New detection method for new coronavirus approved by FDA

A method of detecting novel coronavirus by saliva samples was obtained by the US Food and Drug Administration for emergency use 15 days ago. It has the characteristics of cheap, simple, fast and accurate, which is called “pioneering”.

this new coronavirus detection method, named saliva direct, was developed by Yale University researchers. It reduces the dependence on detection products and does not need to extract nucleic acid.

it does not need swabs for nasal and throat sampling. The examinee only needs to leave saliva sample in “any sterile container”. It does not use nucleic acid preservation solution or special test tube. The researchers said they found that the new coronavirus was “stable for a long time in a warm environment.”. In addition, the new method can use a variety of existing detection reagents and devices on the market.

according to the FDA, the new detection method can reduce the demand for scarce testing resources and help improve the detection capability. FDA director Stephen Hahn said it was a “groundbreaking” test “in terms of efficiency and preventing a critical shortage of testing supplies.

this is the fifth new coronavirus saliva test method authorized by the FDA for emergency use, and is funded by the U.S. men’s professional basketball league. 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.

compared with pharyngeal swab and nasal swab test, subjects only need to leave saliva samples in the container, which reduces the risk of medical staff infected with virus, and there is no discomfort when swabs are inserted into nasal cavity and throat for sampling.

the US Yahoo News website reported that other saliva testing methods approved by the drug administration cost high, with market prices ranging from $75 to $150 each time, and the results can only be obtained within 48 hours.

Yale researchers say their goal is to develop fast and inexpensive assays that cost between $1.29 and $4.37. “We’ve simplified the test, so it costs only a few dollars on the reagent,” said Natan Gruber, one of the project’s leaders. “We expect the testing laboratory to charge only about $10 per sample.”

the researchers do not intend to profit from the new detection method, but will provide it to interested testing laboratories according to the open source agreement to help improve the detection ability. “Large scale testing is essential to control the epidemic,” Gruber said Pets