Safety

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.

Even as Communities Open Up, Keep Your Distance

Posted on May 27, 2020 in Safety, Scroll Images

It may have felt re-energizing to see and hear many Americans gathering at beaches, pools, parks and other public places this past Memorial Day weekend, but health experts caution others to not let their guard down.

“As communities across Northern California start to reopen, we need to remember that COVID-19 hasn’t stopped being infectious,” said Conrad Vial, M.D., chief clinical officer for Sutter Health. “We can’t undermine the physical distancing measures that have been implemented and the impact they have had on slowing the spread of the virus.”

Protecting Yourself, Loved Ones and Friends

Now more than ever, Northern Californians need to remain vigilant about their safety and their health. Bill Isenberg, M.D., Ph.D., Sutter Health’s chief quality and safety officer, shares these important reminders:

• Limit gatherings of any kind. Now is still not the time for parties or potlucks, but virtual gatherings continue to be a viable option.

• Be mindful of your physical space. Always practice physical distancing and stay at least six feet away from others.

• Wash your hands regularly with soap and water or use alcohol-based hand sanitizer.

• Wear a face covering or mask when inside public buildings and businesses.

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.

Respiratory Care Clinics: How Dedicated Exam Spaces Limit the Spread of Viruses

Posted on May 26, 2020 in Carousel, Expanding Access, Innovation, Palo Alto Medical Foundation, Quality, Safety, Scroll Images, Uncategorized

BAY AREA, Calif. – Its second nature for people visit their doctor’s office or an urgent care center when they’re sick — or are worried they might be. In early March doctors across the Sutter Bay Medical Foundation prepared for patient demand at these locations by developing Respiratory Care Clinics (RCCs); an outdoor exam experience that keeps potentially contagious people distanced from those that aren’t, while allowing all who need in-person care to receive it.

“We always knew patients would have concerns that were serious enough to need an in-person exam, but not urgent enough for a trip to the emergency room,” said Kurt Vandevort, M.D., inter-regional medical director for the Palo Alto Foundation Medical Group, part of the Sutter Medical Network. “As community-based providers this middle level of care is our core competency, so it was incumbent on us to find a way to keep providing it, safely.”

By March 16th the Sutter Bay Medical Foundation had established fifteen RCCs in cities across the Bay Area, each seeing patients with COVID-19 concerning symptoms (or who reported a potential exposure to the coronavirus), outside of a nearby medical building that needed to stay open and clean for patients with urgent or medically necessary needs unrelated to COVID.

A month into their operation reporters from The Mercury News and San Francisco Chronicle took notice and wrote about these MASH-like clinics. Now, as Sutter Health resumes more routine patient visits, the RCCs will continue to separate patients with respiratory symptoms from those without, to reduce the risk of exposure to viruses, including the novel coronavirus. Read below to learn more about how the RCCs work and what to expect if you are directed to one.

Call First 

Sutter Health is focused on helping ensure patients have access to the right level of care to match their medical need, but we also understand that sometimes that’s hard for people to gauge. That’s why Sutter Health set up the COVID-19 Advice Line at 1-866-961-2889.

Staffed by a team of nurses from 8 a.m. – 6 p.m., seven days a week, every caller is screened for symptoms linked to coronavirus. Callers are then directed to the most appropriate level of care based on the severity of their symptoms. Patients may be directed to self-monitor at home, to see a provider by video visit or to come to an RCC location where they can receive an in-person exam.

“By linking the RCCs to a pre-screening process (by phone or after a video visit) we can ensure patients coming to RCC do need to be seen in-person, and aren’t ill enough to go straight to the emergency room,” said Dr. Vandevort, who is also the medical director of the RCCs established throughout the Palo Alto Medical Foundation footprint. “When patients arrive at the RCC we also have some information about their chief concerns, thanks to notes entered in our electronic medical record.”

Different, by design 

A physical exam in a parking lot or garage is strange, but the safety that these setting offer is worth the weird-factor. “To protect patients, staff and the community we designed the RCCs to first and fore-most prevent transmission of any virus from a contagious person; that’s why most of them are outdoors and anyone who comes within six feet of the patient is in full personal protective equipment” said Dr. Vandevort. “At the same time we took great pains to try to make the experience similar to what patients are used to when they go to the doctor or urgent care.”

The outdoor RCCs all have a contact-free arrival process, allowing patients to drive-up and call a phone number to “check-in” for their appointment. At every stage of the visit the patient is distanced from others by either staying in their car or in a marked off space within an exam bay.

