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8A — THE OBSERVER TuESday, auguST 18, 2020 NATION FDA authorizes saliva-based COVID-19 test developed at Yale Editor’s Note: This article is republished with permission from Yale University. By Michael Greenwood Yale University A saliva-based lab- oratory diagnostic test developed by researchers at the Yale School of Public Health to deter- mine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. Food and Drug Adminis- tration (FDA). The method, called SalivaDirect, is being fur- ther validated as a test for asymptomatic individ- uals through a program that tests players and staff from the National Basket- ball Association (NBA). SalivaDirect is simpler, less expensive, and less invasive than the traditional method for such testing, known as nasopharyngeal (NP) swab- bing. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing. With the FDA’s emer- gency use authoriza- tion, the testing method is immediately available to other diagnostic labo- ratories that want to start using the new test, which can be scaled up quickly for use across the nation — and, perhaps, beyond — in the coming weeks, the researchers said. A key component of SalivaDi- rect, they note, is that the method has been vali- dated with reagents and instruments from multiple vendors. This flexibility enables continued testing if some vendors encounter supply chain issues, as times and costs, to make experienced early in the testing widely accessible. pandemic. “Wide-spread testing “The preprint on the development and validation is critical for our con- of SalivaDirect was recently trol efforts. We simpli- fied the test so that it only posted on medRxiv. costs a couple of dollars for Development of reagents, and we expect that SalivaDirect as a means labs will only charge about of rapidly expanding $10 per sample. If cheap SARS-CoV-2 testing was alternatives like SalivaDi- spearheaded this spring by Nathan Grubaugh and Anne rect can be implemented across the country, we may Wyllie, assistant professor finally get a handle on this and associate research sci- entist, respectively, at Yale pandemic, even before a School of Public Health. vaccine,” said Grubaugh. Date Modifi ed: August PM of the team’s goals After finding saliva to be 13, 2020 2:19 One a promising sample type was to eliminate the expen- for SARS-CoV-2 detection, sive saliva collection tubes that other companies use to they wanted to improve the preserve the virus for detec- method further. “With saliva being quick tion. In a separate study led and easy to collect, we real- by Wyllie and the team at ized it could be a game- the Yale School of Public changer in COVID-19 diag- Health, and recently pub- lished on medRxiv, they nostics,” said Wyllie. With testing urgently needed, the found that SARS-CoV-2 is stable in saliva for pro- Yale team was determined longed periods at warm to decrease both testing temperatures, and that pre- servatives or specialized tubes are not necessary for collection of saliva. The Jackson Labora- tory for Genomic Medi- cine in Farmington, Con- necticut, will partner with Yale to explore how to implement the test for a broader audience. The lab- oratory already analyzes patient samples for an RNA signature unique to that of SARS-CoV-2, the virus that causes COVID-19. “We must continue to invent and implement new ways to conduct SARS-CoV-2 testing faster, more economically and with greater accessibility, while maintaining acceptable test accuracy,” said Charles Lee, the lab’s director. “This is an important next step toward this goal.” Grubaugh and Wyllie said that they are not seeking to commercialize the method. Rather, they want the simplified testing method to help those most in need. Testing for SARS-CoV-2 has been a major stumbling block in the fight against the pan- demic, with long delays and shortages of testing. Some experts have said that up to 4 million tests are needed per day; SalivaDirect pro- vides one pathway toward that goal, the researchers said. “Using SalivaDirect, our lab can double our testing capacity,” said Professor Chen Liu, chair of Yale Pathology, who oversaw the clinical validation of the study. “Dr. Liu and Yale Pathology Laboratory were instrumental in our appli- cation. We look forward to continuing to partner with them,” said Grubaugh. Switch and get AP Photo/Don Thompson, File In this July 12, 2018, file photo, Jane Carson-Sandler, of South Carolina, who was raped by the Golden State Kill- er in 1976, holds a sign with a message to her attacker in Sacramento, California. She is among survivors who this week plan to confront Joseph James DeAngelo during four days of court hearings before the 74-year-old is sen- tenced to life in prison. Victims tell of trauma in rape, murder case By Don Thompson Associated Press SACRAMENTO, Calif. — Jane Carson-San- dler said she has served an effective life sentence in the more than four decades since she was one of the first rape victims of a one-time police officer who eventually became known as the Golden State Killer. Now it’s Joseph James DeAngelo’s turn. Carson-Sandler will be among nearly three dozen victims or survivors who plan to confront DeAn- gelo this week during an extraordinary four days of court hearings before the 74-year-old is sentenced to life in prison. Some plan to tell of their pain, others of their healing. It’s the culmination of a plea deal that will spare him the death penalty for 13 murders and numerous sadistic rapes and bur- glaries that terrorized Cal- ifornia for more than a decade. The perpetrator behind the reign of terror mystified investigators until they used a new form of DNA tracking to arrest him in 2018. “Our wounds heal and our scars remain,” Car- son-Sandler said. Certain things always trigger flashbacks to that night in 1976 when DeAn- gelo confronted her with a butcher knife as she snuggled in bed with her 3-year-old son after her husband left for work at a nearby military base. She can’t go skiing, for fear she’ll see someone in a ski mask like the one DeAngelo wore. The sound of a helicopter is another trigger, because “after the attack the heli- copters would fly over every night with spotlights on the ground, looking for DeAngelo.” DeAngelo pleaded guilty in June to 13 counts of murder and admitted to dozens of rapes that were too old to prosecute. His attorneys did not respond to a request for comment. All told, he admitted to 161 crimes involving 48 people. Testimony from DeAngelo’s Sacra- mento County rape vic- tims alone will consume a full day Tuesday. Other rape victims will speak Wednesday, and family members of those mur- dered will speak Thursday before Sacramento County Superior Court Judge Michael Bowman formally sentences DeAngelo on Friday. Kris Pedretti was 15 when DeAngelo attacked her just before Christmas in 1976. “This kid who liked to go shopping and do cart- wheels on the lawn, that girl was gone,” she said. She lost her friends, her once profound faith in God, switched schools three times, had two failed marriages, and “did a lot of self-medicating, a lot of poor coping mechanisms.” It wasn’t until DeAnge- lo’s arrest that she sought therapy and changed her life again. She’s now happily mar- ried, is described by other survivors as the “den mother” who helps orga- nize pot luck dinners after each of DeAngelo’s court appearances, and this year she started a Facebook group for sexual assault survivors. 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