The U.S. Food and Drug Administration announced on Saturday that it has approved the Yale University saliva direct emergency use authorization for the detection of new coronavirus, which is more rapid, accurate and cheaper. The NBA is also one of the organizations that funded the study and helped Yale validate the test method.
it is reported that this is the fifth saliva test method approved by FDA. However, the saliva direct assay developed by Yale University is considered to be a cheap, simple and low invasive test method. It does not require nucleic acid extraction, swab or collection equipment, and can use several ready-made reagents.
at present, saliva tests already available on the market, such as the Rutgers University method, cost as much as $150 a time, and the results are produced within 24-48 hours. According to Annie Willie, an assistant professor at Yale School of public health, Yale’s saliva direct estimates that the cost of each sample is only about $10. The results can be obtained within three hours, and up to 92 samples can be tested at a time.
Yale’s test is cheap and fast because it does not require additional steps to extract the genetic material of the new coronavirus from saliva samples, so the laboratory does not need a special extraction kit.
Yale University researchers say that with the FDA’s emergency use authorization, other diagnostic laboratories can immediately use the test method, and in the next few weeks, the method can be rapidly promoted nationwide.
FDA director Stephen M. Hahn said in a statement: “salivadirect is innovative in efficiency, avoiding the shortage of key testing tools such as reagents.”
it is reported that the NBA donated more than 500000 US dollars to Yale University for the research of the project, which also helped Yale verify the test method.
Yale researchers have used this method to test American basketball players and staff. The comparison with the nasal swab test showed that the new saliva test was “highly sensitive” and the results of the two methods were “highly consistent”, more than 94%, the researchers said.
Yale University does not intend to profit from the new detection method, but will provide it to interested testing laboratories under the open source agreement to help improve the detection ability. “Large scale testing is essential to control the epidemic,” grubaugh said. 08/16/2020