The University of South Florida in Tampa has opened a Zika referral center for patients in advance of the summer mosquito season and the potential for the virus to ramp up again in Florida, similar to 2016.
In the meantime, the cost of screening 4 million blood donations during the height of the Zika outbreak in 2016, where Florida was ground zero, was nearly $42 million, according to a research team for the American Red Cross. The study was published Thursday, May 10, in the New England Journal of Medicine.
At least one scientific group and the Red Cross are calling for the federal government to modify or scale back on the requirement that all blood be screened for Zika.
The Community Blood Center, an affiliate of the NCH Healthcare System in Collier County, has tested all blood donations since August 2016 for Zika with no positive findings, according to Sheila Phillips, the administrative director.
“There has been significant national data collection and analysis during the initial 12-month testing period,” Phillips said. “Based upon those results, industry experts such as the American Red Cross are recommending converting from single-donor testing to minipool screening. The Community Blood Center will continue to follow all regulatory requirements related to Zika testing.”
In terms of the testing cost, the expenses “are simply part of the cost of being able to provide a safe blood supply to our community and patients,” she said.
The Zika referral center at USF opened in April with $600,000 in funding from the U.S. Centers for Disease Control and Prevention. The mission is to help connect patients to a specialty medical team, with a focus on expectant mothers, newborns and infants affected by the disease. Expectant women can pass Zika to their unborn children, which can result in debilitating abnormalities, including microcephaly, a condition characterized by a small head, blindness and other birth defects.
In 2016, the first year the U.S. experienced a Zika outbreak, there were 1,471 cases in Florida with the bulk — 1,122 cases — travel-related. That’s where people left the country and got infected in Central or South America, for example, and came back to the U.S.
There were 300 cases of local infection, spread mainly by sexual contact, and 49 cases where the origin could not be determined.
In 2017 the state had 262 cases, 225 of them travel-related, plus two local infections and 35 cases of undetermined origin.
The new USF Zika referral center is similar to one at the University of Miami Health System, which opened last year. The USF team includes pediatricians, a fetal medicine specialist, an obstetrician, a clinical geneticist, a neurologist and an infectious disease consultant. In addition, a nurse practitioner will serve as case manager of the program.
Zika, a virus transmitted through mosquito bites, is affecting multiple countries in Latin America, and is expected to spread to the U.S.
“Although there are some theories, we still don’t understand all the components of why congenital Zika syndrome burst onto the scene in Brazil in 2015. We do know pathogens are always evolving, so we need to maintain a heightened sense of alertness even when Zika cases decline,” Dr. Patricia Emmanuel, chairwoman of the department of pediatrics at USF’s medical school, who is heading up the Zika referral center, says in a statement.
The USF referral center will accept patients from all over the state, including from Southwest Florida, but it will work with the Miami center to determine the shortest commute time for patients, Emmanuel says.
The center will bill patients’ insurance, if they have it, while the federal grant will cover care coordination and case management that is not covered by insurance, she says.
The Red Cross, which does not collect blood in most parts of Florida, including Naples, supports moving to a minipool nucleic acid test to screen blood donations for Zika in areas that are not experiencing local outbreaks of Zika, according to a Red Cross statement. A minipool would involve samples from 16 donations that are pooled for the test, a Red Cross official said.
In areas experiencing local transmission, testing would immediately convert to testing of individual blood donations, the Red Cross said.
“This screening strategy is consistent with how blood collection organizations use (the nucleic acid testing) in the U.S. for other infectious diseases such as West Nile virus,” Dr. Susan Stramer, vice president of scientific affairs for the Red Cross, says in the statement.
“The use of mini-pool (testing) has been shown to have a robust safety profile for West Nile virus as well as for other blood-borne pathogens,” she says. “This strategy also helps to ensure resources are used efficiently to maintain a readily available blood supply for patients in need. It is important to emphasize that the Red Cross is not advocating for removal of Zika virus screening in the U.S.”
In August 2016 the FDA required all blood donations be screened for Zika, which came after the federal agency allowed blood banks to use the nucleic acid test that was still in investigational stages. In October 2017 the FDA gave its final approval for the test.
The study for the cost to screen blood for Zika was funded by the Red Cross and Grifols Diagnostics Solutions. The study involved 4.3 million blood donations that were screened from June 2016 to September 2017.
The NCH Community Blood Center is one of several Southwest Florida blood centers who recently added an FDA-approved Zika virus test to its screening of blood product donations.
The researchers examined 393,713 donations that were tested in 24,611 minipool screenings, and none were reactive to the virus. In addition, 3.9 million donations were tested individually, and 160 were initially positive, while further screening resulted in nine donations confirmed for Zika, according to the study. In addition, four of the nine positive blood donations had an active window where the virus could have been passed on, according to the study findings.
To calculate the costs, the researchers used a figure of $10 as an average for each nucleic acid test, which works out to nearly $42 million over the 15-month period for the 4.3 million blood donations.
In addition, the projected annual cost to continue the current FDA-required universal screening of Zika using the nucleic acid would be $137 million annually, which will “pose an additional strain on the blood industry,” the study says.
The Red Cross, in its statement, says the data review shows the “current mandated Zika virus screening in the U.S. is both costly and low-yield in comparison to similar infectious disease tests used to screen the blood supply.”
Using a minipool test approach has been shown to have “a robust safety profile” for detecting the West Nile virus and other infectious diseases that can be passed on to others through blood, said Stramer, with the Red Cross.
“This strategy also helps to ensure resources are used efficiently to maintain a readily available blood supply for patients in need,” she said.
Separate from the Red Cross, a scientific panel at Johns Hopkins University School of Medicine in Baltimore published an article in the same edition of the New England Journal of Medicine that addresses whether it is time to modify the Zika screening policy.
The Johns Hopkins group points to no cases of clinical Zika infection tied to a blood transfusion and projected future cost of $137 million a year based on the current screening policy.
“The current U.S. strategy for ZIKA screening comes at a cost with an unclear gain,” Dr. Evan M. Bloch, lead author of the article, said. “There is no doubt that Zika poses a major public health threat. However the actual and perceived risks to the blood supply seem to be conflated.”
The Johns Hopkins group said the decision to test for Zika should “not be condemned” and that a similar proactive response to HIV could have resulted in a dramatically different outcome than the pandemic of the 1980s.
The Johns Hopkins team said the current Zika screening policy needs to be reviewed as new data become available and for key stakeholders to “lead a graceful retreat from a policy decision that thus far has shown limited utility.”
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