Research

Antibody Testing of Healthcare Workers May Show Spread of COVID-19

Posted on Jun 1, 2020 in California Pacific Medical Center, Innovation, Quality, Research, Safety, Scroll Images

antibody tests

A new study launching at Sutter’s California Pacific Medical Center (CPMC) will use antibody tests to identify front-line doctors who have developed antibodies against the virus. Antibody tests (also called “serology tests” because they use blood samples) are used to determine if someone is producing antibodies to defend against the virus.

“A powerful way to help limit the spread of COVID-19 is to facilitate early and accurate diagnoses of viral infections and appropriate quarantine for those infected,” says Greg Tranah, Ph.D., scientific director of CPMC’s Research Institute, director of Sutter’s Center for Precision Medicine Research, and lead researcher of the new physician serology study at CPMC.

Current methods diagnose COVID-19 are valid, but can have limitations when it comes to tracking disease patterns. Serology tests show some promise in this area, for use in certain circumstances.

“Serology tests may help identify people who have been exposed to the virus even weeks after an initial infection, including people who did not show symptoms. Other studies of COVID-19 ‘seropositivity’ can reveal the extent of viral exposure, as well as the timing of first exposure and increasing rates of exposure,” says Dr. Tranah.

The new serology study aims to enroll intensivists, emergency department doctors, infectious disease specialists, anesthesiologists, hospitalists, surgeons and internal medicine residents at CPMC.

Beginning May 18, blood samples will be collected from study participants every eight weeks through 2020. The samples will be tested for the presence of antibodies produced in response to prior COVID-19 exposure. Study participants will be asked to answer a brief questionnaire to determine if they have experienced symptoms of COVID-19.

“We’re using a two-step serology test that can process multiple samples concurrently with high reliability, sensitivity and specificity,”(1) says Jose Montoya, M.D., an infectious disease specialist working at Sutter’s Palo Alto Medical Foundation who is collaborating with Dr. Tranah on the study.

Serology tests with high sensitivity and specificity are less likely to have false-positive or false-negative results and a more meaningful predictive value.

Results of the blood tests will be stored in a database, and rates of seropositivity will be compared across medical specialties bi-monthly. “Longitudinal serology testing will allow us to track rates of seropositivity among different physician specialty groups and study the duration and intensity of immune response to COVID-19,” says Dr. Tranah.

There is no current evidence that people who have detectable antibodies are immune to re-infection from COVID-19 or what the timeframe of immunity is, if any. Until more evidence is available, antibody tests should not be used to make decisions related to social distancing or the use of personal protective equipment.

“Understanding the surge of infection rate and spread is an important part of preparedness. Epidemiological studies of emerging COVID-19 infections can help determine the burden of disease, develop better estimates of morbidity and mortality, and help complement the results of PCR tests,” says Dr. Tranah.

Learn more about COVID-19 tests by following our Educational Series on this topic.

Reference:

  1. Nirmidas Biotech Rapid Test for COVID-19 IgM/IgG.

Can a Long-acting, Injectable Drug Prevent HIV Infections?

Posted on May 31, 2020 in Alta Bates Summit Medical Center, Community Benefit, Expanding Access, Innovation, People, Quality, Research, Scroll Images

Christopher Hall, M.D., knows well the uncertainty and fear sparked by an infectious disease outbreak, as well as the excitement spurred by new research to develop effective treatment and vaccines.

An infectious disease specialist and researcher at Sutter’s Alta Bates Summit Medical Center (ABSMC) in Oakland, Dr. Hall began working to combat the HIV virus in 1987 in Washington, DC. Subsequent clinical leadership work at prominent HIV/AIDS care centers earned him the “street cred” to be selected for consulting roles for sexually transmitted infection (STI) prevention training programs, and membership among a national coalition of STI experts.

While the world awaits effective, safe treatments and a potential vaccine for COVID-19, HIV research has dramatically flashed forward since the AIDS epidemic of the 1980s. Among the biggest achievements in HIV prevention came in 2012, when the U.S. Food and Drug Administration (FDA) approved a daily pill called Truvada® as a means to prevent HIV virus infection—a strategy known as HIV pre-exposure prophylaxis (PrEP) for people who are HIV-negative.

Dr. Hall hopes his latest research initiative will have a similar significant impact. He leads Sutter’s participation at ABSMC in a clinical trial testing a new long-acting, injectable drug for the prevention of HIV. Earlier this month, preliminary results of an international study of the antiviral cabotegravir as PrEP were released by the HIV Prevention Trials Network (HPTN).(1,2) The results haven’t yet been published in a peer-reviewed journal.

