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I would now like to turn the conference
over to William Koehne.
Thank you, you may begin.
Thank you Jennifer.
Good afternoon.
I'm William Koehne and I'm representing the Clinician
Outreach and Communication Activity,
COCA with the Emergency Risk Communications Branch
at the Centers for Disease Control and Prevention.
I'm delighted to welcome you
to today's COCA call Updated CDC Laboratory Testing Guidance.
You may participate in today's presentation
by audio only via webinar or you may download the slides
if you are unable to access the webinar.
The PowerPoint slide set and the webinar link can be found
on our COCA Web page at emergency.cdc.gov/coca.
Free continuing education is offered for this COCA call.
Instructions on how to earn continuing education will be
provided at the end of the call.
CDC, our planners, presenters and their spouses/partners wish
to disclose that they have no financial interest
or other relationships with the manufacturers
of commercial products, suppliers of commercial services
or commercial supporters.
Planners have reviewed the content
to ensure there is no bias.
This presentation will not include any discussion
of unlabeled use of products or products
under investigational use.
At the end of the presentation you'll have the opportunity
to ask the presenters.
On the phone dialing Star 1 will put you in the queue
for questions and you may submit questions
through the Webinar system at any time during the presentation
by selecting the Q&A tab at the top of the webinar screen
and typing in your question.
Questions are limited to clinicians who would
like information about Zika and laboratory testing.
For those with media questions please contact CDC media
relations at 404-639-3286 or send an email to media@cdc.gov.
If you are a patient please refer your questions
to your healthcare provider.
At the conclusion of today's session the participants will be
able to: describe all available food and drug administrative -
administration emergency use authorizations
for Zika virus assays; discuss Zika virus testing methods
including molecular and antibody detection; explain the role
of public health laboratories, clinicians,
and health departments and Zika virus testing;
and identify Zika virus laboratory testing algorithms
and resources.
Today's first presenter is Dr. Christy Ottendorfer.
Dr. Ottendorfer is currently serving as a team lead
of the Zika Lab Team Task Force
at CDC's Emergency Operations Center.
As a Virologist she's conducted doctoral
and postdoctoral research
on arboviruses including flaviviruses.
Prior to CDC, Dr. Ottendorfer's work experience included
laboratory positions
at the state public health reference laboratory
at the Florida Department of Health
for clinical laboratory testing and diagnosis
of arboviral diseases.
Our second presenter is Dr. Matthew J. Binnicker
with the American Society for Microbiology.
Dr. Binnicker completed a fellowship at -
in clinical microbiology at Mayo Clinic in Rochester Minnesota.
He is currently the Director of Clinical Virology
and an Associate Professor of Laboratory Medicine
and Pathology at Mayo Clinic.
Our third presenter is Dr. Grace Kubin with the Association
of Public Health Laboratories.
Dr. Kubin has been the Director
for the Texas State Public Health Laboratory since 2011.
She has been involved with multiple disease outbreaks
which required rapid increase in capacity
such as the 2001 H1N1 pandemic,
West Nile in 2012 and Ebola in 2014.
At this time please welcome Dr. Ottendorfer.
Good afternoon everyone.
My name is Christy Ottendorfer with the Centers
for Disease Control and Prevention.
And today's presentation I'll be covering the new guidance
for U.S laboratories testing for Zika virus infection.
As CDC learns more about Zika virus CDC incorporates new
information into its laboratory guidance for Zika virus
so that we can refine and improve these assays.
During this call I have included some questions here for you
to consider as a part of the new algorithms
that have been developed.
Approximately two weeks ago CDC issued an update to its guidance
for US laboratories testing for Zika virus.
This guidance expands the test parameters
for CDC's approved Trioplex RT-PCR assay as well
as acknowledging other available commercial tests.
In addition the guidance document provides additional
clarification for symptomatic patients
and asymptomatic pregnant women with epidemiological criteria
that should be tested, plus the appropriate testing algorithms.
The full algorithms are located on the website noted here
and will be covered in more detail
by another presenter today.
