Why is Yale's new crown saliva test called a "breakthrough" by the FDA director?

The steps to remove nucleic acid extraction We already know that large-scale nucleic acid testing and tracking of people who have come into contact with infected patients is one of the effective means of controlling the expansion of the new crown outbreak.
most common detection method is to use nasopharyngeal swabs to obtain samples for RT-PCR-based nucleic acid detection.
, however, the process of obtaining a nasopharyngeal swab sample is not a very comfortable process for people, and most of the current nucleic acid testing requires steps to purify the nucleic acid from the sample.
this step not only increases the time and cost of processing samples, but may also affect the speed of new crown detection due to a shortage of nucleic acid purification kits.
at Yale University's School of Public Health are trying to develop a "simple version" of the new coronavirus test based on saliva samples.
first, they found that the new coronavirus RNA in saliva was as stable at room temperature and at 30 degrees C as it was at 4 degrees C without adding preservatives.
means that saliva samples do not need special sample bottles to collect, and any sterile sample bottle can be used to collect saliva samples, facilitating the collection of saliva samples.
, the researchers further explore ways to simplify the nucleic acid detection process.
After simplifying the sample processing process to add protease K, a protease commonly used in DNA extraction, to the degradation protein in the sample, the treated sample was used directly for the RT-PCR testing process, removing the steps to purify the nucleic acid from the sample.
researchers found that the results of the "simple version" testing process for removing purified nucleic acid extraction steps based on saliva samples were 94% more relevant than conventional RT-PCR tests based on nasopharyngeal swabs, using purified nucleic acid extraction steps.
SalivaDirect nucleic acid testing process and test performance (Photo source: Resources) Expanded the scope of testing to allow this test to be used in more testing laboratories, and the researchers also tested it using protease K and RT-PCR kits produced by different manufacturers.
they found that a variety of common protease K and RT-PCR kits could be used in this "simple version" of the new crown detection process, detecting sensitivity of 6-12 copies/microliers of new coronavirus.
means that many testing labs don't need to buy special reagents, which can be built using reagents already at hand by following the testing process released by Yale University.
Researchers at Yale University who have validated reagents and instruments for the SalivaDirect process (Photo source: Resources) also say they will provide an "open source" testing process for all interested laboratories to help them improve the efficiency of new coronavirus detection.
at the same time, they are further validating the ability of this testing process to identify asymptomatic patients.
researchers say the study is an important step in that direction, as new coronavirus detection requires constant innovation to make them faster, more convenient and more accessible while maintaining accuracy.
: s1. Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which a New Method of Saliva Process Sampleing. Retrieved August 16, 2020, from s quick and affordable saliva-based COVID-19 test developed by Yale scientists receives FDA Emergency Use Authorization. Retrieved August 16, 2020, from s.3. Vogels et al., (2020). SalivaDirect: Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance. medRxiv, original title: Yale University's "simple version" of the new crown saliva test was authorized for emergency use, why is it called a "breakthrough" by the FDA director?