Health agencies ensure labs destroy dangerous viruses

No infection reported after deadly flu strain sent to at least 4,000 sites

April 14, 2005|By Julie Bell | Julie Bell,SUN STAFF

Public health officials said yesterday that they had no reports of infection from a potentially dangerous strain of flu virus that was errantly sent to thousands of clinical laboratories worldwide as part of a routine proficiency test.

Still, the World Health Organization, the U.S. Centers for Disease Control and Prevention, and state health officials took no chances yesterday as they followed up efforts to identify and destroy all samples of the potentially deadly H2N2 strain distributed to at least 4,000 hospital, clinical and reference laboratories in 18 countries.

Carol Benner, director of Maryland's Office of Health Care Quality, said 60 labs here had received one or more test kits containing the dangerous strain of flu, which killed at least 1 million during a 1957-1958 pandemic.

Benner's office had called all 60 labs by yesterday afternoon to ensure they had heard about the government's instructions to destroy the flu samples.

At the University of Maryland, for example, officials said lab workers destroyed the virus by autoclaving, a process that involves both high heat and pressure.

"There's always a small possibility that any pathogen can get out of a lab, or that any laboratorian can contract a pathogen that they're working on," said John M. "Jack" DeBoy, director of the state's public health laboratories.

But DeBoy and other public health officials said the chances that a laboratory worker would contract the virus and spread it to others were dimming as the test kits were destroyed and no reports of infection had surfaced worldwide.

Although lab workers handling even common viruses toil at vented lab benches and wear gloves, masks and goggles, the H2N2 virus poses a special danger because it hasn't circulated in the public since 1968. As a result, anyone born after 1968 would have at best limited immunity to it.

"The level [of concern] in this case really reflects, not just what is the risk of the organism being transmitted in the laboratory, but what are the ramifications" if a lab worker becomes infected, said Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

"They now become almost patient zero for the new pandemic," he added, and "it's likely they would transmit widely to others, because it's unlikely those around them would have immunologic protection."

The labs wound up with the dangerous flu strain as part of a government-required program that tests their proficiency at identifying viruses and other pathogens in the patient samples they handle every day.

Private accrediting agencies such as the College of American Pathologists largely administer the program by sending labs unlabeled specimens in test kits, then grading them on whether they correctly identify the contents.

Public health officials were cautiously optimistic yesterday because no outbreaks of H2N2 have been reported since the first test kits were sent out by Meridian Bioscience Inc., a contractor hired by CAP to assemble test kits.

Meridian shipped the first kits containing the H2N2 strain in September. Symptoms of influenza, including fever, a cough and body aches, generally occur within one to two days after infection and likely would have been seen by now, experts said.

Another reason for optimism is that public health laboratories monitor strains of the flu, using samples gathered by physicians and hospitals. They generally notify the CDC when they encounter an unusual strain or one they can't identify, but by yesterday none had done so, said CDC Director Dr. Julie L. Gerberding.

Meanwhile a CAP official said yesterday that the virus Meridian replicated for the kits had been weakened through repeated use as a laboratory reference sample.

It was therefore considered safe by those who sent it out, even though they knew it was the H2N2 strain, said Dr. Jared N. Schwartz, CAP's secretary-treasurer.

Nevertheless, experts called distribution of H2N2 a lapse in judgment that put millions at risk. Health officials are still trying to sort out who made that decision at the Cincinnati-based company.

CDC officials said they learned about the problem from a Canadian lab that identified the H2N2 strain. CAP officials said they had not heard of any problems until they were notified by the CDC on Friday.

"The CDC asked us to notify labs and destroy any remaining specimens, which we have done," Schwartz told reporters yesterday.

Meridian shed no light yesterday on how the problem came to pass and mentioned H2N2 briefly in the closing paragraphs of a news release announcing the company's preliminary earnings. Its stock gained 4 cents yesterday, closing at $15.12 on the NASDAQ market.

"The company has a long history of supplying samples to the CAP and believes it has been and is in compliance with all applicable regulations," Meridian's statement said.

The CDC's Gerberding said her agency, which has limited regulatory authority over labs, will work with CAP and other accrediting agencies to come up with guidelines to prevent a recurrence.

That plan drew praise from a variety of experts. "I feel fairly confident we really dodged a bullet," said Minnesota's Osterholm.

"We need to make absolutely sure it doesn't happen again."

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