The U.S. FDA announced July 18 that it has granted an emergency use authorization to Quest Diagnostics Inc. for the company’s real-time, reverse transcriptase polymerase chain reaction test for the SARS-CoV-2 virus in a development that FDA commissioner Stephen Hahn described as “an important step forward.” The Quest test had previously been authorized for individual nasal swab specimens collected by the individual at home, but the new EUA allows the test to be used for up to four swabs collected from any one of four sites, including the oropharynx and the nasal nares.
The FDA said this approach to pooling will assist in economizing resources, such as swabs and other supplies, and would reduce wait times for patients in many instances. Pooling will be deployed as a surveillance instrument in areas with low known prevalence of COVID-19, and Hahn said sample pooling “becomes especially important as infect rates decline and we begin testing larger portions of the population.” This pooling EUA carries a requirement that the sample be collected under supervision.
Secaucus, N.J.-based Quest said in its July 18 statement that the data presented to the FDA for this updated EUA demonstrated that none of the nearly 3,100 total specimens would have been incorrectly determined to be negative, if pooled, a determination based on a population with a prevalence of rate of 10% or less. The company will deploy the technique at its plants in Chantilly, Va., and Marlborough, Mass., “by the end of next week, with additional laboratories to follow,” the company said. In a separate July 18 statement, Quest said it has performed roughly 7.4 million diagnostics tests for COVID-19 to date, and another 2.5 million serology tests. Daily capacity is 125,000 molecular/diagnostic tests and 200,000 antibody tests via serology.