As you may have experienced, laboratory diagnosis
of Zika virus is complicated.
There is often cross-reactivity
with other circulating flaviviruses
or prior yellow fever vaccination history in patients.
This figure provides some background
on why different tests and specimens are needed.
Following exposure Zika virus RNA is the first detectable
analyte in the blood.
That's shown in the first curve.
Zika virus RT-PCR should be performed
for specimens collected within 14 days after onset of symptoms.
Urine and amniotic fluid can also be collected
for this type of molecular test.
As viremia declines the second detectable analyte,
anti-Zika IgM antibodies, that are shown
in the second curve, will rise.
Serology assays are used to detect Zika virus specific IgM
and neutralizing antibodies
which typically develop towards the end
of the first week of illness.
Of note IgM antibody levels also decline over time.
As a result anti-Zika IgM antibodies can be detected
up to 12 weeks after infection.
Since these analytes rise and fall over time it's important
to collect a paired serum to assist in diagnosis
as antibody levels may remain elevated
for a longer time period than the viral RNA.
Finally as a reminder testing should be limited
to specimens collected
from individuals meeting CDC's clinical
and epidemiological criteria.
There are three assays that are commonly used
to detect Zika virus, nucleic acid tests,
which are also commonly called RT-PCR assays,
are used to detect viral RNA.
In addition there are two types of serological assays,
the IgM ELISA and the plaque reduction neutralization test
or PRNT.
The Zika MAC-ELISA is used for presumptive detection
of the Zika IgM antibodies and specimens that are positive
on Zika MAC-ELISA are currently further analyzed using a plaque
reduction neutralization test;
however PRNT confirmation is not currently routinely recommended
in Puerto Rico.
And this is one of the updates to the laboratory guidance
that was recently issued.
The reason for this is there is a high prevalence
of dengue virus and cross-reactivity
in these tests in that area.
CDC developed the first two diagnostic assays for Zika virus
that FDA issued an Emergency Use Authorization.
The MAC-ELISA is used for presumptive detection
of anti-Zika IgM antibodies,
whereas CDC's Trioplex RT-PCR can detect Zika,
dengue and chikungunya viral RNA, which can distinguish
from other viruses with similar clinical signs of Zika virus.
These Trioplex test results can help inform important clinical
and public health decisions as well as improve efficiency
and throughput of laboratory testing.
CDC's Zika diagnostic assays are distributed in the United States
in the Laboratory Response Network,
and have also been distributed internationally including
over 1000 Trioplex RT-PCR kits to 115 countries.
The low level of viremia observed
in some Zika virus cases poses a challenge for molecular testing.
As a result, CDC continues to refine and improve its assays.
Recently the FDA approved the addition of whole blood
and analysis of larger sample volumes
for CDC's Trioplex assay.
These updates were demonstrated to increase the sensitivity
of the Trioplex assay and both methods may improve detection
of low levels of viral RNA.
Further, new laboratory instruments were approved
that are commonly available in diagnostic laboratories.
This is an overview of other commercial assays
that have been developed for Zika virus diagnostic testing.
There are ten commercial diagnostic manufacturers
that have received an FDA EUA
for molecular test for Zika viral RNA.
Recently all manufacturers
with EUA molecular tests were requested
to reassess individual test sensitivity using an FDA
recommended reference panel.
The FDA reference panel contains RNA
from two current Zika virus strains
and three controls for blind testing.
Test performance results of these assays will be published
so that test performance can be compared among EUA manufacturers
by laboratories nationwide.
Besides the CDC Zika MAC-ELISA one commercial diagnostic
manufacturer has received an EUA for serological test.
Similar to the FDA reference panel mentioned above,
three independent laboratories are also conducting performance
evaluation of the available serological assays.
These results will help inform future laboratory
testing decisions.
Three commercial laboratories have been licensed
and are using CDC's Zika MAC-ELISA.
This is an overview of all of the nucleic acid-based EUAs
that are approved for Zika virus testing.
Note whole blood is approved for CDC Trioplex assay only.
