YALE DAILY NEWS · FRIDAY, NOVEMBER 12, 2021 · yaledailynews.com
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FDA authorizes SalivaDirect for pooled COVID-19 testing BY SOPHIE WANG CONTRIBUTING REPORTER SalivaDirect, a Yale-created protocol that allows for greater efficiency in COVID-19 testing, has received FDA emergency use authorization to be used for pooled COVID-19 virus testing of up to five individual samples at a time. SalivaDirect is a PCR test which uses self-collected saliva to detect COVID-19 cases. It was developed by a team of researchers at the Yale School of Public Health. The team began its research in March 2020. In August 2020, SalivaDirect received its initial EUA from the Food and Drug Administration. “Testing is still critically important for getting us out of the pandemic,” Nathan Grubaugh, associate professor of epidemiology at the School of Public Health, wrote in an email. “The goal of SalivaDirect is to be as flexible as possible to provide testing options for a multitude of uses. Pooling up to five samples prior to testing will be a great option for screening programs where the population has an expected low positivity rate, such as for routine school or university testing. This helps to preserve resources and drive down the costs.” Anne Wyllie, research scientist at the School of Public Health, leads the SalivaDirect team. At the onset of the COVID-19 pandemic, she noticed that there were a lot of challenges involved with nasopharyngeal swabs, which were the “gold standard” of COVID-19 testing. Wyllie explained that the supply chains for swabs were collapsing, since the swabs were coming from Italy — a country that experienced a very early outbreak. In addition, mostly those who could afford a COVID-19 test were able to get tested. Moreover, Wyllie noted that getting tested with the swabs was “not exactly pleasant” since the procedure required those who administered the test to “jab” the swab into the nostril of the person being tested. Having worked with saliva as a sample type for the past 10 years in her research, Wyllie wondered if a testing method using saliva could be developed, since “saliva is much easier to collect.” Although she was “definitely one of the most junior on the team” at the time, after explaining her idea to others, she received support from researchers at Yale.
“First of all, we set out to develop SalivaDirect to increase access,” Wyllie said. “Early on in the pandemic we were really frustrated that … other than symptomatic people, … people who could afford to get tested were the only other ones who could get tested … We were determined to develop a test that could be more affordable … We also wanted to make a kit that could be used by others. We wanted to make [it] a very open source protocol that other labs could readily pick up, start using and decrease the time it would take them to implement an EUA test in their community.” Annie Watkins SPH ’21, former graduate research assistant at the School of Public Health, emphasized that a main focus of the research team was to ensure that “testing could be more readily available” by “cut[ting] out some of the barriers.” Watkins observed that the team managed to “work quite hard” to validate the SalivaDirect protocol across multiple different testing platforms and reagents. She noted that these validations would prevent labs from needing to rely on one machine or supply kit, allowing them to take advantage of the supplies they have or can easily acquire. As a result, the labs would be able to “keep costs down but quality up.” Pooling samples together creates significant advantages in terms of streamlining COVID-19 tests and their costs. “One of the unique aspects of SalivaDirect is that it is a simplified and flexible platform that is being further developed by the SalivaDirect team,” Chantal Vogels, associate research scientist at the School of Public Health, wrote in an email to the News. “[The] pooling of samples … will help to further reduce cost and increase testing capacity.” According to Wyllie, being able to pool up to five samples is a reasonable amount, since pooling together at most five individual samples does not burden labs who can conduct only manual tests “all by hand.” She explained that if the pooled sample produces a positive result, then the lab needs to go back and retest all the individual samples. Despite the FDA approval for pooled testing, Wyllie does not anticipate Yale switching its current method of conducting COVID-19 tests through nasal swabs to
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SalivaDirect. She recalled that when Yale decided to bring students back to campus in fall 2020, the University had considered using SalivaDirect as the method of COVID-19 testing. However, they needed to have an EUA test available for the students, and back then, SalivaDirect had not received its first EUA from the FDA yet. To avoid the risk of setting up an entire testing program that might not have an EUA, Yale decided to provide their students with anterior nasal swab tests. “I can very much understand how much work goes into setting up testing programs,” said Wyllie. “It’s also the costs that are involved with completely changing the system over again as well.” Wyllie emphasized the importance for labs and research groups to continue their work even when the number of COVID-19 cases start decreasing. According to Wyllie, when case rates start decreasing and fewer COVID-19 tests are being administered, surges around
the country occur “again and again.” This trend was demonstrated around spring time in 2021, when labs stopped conducting surveillance testing because of a decline in cases, and another COVID-19 surge occurred shortly after. It is important that labs continue to stay in operation in order to account for any possible future case spikes, she said. Wyllie and her research team plan to continue SalivaDirect research. Wyllie noted that other labs sometimes approach her team and ask them to experiment with and include a specific instrument in the EUA, which will then allow that lab to use SalivaDirect with materials they have access to. According to the Center for Disease Control and Prevention COVID-19 data tracker, as of Nov. 8, there are 598 COVID-19 cases in New Haven. Contact SOPHIE WANG at sophie.wang@yale.edu .
