FDA Issues Emergency Approval of New Antigen Test That Is Cheaper, Faster and Simpler
An antigen test made by Quidel Corp. was granted emergency use authorization by the Food and Drug Administration (FDA) on May 8, making it the first antigen test specific to the coronavirus. The test requires a nasal swab of the patient and is tested immediately at the point-of-care. It works by identifying proteins found on or within the coronavirus. FDA says it expects to authorize more antigen tests in the near future. Quidel says its Sofia 2 SARS Antigen FIA test can provide results within 15 minutes. Test cartridges are placed in its Sofia 2 machine or manually developed on a countertop. Quidel is already shipping the test kits to customers, the company says. To date, FDA authorized three types of tests to help detect, diagnose, and track the spread of the novel coronavirus: the new antigen test, polymerase chain reaction (PCR) tests, and antibody screening tests. However, the antigen test is less accurate than the PCR test because it is not as sensitive, says the FDA, noting that negative results do not necessarily rule out the presence of the virus. As a result, FDA says all negative antigen tests should be confirmed with a PCR test. Scott Gottlieb, former FDA commissioner, notes that in general, antigen tests should increase accessibility to testing for consumers because the machines used to process the kits are already in doctor's offices nationwide. He says, "What the CDC needs to do is come out with blanket guidelines that can apply to any doctor's office."
CAP Survey of Laboratories Confirms COVID-19 Testing Challenges, Supply Shortages, and Excess Capacity
A nationwide survey of clinical laboratory directors conducted by the College of American Pathologists (CAP) found that nearly 60 percent of clinical laboratories are providing COVID-19 testing. Of these laboratories, nearly 80 percent said they have the capacity for additional testing. Respondents anticipated their COVID-19 testing volume to increase by roughly 40 percent over the coming two weeks. However, 69 percent of respondents reported difficulty in acquiring test kits for conducting COVID-19 testing, 66 percent found it difficult to acquire nasopharyngeal swabs, and 62 percent said they were experiencing difficulty in obtaining viral transport media/universal transport media. Laboratory directors surveyed also cited increased stress on pathologists and laboratory professionals as a result of longer work hours, resulting in more burnout. All laboratories said they are facing significant financial stresses, irrespective of whether they are providing COVID-19 testing, as well as substantial losses in revenues; some facilities had to furlough employees. Approximately 65 percent of survey respondents were from hospital-based laboratories, of which 43 percent were based in nonacademic hospitals and 22 percent in academic hospitals. CAP President Dr. Patrick Godbey said, "According to the CAP's survey, many laboratories nationwide have excess capacity to test for COVID-19 but are struggling to acquire the necessary testing supplies."
U.S. States Move to Expand Coronavirus Testing Capabilities
Wall Street Journal
As some states ease restrictions on travel and businesses, state leaders are also taking steps to make COVID-19 testing more widely available. New York Gov. Andrew Cuomo said 22 additional locations statewide would provide testing for thousands of residents. The sites will be set up in churches in low-income areas and focus on African-American and Hispanic communities. Cuomo encouraged residents to obtain tests, even if they have no symptoms. He also said he would proceed with caution when determining whether to reopen the state, while noting a decline in hospitalization rates. Delaware Gov. John Carney said his state would launch an initiative to quadruple its testing ability, while Connecticut announced it would now allow pharmacists to order COVID-19 tests in addition to physicians, according to Gov. Ned Lamont. Some leading public health physicians say the nation needs to double the amount of testing it is doing and conduct at least 4 million tests per week to monitor COVID-19. The Food and Drug Administration moved to expand testing by granting emergency use authorization to the first antigen test for COVID-19, which produces more rapid results. Maine Gov. Janet Mills said some businesses in 12 counties with low case counts and no evidence of community transmission would be allowed to open. Rhode Island also lifted emergency measures, and California allowed such retailers as clothing stores, bookstores, florists, and sporting goods stores to offer curbside pickup.