In addition to an initial temperature check, patients will have their lungs listened to with a stethoscope, have their blood oxygen saturation checked, have their medical history and medications reviewed, and may be tested for coronavirus or the flu if symptoms indicate they should be. Depending on medical need, patients will also receive additional tests and procedures, including imaging scans, blood draws, heart monitoring and more.

The few indoor RCCs are all in buildings, or sections of buildings, that can safely be separated from other areas where patients who don’t have respiratory symptoms are being seen. The indoor RCCs have implemented all the necessary transmission precautions to ensure that spread of a virus from patient to patient or patient to staff is prevented.

Not Just COVID Care

In addition to screening and treating respiratory complaints, the RCCs have filled another important role; addressing non-respiratory related issues reported by patients who have symptoms linked to COVID (fever, cough, shortness of breath). “Just because COVID-19 is here, that doesn’t mean that other illnesses and injuries go away,” said Dr. Vandevort. “One of the best things about the RCCs is that you are being evaluated by a physician who can treat a wide variety of minor illnesses or injuries, prescribe medications or make a dosage change to an existing medication, and otherwise address a whole host of concerns. It’s what we do every day, and in these safe settings, we can keep doing our job even for patients who may have a virus and be contagious.”

In the short time the RCCs have been up and running, doctors staffing them have made unexpectedly important diagnoses and delivered increasingly complex care. “We’ve seen and treated conditions ranging from an appendicitis, to a swallowed fish bone, to an infection requiring IV antibiotics. We’ve done a lot of good.”

Twice the Team 

It’s not easy to run two clinics (one regular and one RCC), simultaneously, just feet apart, but for the safety of our patients and providers that is what we’ve done. “We had to reassign doctors and nurses so we had coverage in both the RCC and the regular urgent care at the same time, some staff now act as a front-door attendants making sure that patients are directed to the right clinic based on their symptoms, and others are runners shuttling supplies between the two spaces.”

All this investment was made for one reason: to prevent the spread of illness. But the RCCs have had several secondary benefits too.

“We’re also helping to preserve hospital capacity by keeping patients from going to the emergency department unnecessarily.” You wouldn’t normally go to the ER for a fever, and the RCCs make sure our smart use of resources stays intact, even during a pandemic.

At the same time, the RCCs have helped refer patients to a higher level of care when that was needed. “Our job is to help stabilize people so they can safely return home, but when their symptoms are serious we help get them to the hospital.”

No Need to Put Off Possible Life-Saving Mammogram Any Longer

Posted on May 19, 2020 in Carousel, Expanding Access, Quality, Safety, Scroll Images, Sutter Medical Foundation, Women's Services

ROSEVILLE, Calif. — Laurie Deuschel of Rocklin received news during the COVID-19 crisis that breast cancer runs in her family, but during the first two months of the pandemic, mammograms were considered elective scans and weren’t being performed. The first week they became available again, Deuschel got an appointment.

“I’m here to have my first mammogram, and I’m a little bit scared,” she said, but she wasn’t scared about catching the novel coronavirus while at the Sutter Imaging center in Roseville Monday, May 18.

Why? “Sutter Imaging knows the cleaning procedures and how to keep me safe,” she said.

Sutter Health is going to great lengths to protect its patients and staff in the COVID-19 era. It has created a “new normal” for its imaging centers, focused on a “safety strategy” that is incorporating guidance from the national Centers for Disease Control, California Department of Public Health and the American College of Radiology. Some of those measures include:

  • Temperature screening of all staff, doctors and patients at the door,
  • Universal masking,
  • Social distancing in waiting rooms (patients can wait in their cars if they prefer),
  • Screening patients at the time of scheduling and arrival for symptoms,
  • Deeper cleaning of equipment after every patient,
  • Regular sanitization of chairs and door handles,
  • Thorough wipe-downs of patient lockers and dressing rooms with a “Cleaned” sign placed for patients and staff to know those areas have been disinfected,
  • Regular audits or “double checks” with staff to ensure that the new procedures are being followed. 

Miyuki Murphy, M.D., the director of breast imaging for Sutter Medical Group, was interviewed for a story on the Sacramento NBC affiliate KCRA, Channel 3. Dr. Murphy explains why not delaying your mammogram is important, and the story includes video of some of the safety measures being taken at Sutter Imaging. Click here for that story on their website.

Dr. Miyuki Murphy on KCRA about the safety of mammograms at Sutter Imaging.

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.