Yale New Haven Health System faces nurse shortage BY DANTE MOTLEY CONTRIBUTING REPORTER As the Yale New Haven Health System emerges from the brunt of its battle with coronavirus, it faces another challenge — an ongoing shortage of nurses. The health system has a “very, very large volume” of open positions, Melissa Turner, senior vice president for human resources at YNHH, told the New Haven Register. Turner attributed the challenges to the increasingly taxing job of being a nurse, as well as to a nationwide labor shortage. Nurses who served during the COVID-19 pandemic encountered numerous patients on ventilators and risked their personal safety to treat patients infected with the highly contagious virus. Now, as local case rates lower, the health system has seen a greater influx of patients as a result of elective surgeries that were rescheduled earlier in the pandemic. These patients are often in a worse condition than usual after putting off procedures for multiple months or years, Turner explained. Two nurses spoke to the News on the condition of anonymity due to fear of loss of livelihood. They were told by hospital Human Resources not to speak to the media about the issue, according to the nurses. The News could not confirm the veracity of this statement. Media Relations Coordinator for YNHH Mark D’Antonio attempted to connect the News with hospital leadership, but ultimately did not answer multiple requests for comment. He said that no frontline nurses or other hospital staff would be available for the story. “Working during COVID made them realize that it might not be worth it to be near all that sickness for those long hours for the amount of pay,” one nurse said. “They are just getting burnt out. It is not the hospital or Yale’s fault.” According to Beth Beckman, chief nursing executive for YNHH, burnout is a major issue among nurses. She cited a survey by the American Organization for Nursing Leadership that showed that 75 percent of nurse leaders saw the emotional health and wellbeing of staff as a major issue. With the increased workload wrought by the pandemic as well as fewer nurses, Beckman said that YNHH had to ask many nurses to work more hours. She said that nurses have “raised their hand” to make sure patients receive care and added that the hospital has adapted its operations as the pandemic has progressed.
“Our mantra and our real commitment is to take care of our people,” Beckman said. “Our frontline. And I think the most important thing we’re going to do in this space is to listen to their ideas. They commonly have the solutions and to institute them in a way that’s helpful to them. So we absolutely are committed to making sure the frontline helps us modify whatever it is we need in our work environment.” According to Beckman, the nursing shortage is nationwide. She said that hospitals are facing the same operational challenges nationally, and probably globally. Still, Beckman added that the hospital system had a large number of tenured staff who stayed throughout the pandemic and have weathered the increased visits beyond it.
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“We’ve had many, many nurses choose to stay, and we are so grateful for their loyalty,” Beckman said. The hospital system did terminate the employment of 11 nurses who would not receive a COVID-19 vaccine, out of the more than 7,200 nurses the hospital employs. But Beckman noted that nine of them were casual labor, not holding full time or part time positions. She said that if they got the vaccine they would be re-employed. She also emphasized the importance of all nursing staff and said that “even losing one is something that we’d like to avoid.” According to Patricia Carson, the director of perioperative services for the Nuvance Health Network spanning hospitals in Western Connecticut, the nursing shortage is “not a new issue.” There has been a larger issue of nursing schools lacking teachers to pass on the skills required for such a technically demanding job. This forces schools to limit the number of candidates they are able to accept.
“Operations have not been directly affected,” Carson wrote in an email to the News. “We have managed through the efforts of the employees and administration to quell the effects of the national nursing shortage. Patient care is still the utmost priority and we are delivering.” Carson noted that the shortage prompted her to work with her colleagues from inpatient units to ensure the continuation of effective nursing care. To increase nursing retention and recruitment, her team has implemented strategies ranging from nurse residency programs for new nursing school graduates to Zoom recruitment fairs. Carson also said that the COVID-19 pandemic’s impact on nurses may have caused some to retire early. But while some nurses were turned away due to higher workloads during the pandemic, others opted to take on better-compensated and more flexible paths in the industry. One nurse at YNHH said that nursing was “not about the money, but has become about the money.” During the pandemic, some former frontline nurses became travel nurses to pay off mortgages in short periods of time, as travel nurses are known to earn higher pay. “I have student debt for both me and my daughter and I could use that money,” one nurse said. “It is not sustainable though. They will have to come back at some point,” another nurse added. To cope with the shortage, YNHH has embraced creative recruitment options. YNHH also worked with nursing schools in the state and the Connecticut Hospital Association to allow senior students to join the workforce. Yale New Haven Health also distributed five percent bonuses in May 2020. But due to pandemic-driven financial losses, the hospital system’s annual performance incentives were one percent instead of their usual two percent. Managers showed their appreciation for hospital staff in other ways, including a “week of gratitude,” in which they spent two hours each day walking rounds with staff members, Turner told the Register. Yale New Haven Health is the second largest employer in Connecticut. Contact DANTE MOTLEY at dante.motley@yale.edu .
