When doctors suspected a patient hospitalized at UCI Medical Center in early March might have COVID-19, the only test option was through Orange County’s already inundated public health department.
That left UCI Health doctors, nurses, staff and other patients without vital information just as the novel coronavirus crisis was hitting Southern California.
The health of everyone seemed to hang in the balance.
The delay led Edwin S. Monuki, MD, PhD, the head of UCI Health Pathology and Laboratory Services, to resolve to get a useful COVID-19 test up and running as quickly as possible.
‘Mad dash’ to establish in-house test
“Orange County’s public health department was able to test our patient, but after that it was a mad dash to establish the test in house,” said Monuki, professor and chair of UCI School of Medicine’s Department of Pathology & Laboratory Medicine.
Such an effort is what an academic medical center is made for, where leading pathologists are able to work with virologists and basic scientists on the university campus in Irvine to mount a concerted effort to protect patients and combat the worst disease outbreak to hit the United States in a century.
Complicating matters, the Orange County health department was using a test developed by the U.S. Centers for Disease Control and Prevention (CDC) and distributed to health departments nationwide. But testing got off to a slow start nationally because the kits contained a faulty reagent, one of the chemicals used to test patient samples.
Monuki’s team, together with hospital leaders, reached out to medical companies with whom they had long-established relationships to bring a reliable test to the UCI Health lab.
Preparing for testing
They found a test, but the pathology lab needed new equipment to run patient specimens. Swift approval was given March 6 to buy the instrument, and both the equipment and testing materials arrived the next week.
The UCI Health team rapidly validated the new instrument and test, and the medical center became the first hospital in Orange County to provide in-house COVID-19 testing on March 19 — more than two weeks ahead of schedule.
At the time, the pathology lab had only 19 test kits on hand, said Cassiana E. Bittencourt, MD, director of the microbiology lab where the testing occurs. Fortunately, they already were validating a second reliable test – this time using instruments already in the lab.
By March 23, both tests were available to meet an anticipated wave of seriously ill COVID-19 patients.
“Being able to bring up two COVID-19 tests quickly and ahead of schedule was crucial, which would not have been possible without a decisive UCI Health leadership and our tireless microbiology lab team, which was nothing short of amazing,” Monuki said.
What is the COVID-19 test?
Typically, a specimen is gathered by swabbing deep in a person’s nasal cavity. The specimen is placed in a vial containing transport fluid and sent for testing. Using sophisticated testing platforms, technicians examine the specimen for the presence of nucleic acid from the novel coronavirus, officially named SARS-CoV-2, which causes the COVID-19 disease.
“A positive result means the person has the COVID-19 disease and is probably infectious,” Monuki said. “People who test positive need to quarantine themselves and take precautions against spreading the disease.”
No test is perfect, however. The COVID-19 tests being conducted around the nation can have a “false negative” rate of about 25%, which means that infected patients can test negative as much as 25% of the time.
There are many reasons for the high rate of false negatives, including the disease stage in the patient, the sampling of only one body site and the challenge in getting a good specimen from the nasal cavity.
“Fortunately, clinicians detecting and treating the disease have other signs and clues that a patient has COVID-19,” Monuki said.
Widespread testing begins
Once the pathology team was able to boost production in early April, UCI Health expanded COVID-19 testing, including for all pregnant women about to give birth to ensure the health and safety of each mother, child and healthcare worker.
UCI Health teams also opened a drive-up station at the medical center in Orange to safely test patients who needed essential surgery, cancer infusions or other medical care that could not be postponed. Soon a second drive-up station opened at Gottschalk Medical Plaza in Irvine.
The pathology team also developed two additional platforms so that highly reliable test results could be delivered within 1 to 2 hours.
Today, UCI Health is on track to process about 1,000 samples a day. This makes it possible for Monuki’s team to test what other healthcare providers in the area cannot:
- All hospitalized patients
- All nursing home transfers
- All patients undergoing outpatient procedures, such as colonoscopies and surgeries that don’t require overnight stays
- Patients of affiliates and community partners
How to get tested
UCI Health continues to offer drive-up testing by appointment at the medical center in Orange and in Irvine. To reserve a spot, call the triage line at 714-456-7002.
The process takes about 10 to 15 minutes to gather required information and a good specimen from each drive-up patient. Results are available within 24 hours.
Initially, appointments were given only to people with COVID-19 symptoms or those who had been exposed to someone with the disease. As more testing has become available, more people are able to get one.
Still, at this stage of the pandemic, a COVID-19 test may not be appropriate for everyone, according to Monuki.
There are practical reasons not to test everyone,” he explained. “Asymptomatic people can have the virus, but if everyone without symptoms were tested, the vast majority would be negative. This wouldn’t be very helpful right now, and it would certainly strain available resources.”
Antibody testing and more
The pathology lab also has begun testing people for antibodies to the virus. It involves studying a blood sample for the presence of proteins the body makes to fight SARS-CoV2, which would mean a person had been exposed to the virus. But infectious disease experts don’t know whether having antibodies to the virus results in immunity to reinfection.
UCI Health also has numerous clinical trials underway for COVID-19 treatments, including the recent FDA-approved drug remdesivir. Other researchers are collaborating on potential vaccines and studying the spread of the disease.
Although a huge surge of COVID-19 patients has not materialized so far in Orange County, the need to determine how many people may harbor the virus and where they are will be essential for society to resume work, school and other social activities.
Monuki’s team is expecting to expand testing further to help the university re-open its doors to students for the fall quarter.
“Once we get past this initial wave of patients, the approaches for getting back to a normal way of life will probably include much more testing of asymptomatic contacts and people in general,” he said.
“Testing, tracking and isolating people who have been close to someone infected with the virus will be a critical part of the effort to control this disease.”