CAP Laboratories Alerted to Destroy an Influenza A Specimen Included in Some Proficiency Testing Kits
Published on: April 13, 2005
On April 8, the CAP was alerted that a potentially hazardous influenza A specimen, H2N2, which was provided by a CAP contractor, Meridian Bioscience, was shipped in the second half of 2004 and early 2005 to laboratories enrolled in CAP proficiency testing (PT) programs.
CAP immediately notified 3,747 proficiency testing laboratory customers who received the samples to destroy them immediately and to report back to the College on that action.
Although the risk to laboratory workers and the general population is low, the College is continuing to work with the Centers for Disease Control and Prevention and the public health community to ensure all samples are destroyed in a proper manner and that this event is not repeated.
Meridian manufactured the specimens on behalf of the College and three other PT providers: the Medical Lab Evaluators, the American Association of Bioanalysts, and the American Association of Family Practitioners. At the time the influenza A specimen was provided, Meridian understood that the specimen was still a Biohazard Safety Level 2.
It is against CAP policy to use micro-organisms or other materials associated with a risk of potentially causing harm in its proficiency testing products, and the CAP is working with the CDC and College contractors to ensure that all CAP PT products meet that standard.
CINCINNATI--(BUSINESS WIRE)--April 13, 2005--Meridian Bioscience, Inc., (NASDAQ:VIVO) today announced that, based on preliminary results, it expects to report net sales of approximately $23.5 million and diluted earnings per share of between $0.19 and $0.20 for the quarter ended March 31, 2005. For the same period of the previous fiscal year, sales and diluted earnings per share were $20.94 million and $0.15, respectively. The Company will report its final results for the fiscal second quarter on April 21, 2005. Meridian Bioscience also reaffirmed its guidance for the fiscal year ending September 30, 2005, of sales between $84 million and $88 million and diluted earnings per share between $0.66 and $0.70.
Commenting on the recent reports in the general press regarding the recommendation by the World Health Organization (WHO) that testing laboratories destroy proficiency samples containing influenza A virus, the Company noted it produces such samples for the College of American Pathologists (CAP). Such samples are used by professional laboratories accustomed to handling viral agents. For fiscal year 2004, the Company's CAP sales and operating income were approximately $3.0 million (4% of total sales) and $750,000 (5% of total operating income), respectively. 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. Further to this topic, the Office of Communication for the Centers for Disease Control stated, in part, in their media relations statement dated April 12, 2005:
"On 8 April, after a request by the US government, CAP asked all laboratories which participated in the proficiency testing to immediately destroy samples containing the H2N2 virus. On 12 April, a second correspondence from CAP to these laboratories further requested that destruction of the H2N2 virus be confirmed and that any case of respiratory disease among laboratory workers be investigated and notified to national authorities. WHO has received the list of addresses of the involved laboratories and has provided detailed contact information to the relevant Ministries of Health and requested their collaboration.
As of today, there have been no reports of H2N2 infections in laboratory workers associated with the distribution of the H2N2 samples from CAP. The proper use of biological safety cabinets, along with the use of recommended personal protective equipment, greatly reduces the risk of laboratory-acquired influenza infections. While a few H2N2 laboratory acquired infections have been documented in the past, the likelihood of laboratory-acquired influenza infection is considered low when proper biosafety precautions are followed. The risk for the general population is also considered low.
As a precautionary measure, WHO is recommending that all samples of the proficiency testing panel from CAP and any other proficiency testing providers containing H2N2 and any derivates be destroyed immediately. WHO further recommends that biosafety procedures be reviewed for use on influenza viruses that have not circulated recently in humans and against which the majority of the population would have no protective immunity."
FORWARD LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements which may be identified by words such as "estimates", "anticipates", "projects", "plans", "seeks", "may", "will", "expects", "intends", "believes", "should" and similar expressions or the negative versions thereof and which also may be identified by their context. Such statements are based upon current expectations of the Company and speak only as of the date made. The Company assumes no obligation to publicly update any forward-looking statements. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ, including, without limitation, the following: Meridian's continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian's competition. While Meridian has introduced a number of internally developed products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Costs and difficulties in complying with laws and regulations administered by the United States Food and Drug Administration can result in unanticipated expenses and delays and interruptions to the sale of new and existing products. Changes in the relative strength or weakness of the U.S. dollar can change expected results. One of Meridian's main growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and the acquired businesses successfully integrated into Meridian's operations.