Please check with your laboratory prior
to specimen collection as each EUA has specific requirements
and which assays are available at that laboratory.
Specific information on each FDA EUA is available
at the website noted here and refer to the labeling section
for further instructions.
This is an overview
of the available IgM antibody test for Zika.
Further CDC is meeting with states with high risk
of local transmission.
At this time the state of Texas has identified a potential case
of local Zika virus transmission
and CDC is supporting their investigation.
Fortunately we have Dr. Kubin on the line today and she will be,
I'm sure, have a lot of lessons or a lot of discussion
of this topic and things that they're learning at this time.
In addition CDC works to ensure there is adequate laboratory
capacity for potential testing demand and providing reagents
to support the CDC developed assays for Zika virus.
In closing, CDC recently issued updated laboratory guidance
as we learn more about Zika virus infection and detection.
To improve sensitivity of the CDC Trioplex assay whole blood
and analysis of larger sample volumes were added to the EUA.
Serum must also be collected for serological testing.
FDA has approved several EUAs
for Zika virus clinical diagnostic testing as well
so not only CDC developed assays.
CDC will continue to monitor Zika virus disease
and incorporate what is learned
into its recommendations and guidance.
Thank you for your attention.
All right, so this is Matt Binnicker.
I'm the Director of Clinical Virology at Mayo Clinic
and I want to thank everyone who's calling in today
for this update on Zika virus testing.
I also want to thank APHL, ASM, who I'm representing today,
and the CDC for coordinating this important webinar
and for inviting me to participate.
So the goal for my portion of the presentation will be
to provide you with an update on the assays that are available
to clinical laboratories for the diagnosis of Zika virus.
And then we're going
to highlight how we can use these tests.
And we're going to do that by reviewing a series
of case vignettes.
I think one of the things that we've come to recognize
and appreciate since the beginning
of the Zika virus outbreak is that our success
at controlling this virus is going to require a team effort.
It's going to depend on careful coordination
and cooperation among healthcare providers, public health,
but also clinical laboratories.
And I can't stress enough that involvement of both local
and private diagnostic laboratories will be essential
in optimizing our ability
to control this emerging viral threat and diagnose
and manage our patients.
And I think this is because the local laboratories are going
to be closest to the patient, and can provide the most rapid
and actionable results.
And in addition, clinical labs must be involved
and play an integral role so that we can reduce the burden
of testing that's placed on our public health labs,
such as the CDC, during these outbreak settings.
Currently, as was reviewed during the first portion
of the presentation, diagnostic assays for Zika,
whether they be molecular or serologic,
require emergency use authorization from the Food
and Drug Administration prior to being used routinely.
The CDC assays were the first
to receive emergency use authorization,
and as was discussed, include the Trioplex PCR
and the MAC-ELISA serology test.
Trioplex detects Zika, dengue, and chikungunya viruses
from a variety of different sample types.
And according to the latest testing guidelines
that were released recently,
serum remains the preferred sample type but now whole blood
and additional sample types can be submitted.
But if they are [submitted], they should be accompanied
by a paired serum sample.
There have been some recent studies that have been published
and shown that Zika virus may be shed in sample types
such as urine and whole blood for longer periods of time.
So those samples may be a good option if it's been more
than a week or 14 days since the patient had their onset
of symptoms.
Importantly, the Trioplex PCR assay is currently available
only at the CDC and in select CDC designated public
health labs.
The MAC-ELISA assay is a serologic test,
that detects IgM class antibodies from serum samples
and at this time it is available only at the CDC but also
at CDC designated public health labs,
and also some designated reference laboratories.
Fortunately, as was reviewed earlier, there are now a number
of commercial assays
that received emergency use authorization and are available
for detection of Zika nucleic acid
or antibodies directed against the virus.
The table on this slide is similar to the one
that was shown earlier.
It summarizes some of these commercial assays
that have received EUA.