The international, Phase 3 study known as HPTN 083 compares the effectiveness of bimonthly cabotegravir injections with oral Truvada® as PrEP to prevent HIV infection in people aged 18 years and older.

Chris Hall, M.D. and research coordinator Trish Smallwood

“This large-scale study is the first of its kind to show a long-acting form of HIV prevention to be highly effective,” says Dr. Hall. “Without a vaccine, the more options for PrEP that we can prove are effective and safe, and make accessible to people who may benefit, the better. Different options are needed for different patients. Cabotegravir injection may be an excellent tool to include in the PrEP toolkit, especially for people who have difficulty taking a daily oral medication as PrEP.”

HPTN 083—a four-year trial that began in 2016—is led by the National Institute of Allergy and Infectious Diseases (NIAID). The study randomized approximately 4,600 men and transgender women who have sex with men and are at high risk of contracting HIV, to receive either intramuscular injections with cabotegravir every two months, daily Truvada®, or placebo.(3)

Among the 50 people who became infected with HIV during course of the study, 12 were randomized to receive cabotegravir and 38 received daily Truvada®. Results showed that one third as many people became infected on cabotegravir compared with the oral drugs.

Though the study was designed to demonstrate that cabotegravir was at least as effective as conventional Truvada®, early results suggested the superiority of the injectable medication. With the encouraging results, an independent safety committee recommended the study stop early.

Conducting the study through ABSMC’s East Bay Advanced Care (EBAC) presented a unique opportunity to enroll participants from diverse, underserved communities in San Francisco’s East Bay area.(4) A commonly reported criticism of past HIV prevention research has been that the populations studied did not reflect the populations most affected.(5,6)

“We enrolled participants from San Francisco’s East Bay with the goal to study a patient population that closely reflects people at highest risk of HIV infection,” says Dr. Hall. Two-thirds of the participants were younger than 30 years old, 12% were transgender women, and 50% were African American.

“All three demographics are among the most vulnerable and at highest risk for acquiring HIV. And although specific enrollment of Latinos/Hispanics was not originally part of the study design, people from Hispanic communities were actively recruited and enrolled, and the study is stronger with their participation.”

Though results of the HPTN 083 study may be a coup for the international HIV/AIDS community, its added value in Northern California may lie in providing a new asset for EBAC: knowledge from medical research that may benefit people seeking care at the Center.

“At East Bay Advanced Care, we’re proud to offer hands-on support, medical treatments, complementary therapies and educational services for people living with HIV/AIDS,” says Jeff Burack, M.D., an internal medicine physician at Sutter and medical director of EBAC. “Insights from studying this promising new strategy for HIV prevention may greatly expand our ability to deliver care informed by science and guided by an ethos to support health equity.”

It is not yet known when single-agent cabotegravir will be reviewed for approval by the FDA for the prevention of HIV. A Viiv Healthcare press release stated that detailed results from HPTN 083 will be presented at an upcoming scientific meeting and used for regulatory submission to the FDA.

East Bay Advanced Care (EBAC): The largest HIV primary care clinic in the East Bay, EBAC delivers care and provides resources to approximately 1,400 people from diverse communities in the surrounding area.

The Center provides a comprehensive continuum of high-quality, professional treatment and support services to all clients regardless of their socioeconomic status. “Our mission is to provide essential, confidential medical and support services to all people living with HIV. The hope is to maximize quality and length of life, and to enhance personal dignity and self-empowerment in the face of HIV,” says Dr. Burack. Each year, an estimated 1.7 million people are newly diagnosed with HIV.(7) Interested in supporting research at EBAC? Donate to Alta Bates Summit Medical Center.

Targeting the HIV/AIDS virus—decades of research give new hope for “cure”: What does it take to halt a virus that has claimed the lives of approximately 32 million people?(7) HIV drugs cannot cure the disease, but they can help people with the virus stay healthy by preventing the virus from reproducing. The HIV virus completes several different steps to make copies of itself as part of the HIV lifecycle. If unimpeded, HIV integrates its viral DNA with the body’s healthy CD4 cells, essentially turning the CD4 cell into a factory that makes more HIV cells, resulting in an HIV infection. All HIV drugs work by interrupting a step in HIV’s lifecycle; this helps halt HIV replication.

Currently, six classes of HIV drugs target four steps of HIV’s lifecycle. Cabotegravir stops the HIV viral replication process at the crucial point of the virus attempting to integrate its DNA with the DNA of a healthy CD4 cell. “The approval of new classes of HIV drugs — and new drugs in the classes already available — will help provide more treatment options for people living with HIV,” says Dr. Hall.

