,” Wohlgemuth said in a statement. “Each of us can practice behaviors that will reduce covid-19 infections in our communities, so that our national health system can better respond to this crisis.”
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