The second column of the table summarizes the method
that is used, for example, real-time RT-PCR
or transcription mediated amplification, or in the case
of the commercial assay that is approved for serologic testing,
it utilizes an IgM Capture ELISA technique.
The third column also shows the sample types
that have received EUA for each of the respective assays.
I should emphasize though that this is not going
to be an all-inclusive list
and that additional assays will likely become available
in the coming months from various commercial companies.
So now that we have a better appreciation for the assays
that are available to both public health
and clinical laboratories for the diagnosis
of Zika virus infection,
I wanted to spend some time discussing how these tests
should be used in the clinical setting.
And we're going to do that by reviewing four short
clinical cases.
So in the first case we have a 27-year-old female
who has recently returned from vacation in Jamaica.
And one week after arriving back home,
the patient takes a pregnancy test, which is positive.
However, the patient was well throughout the course
of her trip and has not had any symptoms following her return
so in her conversations with her primary care provider
and her obstetrician, the question comes up,
"Is Zika testing recommended in this patient, and if so,
what type of testing should be performed?"
Due to this patient being pregnant
and recently visiting an area
where Zika virus transmission is occurring,
diagnostic testing would be recommended in this case.
A key factor in determining which type
of testing should be performed is the amount
of time that's passed between the patient's return from travel
or their last possible exposure,
and when they present for evaluation.
So if it's been greater than 14 days since the patient returned
from travel or had their last potential exposure then
serologic testing is recommended, and that's shown
in the grayed out portion on the right-hand side
of the algorithm on this slide.
However, if it's been less than 14 days, as is the situation
in this case, then it's recommended
to test a serum sample by an EUA approved PCR method
for Zika virus.
Urine and whole blood now may also be tested,
but if they're submitted, they should be accompanied
by a paired serum sample.
So a positive PCR result in any
of these specimen types would be diagnostic
for Zika virus infection.
And that's showed again grayed out on the left-hand side.
But our patient, however, tested negative by PCR.
Now you might think that with a negative PCR result,
we'd be done with testing in this case.
But in pregnant females who test negative by PCR
and are presenting less than 14 days
after their last potential exposure, it's recommended
to collect a serum sample between that two
and 12-week timeframe after their return from travel
and that serum sample would then be tested
for IgM class antibodies.
And that's because the period of positivity by PCR is very brief,
as was highlighted with the figure earlier
on during the presentation.
In our second case we have a 45-year-old gentleman
from Honduras.
And he visits his family in Texas.
He indicates that he was well during the first seven days
of his visit but has experienced an intermittent low grade fever,
a rash, and mild joint pain over much of the past 2-1/2 weeks.
So again the question comes up,
"Is Zika testing indicated in this patient?"
So as we learned in the first case, one of the first pieces
of information that we need
to drive appropriate testing is determining the amount
of time that's passed between exposure or symptom onset.
So in this case it's been over two weeks
since the patient developed symptoms,
so the recommended approach would be
to test a serum sample by Zika IgM serology.
In addition, serologic testing for chikungunya
and dengue virus would also be indicated
since they can be circulating in that area
and cause a very similar clinical presentation.
Our patient tested positive for IgM class antibodies
to Zika virus and results
for dengue were interpreted as equivocal.
In this situation, the serum sample should be tested
by plaque reduction neutralization at CDC
or a designated lab prior to confirming the diagnosis
as Zika virus infection.
In our third case, we have a 57-year-old female
who lives in Des Moines, Iowa.
And she recently visited Haiti as part
of a church mission trip.
Two days after returning home,
the patient contacts her primary care provider, and like most
of us has seen a lot of information of Zika on the news,
and so this patient is worried and requests testing for Zika.
When asked whether the patient has been ill,
the patient responds that she was well during her trip
and remains asymptomatic but is worried about an exposure.
So in this case, is testing recommended?
The current guidelines state
that diagnostic testing is not recommended
in asymptomatic non-pregnant individuals
such as the patient in this case.
One caveat that we need to consider is blood donors
and potentially organ and/or tissue donors.
On August 26 of this year, the US Food
and Drug Administration recommended
that all blood donated in the United States be screened
for Zika virus using a molecular test.