References:

  1. Cabotegravir is manufactured by ViiV Healthcare.
  2. The HPTN 083 study that is part of the NIH-DAIDS-funded HIV Prevention Trials Network (HPTN). HTPN 083 was jointly funded by the U.S. NIAID, part of the NIH, and ViiV Healthcare, and was conducted by the HPTN. Study product was provided by ViiV Healthcare and Gilead Sciences.
  3. This particular group of study participants was selected because, in trials such as HPTN 083, demonstrating efficacy requires the population studied is at risk of acquiring HIV – otherwise, study endpoints cannot be reached in a reasonable amount of time.
  4. HPTN 083 was also offered to partners of existing patients as well as the clinic’s prevention program clients.
  5. A pandemic of the poor: social disadvantage and the U.S. HIV epidemic. Jennifer A. Pellowski, Seth C. Kalichman, Karen A. Matthews, and Nancy Adler. Am Psychol. 2013 May-Jun; 68(4): 197–209. doi: 10.1037/a0032694.
  6. HIV/AIDS Inequality: Structural Barriers to Prevention, Treatment, and Care in Communities of Color. Why We Need A Holistic Approach to Eliminate Racial Disparities in HIV/AIDS. Russell Robinson and Aisha C. Moodie-Mills. July 27, 2012.
  7. World Health Organization data. https://www.who.int/gho/hiv/en/

SARS-CoV-2/COVID-19 Tests: An Educational Series (Part 2)

Posted on May 26, 2020 in Affiliates, Expanding Access, Innovation, Quality, Research, Safety, Scroll Images, Transformation

antibody tests

Testing is conducted to diagnose, understand and help prevent the spread of SARS-CoV-2/novel coronavirus. We encourage people who test positive for the virus to quarantine and isolate themselves to prevent viral spread to others. This is particularly important with COVID-19, the diseased caused by SARS-CoV-2, because some infected people have no symptoms and may unknowingly infect others.

Follow our Educational Series on testing to stay abreast of the latest updates at Sutter. Part 2 of this series (below) describes antibody tests. In Part 1, we described SARS-CoV-2 testing with PCR.

Antibody/Serology Blood Tests for SARS-CoV-2

Overview:
Standard PCR-based tests can identify if someone is currently infected with the SARS-CoV-2 virus. Antibody tests (also called “serology tests” because they are conducted on blood samples) are used to determine if someone is producing antibodies to defend against the virus.

Antibody tests may help identify people who have been exposed to the virus even weeks after an initial infection, including people who did not show symptoms.

When infected by a virus like SARS-CoV-2, the body initially produces antibodies known as IgM (immunoglobulin-M), in efforts to neutralize or fight the virus, followed by the production of the IgG antibody, which more specifically targets the virus. As the body’s immune response accelerates, IgM levels decrease, while IgG persists for a longer period.

Antibody tests assess levels of antibodies produced in response to SARS-CoV-2 infection. The tests can help complement information from detection tests that use PCR.

In March 2020, the U.S. Food and Drug Administration (FDA) issued guidelines allowing manufacturers of antibody tests to market their products without prior FDA review, under certain conditions.

The FDA also authorized several antibody tests under an Emergency Use Authorization (EUA), which means the FDA has reviewed and authorized use of the tests, but has not performed the same type of robust review typically done for the FDA-approved tests used in clinical laboratories.

Antibody tests may help provide clues about who has developed antibodies, how long antibodies last, and what levels of antibodies may be protective from subsequent SARS-CoV-2 infections. It is not yet known whether antibody test results predict immunity to SARS-CoV-2 or how long antibodies last.

Until more information is known, it is important to continue following recommendations for protecting ourselves and each other from SARS-CoV-2, even if antibodies have been detected in an individual. As of April 30, 2020 there is no test approved by the FDA that confirms immunity to the disease.

Medical and research experts are working to determine whether antibodies indicate immunity, and this may take at least six months to ascertain. With this information, Sutter and other healthcare organizations will be better equipped to understand if patients within our communities are at reduced risk of subsequent SARS-CoV-2 infection after previously testing positive for the virus.

This information will help guide decisions around the removal of “shelter in place” directives from county and state government and help determine plans for back to work/school initiatives.

Antibody/Serology Testing at Sutter:
his month we’re also beginning to make available serological tests—or antibody tests. While these tests help detect the presence of antibodies produced in response to the COVID-19 infection, there’s no strong scientific evidence that these antibodies mean a patient is immune to the coronavirus.

Sutter will limit use of antibody testing to highly selective groups and circumstances. For example, the antibody tests will be used to help validate a positive COVID-19 diagnosis with a patient who had previously tested negative but is still suspected to have the virus.

Antibody tests will also be used to determine whether a patient convalescing from a known COVID-19 infection, who is interested in becoming a plasma donor, meets criteria for convalescent plasma donation that could benefit other patients receiving acute care for COVID-19 related disease.