Meridian is a fully integrated life science company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral, and respiratory infections. Meridian diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents and specialty biologicals along with proteins and other biologicals used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices and diagnostics manufacturers in more than 60 countries around the world. The Company's shares are traded through Nasdaq's National Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
CONTACT: Meridian Bioscience, Inc.
John A. Kraeutler, 513-271-3700
SOURCE: Meridian Bioscience, Inc.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Meridian Bioscience, Inc's business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.
Scientists hunt thousands of vials of deadly flu virus sent across world
Strain not seen since 1957 could pose danger to laboratory staff
Sarah Boseley, Luke Harding and Suzanne Goldenberg
Thursday April 14, 2005
The Guardian
Scientists in 18 countries are tracking down and destroying thousands of vials of a lethal virus which, if it escaped, could trigger the long-feared global flu pandemic, the World Health Organisation said yesterday.
The samples of virus H2N2, which caused 4 million deaths in the 1957 flu pandemic, were sent to more than 3,700 laboratories by a leading American medical institution several months ago.
Yesterday, it emerged that the potentially deadly distribution was discovered only through a combination of luck and human error at a laboratory in Vancouver, Canada. The original mistake was made in October last year in Northfield, Illinois, a suburb of Chicago, home to the headquarters of the College of American Pathologists.
The college sends out standardised flu testing kits to labs around the world, each containing vials of different strains of flu virus to enable technicians to ensure that their own testing equipment and reagents are working properly. This time included with the modern strains of flu virus was the killer Asian flu known as H2N2.
The virus went to Bermuda, Belgium, Brazil, Canada, Chile, France, Germany, Hong Kong, Israel, Italy, Japan, Lebanon, Mexico, the Korean Republic, Saudi Arabia, Singapore, Taiwan and labs in the US.
In Vancouver, British Columbia, technicians ran a sample from the panel containing H2N2 under the same flume hood as a sample from a patient - a practice that would not be allowed in many laboratories because of the risk of contamination, Frank Plummer, director of the National Microbiological Laboratory said.
The patient sample became contaminated. "The panel sample has very very high level of virus," Canada's chief public health officer, David Butler-Jones, said. "There was enough that it gave a low-level positive result in the patient sample."
Mr Plummer went on to reveal that the patient in Vancouver was not suffering flu symptoms, and the test was administered as a matter of routine. The sample then was forwarded to the national laboratory - again a matter of pure chance as regional facilities generally send only 25% of their samples for the more detailed analysis capable of identifying the flu strain as the deadly H2N2. "There is certainly a kind of irony here," Mr Plummer said yesterday, "but it is a happy sort of error."
The result - indicating the presence of H2N2 in a human for the first time in nearly 40 years - triggered an investigation. The patient was retested and found not to have H2N2, and the source of the contamination was traced to the panel on March 26.
Klaus Stohr, who heads the World Health Organisation's influenza programme, said the virus could cause a global flu outbreak. "It was an unwise decision to send it out," he said.
Asian flu did its deadliest work in 1957, until populations began to develop immunity to it and vaccines were developed. The strain lingered until 1968, vanishing as the next pandemic arrived - Hong Kong flu, or H3N2.
This means that people born after 1968 have not developed immunity to H2N2.
John Oxford, a professor of virology at the Queen Mary School of Medicine in London, said this could pose a problem to the labs that received the testing kits: "You tend to give this kit to the youngest, most unqualified person because it is all very simple," he said. "That young person is the most susceptible. Anyone younger than 36 or 37 would have no immunity."
The WHO said there was no need to panic: "It is a risk, but it is considered low. It should not lead to a big scare," Dr Stohr said. Professor Oxford agreed, but said that if labs knew they were dealing with H2N2, they would treat it with greater respect than other strains. "It is a potential pandemic virus," he said. "If somewhere in the world it gets out, it will be on our doorstep tomorrow morning."
The kits were usually sent out in the ordinary mail, he added. "We are allowed to send viruses in the post as long as they are wrapped in absorbent paper."
