CEO SUMMARY: As influenza A/H1N1 spread, clinical labs nationwide learned that they did not have the capacity to test for an outbreak of flu that generated a 10-fold increase in sample volume. To move the samples through the system, many clinical labs ran extra shifts and ran short of supplies. It was a similar situation at public health laboratories, which were inundated with influenza specimens and sometimes a week behind in reporting results. In turn, that meant health officials were often days behind tracking the flu outbreak.
EVERY PANDEMIC OFFERS LESSONS for health professionals seeking to prevent or limit the next event. The current A/H1N1 influenza pandemic has been no exception.
In the United States, the recent A/H1N1 flu outbreak revealed at least four major lessons for lab directors and pathologists. First, the nation’s capacity for running confirmatory tests on a new strain of disease, such as A/H1N1, was severely limited. Second, clinical laboratories didn’t have the supplies they needed to meet a sudden, 10-fold increase in testing volume for a new infectious disease.
Third, public health labs also lacked the supplies and the capacity to meet this same surge in specimens requiring confirmatory testing. Fourth, the A/H1N1 outbreak demonstrated that molecular testing is now an effective and relatively fast way to detect and identify a specific strain of virus. Rapid molecular assays give public health officials useful new tools to identify and characterize the spread of a virus like A/H1N1.
Experts point out that one important fact about the recent A/H1N1 outbreak is that it began in April, at the very end of the normal flu season in the Northern Hemisphere. Thus, public health agencies in the United States and around the world faced a much reduced incidence of flu cases compared to what would be expected during the height of the normal flu season, which usually peaks in January or February.
These experts also predict that A/H1N1 will be around next flu season. Jeremy Bridge-Cook, Ph.D., Vice President of Luminex Molecular Diagnostics, in Toronto, Canada, said current testing shows poor immunity worldwide for A/H1N1. Luminex developed the xTAG Respiratory Viral Panel, which tests for 12 different respiratory viruses including influenza A and the normal season flu subtypes H1 and H3.
Poor Immunity in Population
“It’s impossible to predict what we will see during next winter’s flu season,” observed Bridge-Cook. “However, in the United States now, of the samples that test positive for influenza A, roughly 50% are actually the new H1N1 strain. It suggests that the population has poor immunity. In turn, that does not bode well for the coming flu season. This recent H1N1 pandemic hit during a relatively quiet part of the influenza season.”
Steven B. Kleiboeker, DVM, Ph.D., is Chief Scientific Officer and a Vice-President of ViraCor Laboratories in Lee’s Summit, Missouri. He agreed, saying, “Laboratories in the United States experienced a phenomenal surge in specimen volume during the first few weeks of the outbreak of A/H1N1. This event shows that the capacity in our nation’s public health system for large amounts of testing is inadequate.
“For example, case volume for the primary assay we run for influenza increased 10-fold,” continued Kleiboeker. “That increase lasted only about two weeks. But to accommodate that volume, we extended our normal testing operations by about five or six hours each day. We generally run our lab at about 60% or 70% capacity on any given day. The resources of our laboratory were definitely strained when case volume for one assay in our test menu surged by a factor of 10.
“At ViraCor, we specialize in testing for immuno-compromised patients, which are usually transplant patients,” Kleiboeker said. “Most of our clients are hospital laboratories. Only one client sent us a lot of specimens. This client is located in the Southwest, in the border region where the earliest and most rapid spread of the virus was expected to occur. If two, three, or four clients had sent us comparable volumes of flu specimens, our lab would have been challenged to accommodate this testing and sustain normal turnaround times.”
Stories of public health labs being inundated with influenza specimens were common, said Kleiboeker. “One thing we learned about A/H1N1 was that the ability of the public health community and public health laboratories to step in and accept such a surge in testing volume was woefully inadequate,” he observed.