We have sourced cutting-edge serology tests that can quickly and accurately detect hallmarks of the SARS-CoV-2 virus, namely IgG and IgM antibodies. The tests have “high specificity” (>99%).

The specificity of a test refers to how well a test identifies people who do not have a disease. These tests also have “high sensitivity” (>98%); the sensitivity of a test refers to how well a test identifies patients who have the disease. Sensitivity is high when patients are tested >15 days after symptoms of COVID-19 begin. A highly sensitive and specific test can help identify people who have been infected by SARS-CoV-2 virus.

Key takeaways:

  • SARS-CoV-2 serological tests, or antibody tests, are blood tests that are used to detect the presence of antibodies produced by the immune system in response to COVID-19 infection.
  • Information from studies of antibody testing can help understand the spread of the disease and infection rates. However, Sutter does not recommend the use of serology/antibody tests alone for diagnosing or treating people with current COVID-19 infections.
  • There is no evidence yet (as of May 2020) that people with detectable antibodies are immune to re-infection with COVID-19.
  • Until more evidence is available, antibody tests should not be used to make decisions related to easing social distancing or the use of personal protective equipment (PPE).
  • Per guidelines from the Infectious Diseases Society of America (IDSA), serology test results also should not influence decisions regarding return to work until the relationship between antibody presence and immunity is understood.
  • As of May 2020 and according to U.S. federal and California state laws, SARS-CoV-2 antibody tests can only be performed at licensed clinical laboratories.

Shining Light on Mental Health: Research at Sutter Helps Reimagine the Future of Mental Health for At-risk Youth

Posted on May 26, 2020 in Affiliates, Community Benefit, Expanding Access, Innovation, People, Quality, Research, Scroll Images, Transformation

Annie was stuck. Diagnosed with severe depression in her teens, she experienced days where mental illness slowed and dimmed her inner and outer worlds. “I couldn’t move or talk. The most I could do was twitch my fingers. And everything was like I was full of tar.”

Now 23 years old and taking courses in college, treatment and support to manage her depression have helped to open a path for Annie toward freedom and independence.(1)

Annie’s story may be familiar to many. Recognizing Mental Health Awareness Month, consider these statistics:(2)

  • 1 in 6 U.S. youths aged 6-17 experience a mental health disorder each year
  • 50% of chronic mental illnesses begin by age 14, and 75% by age 24
  • Suicide is the second-leading cause of death among people aged 10-34
  • 1 in 100,000 children aged 10 to 14 succumb to suicide each year
  • Depression affects 20-25% of Americans aged 18+ each year

As the novel coronavirus pandemic ushers in uncertainty that may evoke anxiety, depression or other mental health concerns for today’s youth, what would a new vision for their mental health look like? Sutter researchers and their collaborators across Sutter’s integrated network may offer a new path forward.

Early Interventions to Support Youth with Mental Illness
“Suicide cuts short the lives of individuals and leaves the survivors struggling with their grief and efforts to understand,” says Kristen Azar, RN, MSN/MPH, a researcher at Sutter’s Center for Health Systems Research (CHSR). “Healthcare providers can play a significant role in preventing suicide through risk screening and supportive follow-up care.”

Azar helps lead a new study at Sutter on depression and suicide risk.(3) She and CHSR colleague Ellis Dillon, Ph.D., are measuring the effects of a suicide screening tool called the Columbia Suicide Severity Rating Scale (C-SSRS) that was implemented in 2019 across Sutter’s hospitals. The screening tool was selected for its potential to enable earlier identification of people at increased risk of suicide, including people with depression.

The new study will determine if standardized use of C-SSRS across Sutter’s hospital emergency departments, inpatient settings and behavioral health acute care facilities can improve early detection of suicide risk in youth and adults, and help guide follow-up care. C-SSRS is the most evidence-based tool of its kind for early detection of depression and suicide risk.

Azar and Dr. Dillon’s project also seeks to measure suicide screening practices across Sutter ambulatory clinics and hospitals, and hopes to advance the efforts of Sutter’s Anna Kiger, DNP, DSc, MBA, RN, NEA-BC, and Ernell de Vera, RN, MBA, who implemented screening utilizing C-SSRS in the inpatient setting.

“Screening all inpatients by C-SSRS will help us detect at-risk patients early, for early and personalized treatment and support. Further, screening by C-SSRS will facilitate easier reporting and analysis of electronic health record (EHR) data on patient outcomes, strengthening our ability to care for patients with severe depression and those at high risk of suicide,” says Dr. Dillon.

Over the next 18 months the research team will examine the impact of screening patients for major depression and suicide risk using C-SSRS.

