Tuesday, April 12, 2005

Cleaning the fridge of pandemic virus

What would you call it if a pandemic flu virus that killed several million people was sent to 5000 laboratories in 18 countries as part of a routine kit for quality control and certification purposes (meaning it might be handled by relatively inexperienced personnel)? How about, "major fuck-up."

The 1957 influenza A/H2N2 pandemic strain hasn't been in vaccines since 1969, so anyone under the age of 37 would likely have no immunity to it. The company apparently responsible is Meridian Bioscience Inc. of Cincinnati, Ohio who was in charge of preparing the kits for the College of American Pathologists. From their website:
Influenza A Virus- Influenza A Virus Antigen (Etiologic)
  • Lyophilized specimen for antigen detection.
  • Each lyophilized specimen is comprised of a rubber stoppered glass vial containing a freeze dried virus infected cell suspension and fitted with an aluminum crimp cap.
  • Each specimen is labeled per specifications.
It's unclear how long the vials have been at the laboratories or whether they have already been used anywhere. The last shipment was said to be in February.
“The risk is relatively low that a lab worker will get sick, but a large number of labs got it and if someone does get infected, the risk of severe illness is high and this virus has shown to be fully transmissible,” said the WHO’s influenza chief, Klaus Stohr. (The Scotsman)
CBC reports Canadians were the first to recognize the danger. Ninety-nine percent of the kits went to labs in the US, except for 20 to Canada and 61 that went to labs in 16 other countries in Europe, Asia, the Middle East and South America. WHO won't identify the other countries that received the samples. That's comforting.
The test kits are used for internal quality control checks to demonstrate that a lab is able to correctly identify viruses or as a way for labs to get certified by the College of American Pathologists.
The kits involve blind samples. The lab then has to correctly identify the pathogen in the vial in order to pass the test. Usually, the influenza virus included in these kits is one that is currently circulating, or at least one that has recently been in circulation.

On March 26, National Microbial Laboratory Canada detected the 1957 pandemic strain in a sample not connected with the test kit. After informing WHO and the CDC of the strange finding, the lab investigated. It informed the U.N. health agency on Friday that it had traced the virus to the test kit. (Emma Ross, AP, via Kansas City Star)
Thus the kit is an unlabeled "unknown" the lab is supposed to identify correctly. The company was instructed to select a virus from its inventory and they used a pandemic virus, a decision Stohr described as "unwise," and "unfortunate." That's the thing about a blog. Klaus Stohr has to say "unwise" and "unfortunate." Revere can say, "major fuck-up."

WHO is urgently calling on the labs to destroy the virus immediately and verify it has been destroyed within 24 hours. But even if these vials are destroyed, others probably exist:
Stohr said the test kits are not the only supplies of the 1957 pandemic strain sitting in laboratories around the world.

"The world really has to think what routine labs should be doing with these samples they have kept in the back of their fridges," Storh said.
With friends like these, who needs bioterrorists?

[NB this post has been amended slightly from the original.]

Update (4/13/05, 9:30 am EDST): Reuters reports this morning that some of the laboratories that received the proficiency kits outside of the US and Canada included Saudi Arabia, Jamaica, Mexico, Lebanon, Brazil, Hong Kong and Italy. WHO's Stohr is saying that these labs would have had the "approval of their governments." I doubt this could mean "specific" approval. It may merely mean government certification of the laboratory to handle specimens. Stohr says that laboratories in Canada, South Korea, Hong Kong and Singapore have already reported they destroyed the virus. He also notes that not all of the US laboratories have been identified.

Update (4/13/05, 4 pm EDST): Here is the complete list of countries that received the kits, courtesy of DemFromCT (and his excellent site that also tracks bird flu The Next Hurrah):

Bermuda, Belgium, Brazil , Chile, France, Germany, Hong Kong Special Administrative Region of China, Israel, Italy, Japan, Lebanon, Mexico, The Republic of Korea, Saudi Arabia, Singapore, Taiwan, China

WHO also has this to say:
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 obvious question: what about when proper precautions are not followed?

Source: International response to the distribution of a H2N2 influenza virus for laboratory testing: Risk considered low for laboratory workers and the public