University of Maryland adopts new technology to diagnose sick children
It was a family's worst nightmare: A sick newborn sent home from the hospital by doctors who thought she had a common cold dies of a viral infection.
Since Rebecca Rabinowitz died in 2006 at 9 days old, her family has searched for a better diagnostic tool for infants. One method they helped uncover will be put to the test Monday in Maryland.
That's when the University of Maryland Medical Center will begin swiping the noses of children to diagnose quickly up to 10 common viruses that lead to hospitalization of hundreds of thousands of children in the United States each year. The procedure could save critical time for vulnerable newborns, as traditional tests could take weeks.
The technology was purchased by the New Jersey-based R Baby Foundation, a nonprofit named for Rebecca. Grandparents Henry L. Belsky, a Baltimore attorney, and his wife, Brenda, helped raised the $135,000 for a machine and tens of thousands more for its use and research.
"The technology wasn't available for Rebecca," Henry Belsky said. "But other kids can get a diagnosis and be treated and kept alive long enough to recover."
The test will look for viruses that cause some of the world's most common respiratory illnesses, including the common cold, influenza, bronchitis, croup and pneumonia. With the new testing, the medical center hopes to identify the dangerous viruses within 24 hours.
At most hospitals now, if tests are done, they are less sensitive and less reliable. Or they are done manually, growing individual cultures and taking up to two weeks for results — time many sick babies might not have.
The Belskys and the scientists involved in the research want to eventually expand access to the technology to Baltimore-area community hospitals and beyond.
That's what makes this effort different. The technology isn't new. It's used by some university hospitals doing limited diagnoses, scientists doing research and public health labs keeping tabs on infectious disease outbreaks. With this type of technology, state health officials confirmed 45 deaths from H1N1 flu last season, including five children.
University of Maryland doctors, who were given both a challenge and funding by the Belskys' foundation, hope their system can be used more generally, though they acknowledge obstacles and say the effort is a work in progress.
Dr. Steven J. Czinn, professor and chairman of the department of pediatrics at the University of Maryland School of Medicine, said transporting the patient specimens quickly to the lab could be logistically difficult and costly. Swift results could be crucial, however, because some antiviral medication is effective only when administered within 48 hours of the first symptoms.
Doctors will need extensive training to recognize when the test is appropriate. Czinn said the lab aims to test those in the "gray area" — not children likely to recover without intervention or children so sick that treatment is obvious.
Scientists have been working with the technology to ensure that they are practiced enough with the complex procedure to produce consistent, quality results. The machine's multi-virus testing technology was approved by the U.S. Food and Drug Administration in 2008, but those who are inexperienced can easily contaminate specimens or turn up false positives, doctors say.
For now, it's unclear how often the test will be used. Maryland doctors will begin accepting specimens Monday, and over time parameters will be developed to guide doctors.
"We don't want the lab to get 300 samples an hour," Czinn said. "We don't want all children tested. But we want it to be available. We'll have to educate practitioners in the emergency rooms around the state."
For those getting the test, a process called polymerase chain reaction, or PCR, it will start with a nose swab, said Dr. J. Kristie Johnson, an assistant professor and associate director of clinical microbiology at th medical school's department of pathology.
In the lab, nucleic acids are separated from cells on the swab. They are mixed with reagents designed to bring about a reaction, and the resulting acids bind into beads that are read by the machine as types of viruses. The machine at Maryland is made by Luminex, though other companies have similar technology.
"Under the current method, we look at cells to see if they are infected with virus under a microscope, but it can take days for the cells to be damaged by viruses — 48 hours to 14 days," Johnson said. "This one reaction is a lot quicker. We can run it every day or even more often if we have samples."
That will help doctors needing more information, which they can't always get from the state lab. The mission of the public lab is surveillance and not diagnosing patients, said Naomi Barker, a developmental laboratory scientist at the state Department of Health and Mental Hygiene.
She said time and costs are factors. Tests cost from under $100 to $200 per specimen, depending on how many samples are tested at once.
Initially, when the multivirus test was FDA-approved, Barker thought all hospitals would get the technology. But it soon became clear the expense and need for expertise in using it would be limiting.
During last flu season, officials first tested a limited number of specimens that came in from hospitals participating in the state's surveillance program only for flu. And they were only from very sick patients and those who died — about 6,000 last year and "only the tip of the iceberg," she said. The multivirus tests were saved to identify other outbreaks.
"We wanted to know what was circulating in the community; we weren't trying to treat people," Barker said. "[University of Maryland] won't be able to test everyone either; they will need to choose their criteria carefully. ... There is potential for good public health impacts. We're hopeful for them."
Other leaders at the Department of Health and Mental Hygiene say they'll be watching. As will Dr. Alexandra Valsamakis, director of clinical virology and molecular biology at Johns Hopkins Hopsital's ' department of pathology. She spent five months last year determining how Hopkins could use the technology. There was much discussion with the doctors about whom to test.
Now, Hopkins uses the multivirus test only on those at risk of severe respiratory disease because of impaired immune systems, such as those with cancer or HIV, in intensive care or pregnant. The lab offers the test six days a week during the colder months, when respiratory disease is most common, and three days a week at other times.
"We spent months refining this," Valsamakis said. "If [Maryland] can figure out how to make it work operationally regionwide or statewide, it would be great. They won't be able to throw the switch for all pediatric patients, but if they manage to get that gray zone or those critically ill, and they can do quickly, it'll be a great clinical service."
At Maryland, the goal is to run the machine once a day with potentially dozens of patients' specimens, according to Johnson. In colder months, or as need rises, the frequency would rise.
The costs aren't clear, but the hospital hopes to collect some insurance reimbursements for the test. For now, it isn't likely to be a moneymaker for the University of Maryland, which already serves as a safety net for those who can't pay for care, the doctors said.
Effective treatment of sick kids remains the goal, for the doctors and the Belskys.
"If we save one life," said Brenda Belsky, "it'll be worth it."