“Using this screening tool, we can study how different approaches to screening impact the detection, follow-up care and clinical outcomes of individuals with severe depression or who may be at high risk of suicide,” says Tam Nguyen, Ph.D., director of Ambulatory Care, Mental Health Services & Addiction Care at Sutter, and clinical advisor of the suicide risk screening study.

A New Vision for Youth Mental Health
Beyond screening, helping youth like Annie develop resilience to manage their mental health in their everyday lives may also help reduce suicide risk and decrease the incidence of severe depression among Sutter’s patient population.

Dr. Dillon helps lead a strategy to do so: She and CHSR co-director Alice Pressman, Ph.D., MS, partnered with Sutter Mental Health Services and experts in Sutter’s Design & Innovation team to launch and measure the impact of the project, Youth Mental Health Reimagined.

Supported by a $1 million gift from the Bichofberger family and matching funds from a Sutter Match Grant,(4) “the project embodies our collective vision to meet a clear need for at-risk youth and create a new narrative that eliminates stigma. When we eliminate stigma, we break down the barriers between mental and physical health, and start to remove a huge barrier in access to care,” says John Boyd, Sutter CEO, Mental Health Services & Addiction Care. “Mental health is human health, and we owe it to today’s youth to shape care that’s more engaging and connected to the way they live their lives.”

“We launched Youth Mental Health Reimagined as a response to the growing need for easily accessible and more robust, non-clinical mental health support for teenagers and young adults with depression, as well as their caregivers,” says Dr. Pressman.

Youth Mental Health Reimagined supports patients by providing tools and tips (e.g., a mood tracker, mindfulness exercises, as well as tips for better sleep, nutrition and physical activity) and connections with live docents. Collectively, the approach—dubbed “Scout”, and delivered virtually with people-powered support—provides resources to youth with depression who are receiving primary care or who are transitioning out of acute care settings.

The project will be implemented across inpatient and outpatient behavioral health programs at Sutter’s Mills-Peninsula Medical Center (MPMC) and in some primary care settings at Sutter’s Palo Alto Medical Foundation (PAMF).

“We used human-centered design to create ‘Scout’ as a means to help youth build resilience in real-world settings,” says Chris Waugh, Sutter Vice President and Chief Innovation Officer. “We’re thrilled to offer Sutter patients and their caregivers these resources that leverage research, creative and engaging design, and the top-quality care made possible by Sutter’s integrated network. It’s our way to help make mental health care more engaging and patient-focused, and bring support to people in their everyday lives.”

Although some existing youth mental health programs include a behavioral component and technology-based resources, Youth Mental Health Reimagined is one of the first of its kind in the U.S. to include caregivers in a holistic approach to care.

“Family and other caregivers are an essential part of the treatment and recovery process for young people with severe depression or other mental illness. They can help youth develop coping skills and healthy relationships that build resilience, and help keep them safe during periods of crisis. Youth Mental Health Reimagined gives caregivers a new opportunity to support the youth by helping them navigate ‘Scout’-delivered resources,” says Linda Strassia, Manager of Behavioral Health Clinical Services, whose team at MPMC will recruit youth to pilot test Youth Mental Health Reimagined.

Approximately 300 Sutter patients aged 13-26 years with moderate-to-severe depression and related anxiety will be enrolled to the study through December 2020, with additional patients enrolled in 2021. Two caregivers per study participant will also receive guidance on supporting patients.

Participants will be asked to complete periodic surveys to help the study researchers assess the impact of ‘Scout’ resources on patient outcomes (changes in youth quality of life, social support, physical, and mental health) and on caregiver outcomes (changes in knowledge and behaviors towards providing care and support for youth with depression).

Youth like Annie have the opportunity to experience new outcomes made possible by such mental health support. In her words, “at some point, you have to figure out what tools you have for the situation. So that’s the thing. I think it’s really important for people to have that support structure in their everyday life.”

How Sutter research translates ideas into solutions for mental wellness:

Beyond the projects described above, health systems researchers at Sutter have led other studies to help address potential gaps in caring for people with mental illnesses.(5,6)

Adolescent behavioral health:
Completed in 2018 and funded entirely by community donors, this five-year project evaluated the PAMF Adolescent Behavioral Health program. The study measured changes in primary care provider attitudes toward adolescent behavioral health, uptake of navigation services for adolescents, and uptake and outcomes of care management provided by a nurse practitioner and a cognitive-based therapy intervention called COPE (Creating Opportunities for Personal Empowerment).

Serious mental illness and emergency department utilization:
Azar recently completed research suggesting that subtypes of severe mental illness may predict patterns of emergency department use. The results of Azar’s research were published last year in Population Health Management.

