H1N1 COUNTERMEASURES STRATEGY AND ... - PHE Home

NBSB Pandemic Influenza Working Group
Detailed Report
Dr. Jernigan: Many public health labs have multiple machines. Applied Biosystems
loans machines for limited times. But we’re limited in how we can use them. It’s not an
influenza-only platform, and we want to be able to use them. Getting more machines
requires more qualifications and also more proven protocols, which we’re working on.
We also want to improve throughput with the existing platform. With a new platform,
we can’t distribute reagents. There are limitations of FDA clearance; you could apply for
an EUA, but then you have time limits, data issues, etc.
Dr. Pavia: I read the PCR protocol. It lists five platforms for which performance has
been explored, and some of those have high throughput.
COL Harms: [There’s not enough time during an EUA.] – incomplete answer
Dr. Hojvat: We’re waiting for CDC data on lifecycle, but we’ve gone to commercial
companies to get their reagents for H1N1. That would increase clinical labs’ [capacity].
Another opportunity is the reference labs. We’re working with Quest on an EUA, and
with some others as well, to persuade them that EUA submission is not too burdensome,
and what they’ve done already in house should be 90% of the information needed to
validate.
Dr. Pavia: What would clinicians do?
Dr. Cantrill: We have a huge problem with the number of worried well coming to the
ED. Before I test, I ask how the result will affect my work. If it won’t, is there a public
health or research reason to test? If the latter is true (research), the patient should not pay
for it. If it changes what I do, what is the prevalence of disease and the sensitivity and
specificity of the test? Rapid influenza tests are worse than a coin flip. Sometimes the
information affects what I do - e.g., use of antivirals or need to test those hospitalized for
ILI per my institution protocols. All the others are educated and sent home; I’m not
going further with diagnostic tests.
We at Denver Health provided more than $200 million in uncompensated care last year.
Consider the overall costs to the health care system. Tests can be helpful in making
decisions about antivirals, but is a rapid test helpful? Or do I really need a more accurate
test?
Dr. Pavia: What’s on CDC’s wish list for surveillance and diagnosis?
CAPT Fiore: We always want more information. We participate in monitoring trends in
virus resistance and characterizing viruses. We get information from established
surveillance systems, but sometimes there are unusual infections and clusters, and we
want to get diagnostic specimens and don’t want the lack of availability or interest in
testing to keep us from getting specimens. There are limits at the local level, at academic
centers - especially during the peak when most of the cases are novel influenza. It’s still
useful for them to do a fair amount of diagnostic testing. I think they like having rapid
diagnostics for planning around isolation and further testing.
Dr. Jernigan: For bacterial infections, you test and you get the type, the antimicrobial
susceptibility, and that information is useful for management. You can send it up the
chain, and that’s useful. But influenza is the opposite. Detailed information is limited,
and there’s no commercial utility or market incentive to make the tests. If knowing the
subtype affects management, then manufacturers may have some market incentive to
make the tests. Short of that, we rely on public health and other subsidized surveillance
to monitor what’s happening.
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