“We heard stories that, given the heavy demand, some state public health labs were 4,000 to 6,000 samples behind per day,” said Kleiboeker. “In the early stages of an epidemic, the pathogen is often spreading rapidly and if laboratory testing can’t keep up with demand, then health officials don’t know where the virus has spread until two or three days later. In these situations, having an accurate and confirmatory diagnosis of the case from a timely lab test is critical.”
Delay In Test Confirmations
In Houston, Texas, by May 12, its public health laboratory had received 6,387 specimens from 17 counties in Texas and only 2,334 had been tested. That left a backlog of 4,053 untested influenza specimens, according to television station KPRC in Houston. KPRC also reported that the public health lab had confirmed 52 specimens as positive for A/H1N1. One pathologist interviewed by the television station said that his hospital was waiting for results on flu specimens his laboratory had referred to the city’s public health lab more than 10 days earlier.
On the following pages, THE DARK REPORT provides additional intelligence briefings about the influenza outbreak and how both clinical labs and public health laboratories coped with the surge in demand for influenza testing.
Expectations are that A/H1N1 will reappear during the next influenza season. That means every clinical laboratory should be developing a strategy and contingency plans to deal with different scenarios. To date, the A/H1N1 influenza has not been as lethal as initially feared by public health officials. However, because knowledge about this new strain of influenza is limited, experts remain concerned that, during the next flu season, A/H1N1 might turn out to be more virulent than expected. That is why THE DARK REPORT advises that lab managers take steps now to prepare for the coming influenza season.
Labs Report 10-Fold Surge in Test Volume As Lab Supply Chain Overwhelmed by Demand
Testing volume for A/H1N1 influenza cases rose so sharply since April that some labs saw increases of two-to 10-fold in testing volume for the novel strain and ran short of supplies.
The virology department at PAML, a medical reference laboratory in Spokane, Washington, reported a 260% increase in testing in the two weeks from April 26 through May 10 compared with H1N1 testing levels for the same period in 2008, said Mona Veltri, Director, Supply Chain Management and Administration. PAML has five joint ventures with 182 patient service centers in nine states.
Sunrise Medical Laboratories in Hauppauge, New York, reported a 10-fold increase over normal levels of H1N1 testing for April and May, said Larry Siedlick, president and CEO. On Thursday, May 14, when New York City Mayor Michael Bloomberg announced the closing of three city schools, Siedlick saw the number of flu cases rise again.
The H1N1 flu strain was detected in April in Mexico. On June 1, the federal Centers for Disease Control and Prevention (CDC) in Atlanta reported 10,053 cases in 50 states and the District of Columbia and 17 deaths. Recently, the World Health Organization (WHO) said 62 countries reported 17,410 cases of A/H1N1 and 115 deaths.
“We had problems just trying to keep supplies in stock and getting stock on a timely basis,” said Veltri. “We would put in an order and be told it would arrive on a particular day and then it wouldn’t show because our suppliers didn’t have the product. But it wasn’t just the distributors; it was the manufacturers as well. Following our disaster preparedness plan, we had conference calls to make sure we updated all the warehouses of our joint venture partners on a daily basis. When product didn’t arrive as scheduled, we filled orders short to ensure customer service to all.
“In particular, we had shortages of flocked swabs,” she said. “When we couldn’t obtain enough product for the kits, we had to use substitutions. Back up plans are critical.
“Even though there were challenges obtaining the volume of supplies we wanted, our patients were not impacted,” Veltri said. “We wanted to make sure that every client received some product. Right now, we’re fine and the testing volume seems to have slowed down.
“But what we learned was that our plan could use some modifications,” she added. “You have your contingency plan A and your contingency plan B for back up— but when the manufacturers can’t meet the demand, you know it’s a serious problem. Moreover, we all need to be on high alert. This episode shows why it’s necessary to plan and prepare for a pandemic.
“Using this experience, we are discussing ways that we can revise disaster preparedness plans,” Veltri commented. “We will meet with our distributors and field staff because we hope to be more prepared for the next influenza season for the event that may arise this fall.”