This study showed that patients diagnosed with serious mental illness seek care at multiple emergency departments within a geographic region (versus any one hospital’s emergency department). These frequent utilizers of the emergency department constitute a small percentage of the population but account for disproportionally high healthcare utilization and costs.

“The findings highlight the importance of cross-institutional collaboration between health systems. This includes approaches to share data and analytics, as well as to deliver care that addresses the needs of patients with serious mental illness who frequently visit the emergency department,” says Azar.

References:

1. Annie’s real name was not used in this story, though her story is real.
2. National Alliance on Mental Illness and National Institute of Mental Health.
3. The research study “Suicidality: Examining screening, detection and follow-up care within a large multispecialty healthcare system” is funded by Janssen.
4. The gift from the Bichofberger family will support the Mental Health Reimagined pilot—Sutter Health’s pioneering system-wide engagement to transform the way people in our communities understand and talk about mental health.
5. Yang, Yan, et al. “Primary care provider utilization and satisfaction with a health system navigation program for adolescents with behavioral health needs.” Translational Behavioral Medicine 9.3 (2019): 549-559.
6. Erlich, Kimberly J., et al. “Outcomes of a brief cognitive skills-based intervention (COPE) for adolescents in the primary care setting.” Journal of Pediatric Health Care 33.4 (2019): 415-424.

Study Shines Light on COVID-19 Racial Disparities

Posted on May 21, 2020 in Expanding Access, Research, Scroll Images, Uncategorized

Differences in How People Access Care Contribute to Inequalities

SACRAMENTO, CALIF. – As the COVID-19 pandemic spreads throughout the U.S., evidence is mounting that racial and ethnic minorities and socioeconomically disadvantaged groups are bearing a disproportionate burden of illness and death. Here in California, African Americans are about 6% of the California population, but make up 10.3% of COVID-19 deaths where race/ethnicity is documented.

To better understand how this issue impacts patients in Sutter Health’s network, and to help develop solutions, Sutter’s Advancing Health Equity team undertook a thorough data analysis of the not-for-profit system’s COVID-19 patients. The resulting study, published today by the journal Health Affairs, revealed that African American COVID-19 patients are 2.7 times more likely to be hospitalized than their Non-Hispanic White counterparts, and they tend to arrive at Sutter healthcare facilities sicker and with more severe symptoms.

The findings underscore the fact that race and ethnicity still play a pivotal role in determining how and when care is accessed. Despite having health coverage, African American COVID-19 patients may not seek testing and care until it is an emergency requiring hospitalization.

Stephen Lockhart, M.D., Ph.D.

“The COVID-19 pandemic has ripped a Band-Aid off of the structural inequities that exist within our society – we must address these disparities right away because the cost of not addressing them is measured in human life,” said Stephen Lockhart, M.D., Ph.D., chief medical officer at Sutter Health. “With lives on the line, we as a state can and should do better in connecting minority patients to culturally competent care – that is why Sutter Health has committed to advancing health equity and this study is just one part of our mission and work. We have a moral obligation to do so and must work together to meet this moment and lean into the opportunity to advance health equity for generations to come.”

The study, “Disparities In Outcomes Among COVID-19 Patients In A Large Health Care System In California,” was conducted using Sutter’s electronic health record (EHR) data to characterize COVID-19 tested and confirmed cases by key sociodemographic and clinical characteristics, including self-reported race and ethnicity, across the 22 Northern California counties served by Sutter’s network.

A number of factors uniquely position Sutter to offer early insights into the reasons for the disparities in health outcomes that have been noted nationally. As an integrated healthcare delivery network serving more than 3.5 million patients a year, Sutter had been studying healthcare disparities for close to three years when it became one of the first in the nation to treat patients with COVID-19. And Sutter’s integrated system-wide electronic EHR includes race/ethnicity data throughout its service area, which is one of the most diverse regions of the country.

Sutter Health also operates in an environment that is one of the closest to universal healthcare coverage of any state in the U.S., mitigating one of the known causes of healthcare disparities – unequal rates of medical coverage – and making other factors driving disparities more visible. But coverage is not the same as access, and the higher hospital admissions and mortality rates for African American COVID-19 patients in California revealed by the study illustrate that expanded healthcare coverage is not enough to resolve health disparities.

Kristen M.J. Azar, RN, MSN/MPH

“The real value of the study lies not in the disparities it reveals but in its utility to inform our work to develop solutions that will address the equity gaps we are seeing with programs such as community outreach and engagement in at-risk neighborhoods,” said Kristen M.J. Azar, RN, MSN/MPH, Sutter Health’s lead author for the study and research scientist within the Sutter Health Center for Health Systems Research. “This pandemic underscores the need to develop innovative solutions that are specifically tailored to address the unmet needs of those at highest risk.”

