A “false” positive hepatitis test leaves no answers for local plasma donor

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JOHNSON CITY, TENN. (WJHL) – Everything seemed normal when Cherrie Rosenbaum went to donate plasma in Johnson City last week.

She arrived at Plasma Biological Services to donate – business as usual for the past eight years.

However, after she checked in, staff members called her back to tell her she could never donate plasma again.

Rosenbaum said staff told her that Hepatitis B showed up in her blood screening. She signed an acknowledgment waiver and made an immediate appointment with her doctor.

Her doctor told her that her Hepatitis B test came back negative.

“My first reaction was, ‘Why are they doing this?'” She said. “I know I don’t have no hepatitis or anything like that.”

Cherrie Rosenbaum said a positive Hepatitis B test has barred her from ever donating plasma again.

Rosenbaum said staff members at Plasma Biological Services refused to give her any paperwork stating that her screening tested positive for Hepatitis B. Now, she said she’s left with no answers and no way to donate plasma, which she sometimes does to make ends meet.

“It was a helpful source of income, and it’s really hard toward the end of the month, but it was more towards donating, saving people’s lives,” she said.

A postive test plus a negative test equals . . .

Heather Mullins, the regional epidemiologist for the Sullivan County Health Department, said a couple of things can happen to cause what appears to be a “false positive” hepatitis test.

For Hepatitis C, Mullins said a sample will first be tested for antibodies to the virus. She described antibodies as the body’s warriors that are created to fight an infection like hepatitis.

A presence of Hepatitis C antibodies, she explained, means that the body was exposed to the virus in the past. The next step is to test for the presence of the virus by searching for its genetic material in the blood.

The outcome of the second test determines whether the patient has an active Hepatitis C infection.

Sometimes, Mullins said, the first test will be positive and the second test will be negative.

“That means your body has probably cleared the infection of Hepatitis C,” she said, adding that there is about 15-25 percent of the population who can naturally fight off the infection.

“Those Hepatitis C antibodies will always be in your system, even if you cleared the infection or not,” she continued. “That’s pretty much showing evidence that you had exposure to that virus at some point in time in your life.”

Sullivan County Regional Epidemiologist Heather Mullins explains how Hepatitis screenings work.

Things are a little bit different for Hepatitis B, which is what Rosenbaum thought she had. Mullins said there are about five different indicators that would trigger a positive result on an initial test.

While there is no vaccine for Hepatitis C, vaccines for Hepatitis A and B could potentially trigger a positive result on the antibody test, she said.

“(A positive antibody test) can say that this person had the vaccine, they’ve never been exposed, but they’ve had the vaccine,” she said, continuing,
“It can say that they’re currently infected, or they’re chronically infected, or that they’ve recovered from the illness.”

Mullins said it’s important for doctors to follow-up an initial screenings to determine whether a patient has an active infection, a chronic infection or if the body has cleared itself of the illness.

Rigid regulations

Dr. Mark Fowler, medical director for Interstate Blood Bank (the parent company of Plasma Biological Services), said that cases like this happen about two or three times a year across 34 collection centers and tens of thousands of specimens.

Plasma centers across the nation adhere to strict Food and Drug Administration guidelines when it comes to giving potential donors the greenlight. Those guidelines include barring anyone with a history of hepatitis from ever donating again.

Testing positive on the initial screening will place a donor on a national list that permanently bars them from donating plasma, even if there is no genetic material of the virus detected.

“The list of disqualifying factors are extensive,” Fowler said. “The list goes on and on and on of things we look at and test.”

Officials with Plasma Biological Services’ parent company say that plasma centers have to adhere to strict FDA regulations.

FDA regulations say no one with a “history” of hepatitis may donate plasma, and Fowler said a positive antibody test registers as a “history” of the infection.

He described the centers’ plasma screening tests as “exquisitely” sensitive – designed so for safety, but that means some get stuck in the cracks.

“The more sensitive your test, the higher the false positives, which means it’s going to catch everything that happens,” he said.

Still no answers

Rosenbaum said when she got tested at her doctor, her tests came back negative for both the virus and antibodies.

She said she hasn’t had any luck getting paperwork from Plasma Biological Services concerning her positive screening.

Fowler said the point of screening donors isn’t to provide any diagnosis, but to eliminate the transmission of any infection to the end product, which can include medicines and treatments for people with conditions like hemophilia and primary immunodeficiency.

“We have no provider-patient relationship with (donors),” he said. “The purpose of testing is to protect the blood only.”

He also said the FDA is stringent on which tests plasma centers may use for screenings and that centers can’t accept tests from outside doctors or any other source.

Rosenbaum said she’s had a Hepatitis B shot, but said it doesn’t explain that she was able to donate the week before she was told she tested positive for the virus.

She also said her brother was told he couldn’t donate for a year because of her positive test.

“I feel like they’re discriminating,” she said.

Dr. Fowler said any time a batch of tests has several tests come out positive, the lab will re-run the tests if there are “unusual positive results.”

“This is all done with a view of protecting the public,” he said.

Copyright 2019 Nexstar Broadcasting, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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