Some labs may not have thought the arrival of H2N2 remarkable, he said. "Most labs would say, 'Oh yes, an old fashioned virus'. But at the cutting edge of influenza, there is already uncertainty about H2N2 and discussions about it and the feeling that it might turn into a pandemic and we should be careful."
There were two pieces of good news, he said: that this would make labs more careful of H2N2 and that the British government had stockpiled the drug Tamiflu, which works against this strain.
Canada may have been the first country to have realised the potential danger, because they are particularly on the alert and prepared for emerging diseases after the Sars outbreak. After the discovery, the Public Health Agency of Canada alerted the WHO, which instructed all laboratories to seek out and destroy all stocks of H2N2 received in testing kits from the American college.
Yesterday, the four European countries to have received the virus - Germany, France, Belgium and Italy - moved swiftly to destroy it. Health officials in Germany said the US company had supplied six laboratories with the virus in the states of Bavaria, Baden-Württemberg and Rheinland-Palatinate. The labs destroyed the samples yesterday, officials said, after a directive from the country's health ministry.
Susanne Glassmacher, a spokeswoman for the Robert Koch Institute in Berlin, said: "The risk for the general population is very slight. The labs that got the H2N2 virus are used to dealing with dangerous virus samples. These are experienced diagnostic laboratories and they don't always know what they are getting. They are always pretty careful."
According to health officials in Europe, the laboratories had been expecting to receive the far more common strain of modern flu virus H3N2. It was not clear last night whether the laboratories were aware before the alert was issued that the samples contained the far more dangerous 1957 H2N2 strain.
According to the WHO, four countries had destroyed all their stocks - Canada, Hong Kong, Singapore and Korea, while Taiwan was moving quickly. In America, where the bulk of the virus samples were sent, Julie Geberding, director of the Centres for Disease Control, said most laboratories had destroyed their samples.
I wonder how they destroy it. Do you know?
Getting rid of the specimen was handled by putting it in a sealed container and autoclaving it at very high temperatures. To insure that the temperature was high enough, we also included a control spore to prove that killing was totally effective," says Dr. Amy Gewirtz, OSU Medical Labs Director.
MSNBC.com
Two shipments of deadly flu missing, WHO says
Two-thirds of viral samples destroyed; search continues for others
The Associated Press
Updated: 1:21 p.m. ET April 15, 2005
GENEVA - Health experts have destroyed two-thirds of the specimens of a killer influenza virus sent as part of routine test kits around the world, but were still trying to trace two shipments that were supposed to go to Mexico and Lebanon, U.N. officials said Friday.
The World Health Organization has been urging thousands of labs in 18 countries which received vials of the nearly 50-year-old H2N2 virus to destroy the samples amid fears of a global pandemic should the virus be released.
WHO influenza chief Klaus Stohr said 10 of the countries which had received samples had confirmed their labs had destroyed the virus. Labs in Lebanon and Mexico, however, "never received the specimen even though they were on the distribution list," Stohr said.
Investigation into missing test kits
He said it was possible the shipments had never been sent out at all, but he could not be sure. WHO has requested an investigation into the missing kits, he said.
Stohr said Hong Kong, Belgium, Singapore, Canada, Chile, France, Germany, Italy, South Korea and Taiwan had all confirmed their labs had destroyed their samples.
The five other countries with labs that received the kits were Saudi Arabia, Bermuda, Brazil, Israel and Japan. Stohr said Saudi Arabia had five labs with samples; four had already completed the destruction of the virus.
The other four countries had not yet sent confirmation but had received instructions to destroy the virus.
Most of the samples were sent starting last year at the request of the College of American Pathologists, or CAP, which helps labs do proficiency testing. The last shipments were sent out in February. It wasn't clear when the shipments were supposed to have gone to Mexico and Lebanon.
"We don't know where these boxes got lost, but the investigation into what has happened between the shipment of these panels and their non-arrival is ranking very high on our 'to do' list," Stohr said.
"We are worried, but CAP said there is a possibility they were never sent. (Otherwise), I cannot say at this stage what we would possibly do," Stohr said. "The carrier, the transporter and packager would have to be questioned particularly about these packages."