Sutter has extensive experience looking for and analyzing disparities within its own network and beyond.

The results of the COVID-19 study mirror the patterns Sutter observed in a 2017 study about African American patients with asthma and how they access care. The asthma study found 72% of patients drove up to eight miles to a hospital emergency department to access care, even though they lived within one mile of a primary care clinic. We observed they were doing so because of a lack of culturally competent care.

After reviewing the findings of the 2017 study, Sutter developed its Advancing Health Equity Adult Asthma Program. Since the program began in April 2017, nearly 600 African American patients suffering from asthma attacks have been connected to a respiratory therapist to participate in the asthma program. As a result, very few have returned to the emergency room. The asthma program serves as a model for trusted outreach, education and treatment in a public health crisis – and how they can reduce health disparities.

Provider organizations like Sutter Health are on the front lines and, while not able to address all of the complex societal factors at issue, can play a unique role in developing solutions. For example, as part of its commitment to advancing health equity, Sutter developed a novel metric, the Health Equity Index (HEI), to identify and quantify disparities in outcomes across patient groups and develop targeted interventions to enhance equity. Through the HEI, our Advancing Health Equity team is taking major steps, like those detailed here, to build on the benefits of our integrated network of care to further health equity within the Sutter system and across the country.

Our health equity work and the findings of the study released today highlight the importance of community-based outreach and access to culturally competent care within the African American community, which hold the promise of reducing disparities. Additional research is needed to understand where healthcare disparities exist, what drives them, and what targeted interventions work best to address them. Sutter remains committed to continued advancement and leadership in this field.

SARS-CoV-2/COVID-19 Tests: An Educational Series

Posted on May 18, 2020 in Affiliates, Expanding Access, Innovation, Quality, Research, Safety, Scroll Images

COVID-19 tests

Testing is conducted to diagnose, understand and help prevent the spread of SARS-CoV-2/novel coronavirus. We encourage people who test positive for the virus to quarantine and isolate themselves to prevent viral spread to others. This is particularly important with COVID-19, the diseased caused by SARS-CoV-2, because some infected people have no symptoms and may unknowingly infect others.

Follow our Educational Series on testing to learn about polymerase chain reaction (PCR) and serology testing, and stay abreast of the latest updates at Sutter. We feature expert perspectives from Jeffrey Silvers, M.D., Sutter Health’s medical director of infectious diseases. In Part 1 of this series, we describe SARS-CoV-2 testing with PCR.

Overview:
Polymerase chain reaction tests, known as PCR, are the most common and most accurate tests for determining whether someone is currently infected with the SARS-CoV-2/2019 novel coronavirus.

A healthcare provider administers a PCR test by taking a nose or throat swab from a patient, processing the sample in a machine, and then looking for unique genetic materials that indicate the presence of SARS-CoV-2. The test sample is commonly taken from the back of the patient’s throat or nose, generally using a long, thin swab. The swab is stored in a sterile tube and then sent to a lab for testing, where lab testing personnel extract nucleic (genetic) material from the test sample (sometimes called a “specimen”).

The purified genetic material is mixed with other compounds including some derived from the SARS-CoV-2 virus, which are known as “reagents.”

The combined solution is placed in a testing instrument. If a person’s specimen contains SARS-CoV-2, part of the virus’s genetic material will be multiplied several times (amplified) to a high enough level to yield a positive test result—meaning SARS-CoV-2 is detected. The test result is negative, or “not detected,” if the specimen lacks SARS-CoV-2.

As with all lab tests, a number of factors determine the accuracy of a COVID-19 test result. These include not only the instrument and chemical reagents used to perform the test, but also the timing and quality of specimen collection and the biology of the individual patient.

Laboratory tests are characterized by their ability to detect a positive case (sensitivity) and their ability to determine a negative case (specificity). So a sensitive test is less likely to provide a false-negative result and a specific test is less likely to provide a false-positive result.

How accurate are PCR tests?

  • Like most laboratory tests, several factors determine the accuracy of a COVID-19 test result. These include the testing instrument and chemical reagents used to perform the test, as well as the timing and quality of specimen collection and the biology of the individual patient. Laboratory tests are characterized by their ability to detect a positive case (sensitivity) and their ability to determine a negative case (specificity). A sensitive test is less likely to provide a false-negative result and a specific test is less likely to provide a false-positive result.
  • In general, PCR tests are the most effective diagnostic test to detect SARS-CoV-2 infection. However, a follow-up PCR test is sometimes indicated to confirm a negative result. PCR tests are less reliable in detecting very early infections because several days may pass before the virus starts replicating in a person’s throat and nose. Although PCR tests usually convert to negative with 10 days after first becoming positive, they may remain positive in some patients for up to three to six weeks. It is unknown whether this reflects ongoing potential contagion in these extended carriers.
  • The PCR tests are also less reliable with late disease, often starting at about 14 days after initial symptoms, because the virus is no longer replicating and the body is clearing the virus. With optimal sample collection and timing for testing, the PCR test will detect disease in most, but not all, patients with COVID-19.
  • Based on limited studies and according to the U.S. Centers for Disease Control and Prevention (CDC), most PCR tests are highly reliable with less than five percent chance of false negatives.
  • During the course of the SARS-CoV-2 pandemic, PCR testing has been refined from the initial testing procedures and has been conducted with greater automation to help reduce errors.

Are PCR tests administered at home or in pharmacies effective?

  • Rapid point-of-care PCR tests have also recently become available. On April 21, 2020 the U.S. Food and Drug Administration (FDA) approved the first at-home PCR test for COVID-19. The test permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample to a LabCorp lab for testing.
  • The ability to detect COVID-19 disease for home collection depends on closely following the collection instructions and the timing of collection (time point in disease). With optimal sample collection and timing of collection, the ability to detect disease can be similar to collection and testing performed at a healthcare facility.

Testing at Sutter Hospitals:
Sutter Health is following CDC guidelines on testing for SARS-CoV-2 within our hospitals and emergency departments.

As part of Sutter Health’s comprehensive response to the novel coronavirus pandemic, we sourced multiple PCR tests for COVID-19. For the safety of our patients, we continually monitor evidence on newly emerging investigational and approved diagnostic tests, and we run our own performance testing to verify results for effectiveness.

Testing with PCR can produce a positive test result in as little as five minutes, and enables us to perform “close proximity”—conducted on site or nearby—COVID-19 testing for 10 of our hospitals that see the highest volume of patients.

“Close proximity” testing at our busiest hospitals allows us to quickly diagnose and correctly treat our most vulnerable patients, which improves infection-control measures and preserves valuable personal protective equipment (such as masks and gowns) for Sutter’s frontline healthcare workers.

Sutter’s core laboratory in Livermore also supports prompt diagnosis and treatment—delivering COVID-19 test results to our hospitals and outpatient facilities within 24 to 36 hours.

Currently (May 18, 2020), Sutter is performing approximately 1,000 COVID-19 tests daily on samples collected from Sutter patients and employees, and our Sutter labs have the capacity to meet this demand. Indications for testing continue to expand as more testing supplies become available.

We implemented a process that includes repeat testing with an alternative method, on negative test results that do not “fit” with the patient’s clinical picture and other cases when clinically indicated. This helps eliminate suspicion of negative test results.

We are following test manufacturers’ recommendations for optimal swab collection and test performance. Beginning in April 2020, labs affiliated with Sutter have been performing comparison testing to further optimize test performance.

Respiratory Clinics Outside Sutter Hospitals (Ambulatory Respiratory Clinics):
For patients outside the hospital setting, Sutter offers designated respiratory sites where patients can be evaluated by a clinician to see if they meet the criteria for the COVID-19 test. There are respiratory clinics in the San Francisco Bay Area, and designated urgent care clinics in the Sacramento Valley Area.

If you feel ill, schedule a video visit or call our COVID-19 advice line at 866-961-2889 to receive guidance on whether you need to be further evaluated at a Sutter testing site. Please present identification at the testing site to confirm your appointment.

If you meet the criteria for testing, a specimen will be collected and sent to a lab for analysis. If the result is positive, your clinician will arrange for appropriate care.

Testing Locations (Specimen Collection Sites): There are approximately 24 test collection locations, primarily at urgent care locations throughout Sutter’s Northern California service area.

Patients are asked to call a phone number from their car. Staff then provide guidance and coordinate collecting test samples.

Respiratory Clinics: There are approximately 17 respiratory clinics currently located within medical office buildings, clinics, parking garages or tents:

  • Many offer car triage
  • Some require an appointment (a doctor’s note is required for all testing)
  • All of these locations also offer test collection (a doctor’s note is required for all testing)

The test samples that Sutter collects from non-hospitalized patients who have been tested for SARS-CoV-2 are sent primarily to the Sutter core laboratory in Livermore. Results are usually available in one day.

SARS-CoV-2 Testing for Sutter Healthcare Workers:
Sutter is prioritizing prompt testing of exposed, symptomatic healthcare workers to provide prompt treatment, support family safety and foster their safe return to the front lines of care. Our approach is consistent with CDC guidelines.

Part 2 of this Educational Series on SARS-CoV-2/COVID-19 tests describes antibody/serology tests. Learn more.