© 2005 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
© 2005 MSNBC.com
URL: http://www.msnbc.msn.com/id/7515802/
MSNBC.com
Was deadly flu deliberately sent to laboratories?
Officials unclear why lethal strain of viruswas included in test kits
MSNBC News Services
Updated: 12:19 p.m. ET April 14, 2005
WASHINGTON - Federal officials are still at a loss to explain how a potentially deadly strain of influenza was sent to more than 4,000 labs around the world...
http://www.msnbc.msn.com/id/7497874/
MSNBC.com
Killer flu samples shipped via FedEx, DHL
Debacle sheds light on byzantine system for transporting germs
So a little deadly virus slipped out of the lab -- no big shock there
The deadly virus mass-mailing got back-paged probably because the Centers for Disease Control said that nobody has been infected.
By John Bogert
The deadly virus mass-mailing got back-paged probably because the Centers for Disease Control said that nobody has been infected.
So for heaven's sake don't worry just because Meridian Bioscience Inc. of Newton, Ohio, (currently not returning phone calls) has been busily mailing lethal viral test kits to labs all around the world.
This is routine stuff really, nothing at all. Sponsored by the college of American Pathologists and other organizations entrusted with our health, mailings of relatively harmless viruses are supposed to keep labs on their toes. It's virus ID practice.
Only this time a small error was made. Instead of sending a relatively harmless virus, the lab sent 5,000 samples of a virus called H2N2. Those of you who were not alive in 1957-58 are probably not familiar with this little guy then affectionately known as Asian flu.
I caught H2N2 and spent two weeks suffering fever hallucinations so bad I actually remember them and my mother crying and the doctor coming and going (doctors were much nicer back then and helpless). I nearly died. A million people actually did.
That's how deadly H2N2 is. And virologists agree that anyone born after the disease burned itself out in 1968 has little or no resistance to the thing. People born after 1968 would, of course, include most of the world's population.
But let's see some smiles out there and a big old, "Wow, that was a close one." Besides, this virus that somebody thought should be kept alive for fun like we keep Sirhan Sirhan is in the hands of experts like Jan de Jong at Erasmus University in the Netherlands.
The flu expert told the Associated Press that labs are used to dealing with such lethal microbes and are set up to avoid releases of the non-mail order type.
"We have this virus in our refrigerator," he said, reassuring a public that knows mistakes can occasionally happen but not -- as in this case -- 5,000 times over seven months.
Still, I felt better knowing that an invisible killer is safe in this guy's refrigerator right between some leftover pizza and a bottle of Trader Joe's orange juice.
Clearly, there is no reason not to trust a test system that doesn't actually prohibit the mailing of deadly viruses. Still, there was one troubling incident. Or an incident troubling to me, a cynic that doesn't completely believe in the infallibility of refrigerators. Last month a hospital in British Columbia sent a patient blood sample to its national lab in Winnipeg where it was identified as H2N2.
But guess what, the patient didn't have H2N2. The sample had just been contaminated by being stored in proximity to the virus. OOOPS! So take a deep breath, preferably in a sealed room because the CDC has -- despite insisting that their worldwide mailing poses only a slim chance of contamination -- recommended that anybody "showing symptoms should be immediately tested."
That of course is just a precautionary statement. By the way, the virus, the CDC claims, can be "easily destroyed" and the agency has directed labs to do so. Know how to destroy this stuff? Nuke it in a high pressure autoclave.
But I only know that this same virus turned my little kid body into a high pressure autoclave and I haven't forgotten it. Which brings to mind Kurt Vonnegut's Slaughterhouse-Five, a marvelous book that begins with the marvelous line, "Billy Pilgrim has come unstuck in time."
Fictional Billy Pilgrim, like the real Vonnegut, is an American POW who survives the horrific firebombing of Dresden. Unlike Vonnegut, Pilgrim is taken by flying saucer to Tralfamadore, a planet where it is known that past, present and future all exist at the same instant. That's how they know the universe ends during the testing of a new rocket fuel, but they can't stop it because the Tralfamadorian pilot that pressed the button that destroyed the universe has always pressed the bottom and always will.
In short, the universe ends by stupid accident, which is exactly what I expect.