Currently there are several screening assays available,
which use nucleic acid amplification technology.
We definitely need more data to guide testing in this area,
especially in regards to screening organ donors
that have visited or reside in the Zika endemic region.
And our final case is of a 29-year-old female
who has laboratory-confirmed Zika virus infection during the
second trimester of her first pregnancy.
And following delivery of her child, a clinical exam
of the infant is performed which reveals no evidence
of any physical abnormalities.
So in this situation where we have an infant with no evidence
of disease but that infant is born to a mother
who had lab-confirmed Zika virus infection during pregnancy,
is specific testing for Zika virus in the infant recommended?
So the answer in this case is, yes,
lab testing would be recommended and it's recommended for infants
who are born to mothers with lab evidence of Zika infection.
But in addition, testing is also indicated for infants
with findings suggestive of congenital Zika who are born
to mothers with an epidemiologic link.
For example, did the mother travel to or live
in an endemic region for Zika virus during pregnancy?
So if those characteristics or features are met,
initial testing of the infant should include Zika PCR of serum
and urine, and as well, serology testing should be performed
on the serum sample collected
from the infant using an assay detecting IgM class antibodies
to Zika virus.
The table on this slide provides a summary
of how lab results should be used and interpreted
when evaluating a patient
for possible congenital Zika virus infection.
So in the very first scenario, we have an infant
with a positive PCR result on any sample type.
And then regardless of the serology findings,
if the PCR result is positive,
this patient would be interpreted as a case
of confirmed congenital Zika virus infection.
For those infants that test negative by PCR but are positive
for IgM class antibodies by serology,
they would be considered to have probable congenital infection.
Finally, newborns testing negative by both PCR
and IgM serology, as is going to be the case in the majority
of the patients that we see,
these individuals will be interpreted as negative
for congenital Zika virus infection.
So to summarize this portion of the presentation,
Zika virus poses a significant challenge to public health
and clinical diagnostic labs.
I'd reemphasize
that a coordinated effort involving healthcare providers,
clinical labs and public health will continue to be needed
to identify cases and control the outbreak.
And finally, one thing that is certain is that this is going
to continue to be an evolving process.
We continue to learn more about the virus with each passing day
and new data are going to continue to become available
that will guide our diagnostic algorithms.
So maintaining flexibility and focusing on good communication
between the provider at the bedside and the clinical lab
and then ultimately with our colleagues
in public health will be keys to success in the future.
So with that I'm going to pass the baton on to my colleague.
Dr. Grace Kubin.
who will provide you with some guidance and information
from the perspective of the public health lab.
Hi. Good afternoon everyone
or good morning wherever you may be located.
Thanks very much to my colleagues on this webinar
for giving such an excellent overview
and discussion about Zika testing.
I also would like to thank ASM and of course APHL
who I'm representing on the call today for the opportunity
to speak about this topic.
As Dr. Ottendorfer mentioned earlier this week we announced
in Texas that we are investigating a Zika case
that was probably caused by local transmission.
So needless to say my colleagues here at the health department
and everybody at the lab have been quite busy this week
as well as a lot of our individuals
out in the local health departments spent a good deal
of their Thanksgiving holiday dealing with this too.
So I want to thank our colleagues in Florida as well
as Dr. Ottendorfer for all her help and assistance and insights
as we're trying to work through all the issues that we've seen
with this most recent case.
So I just kind of wanted to talk a little bit about some
of the parallels that we saw with Zika and that we also kind
of saw in the Ebola response.
Ebola and Zika viruses were similar
in that not much is known about them.
Zika virus was first identified in the late 1940s
but was not really seen in humans until the early 1950s.
As you know, Ebola was not well-characterized.
I think it was seen quite a bit earlier but still,
not much was really known about it.
And of course the first documented large-scale outbreak
for Zika did not occur until 2007 which was on Yap Island.
I'm sure many of you who are having to be involved
in Zika response probably have heard quite a bit
about that outbreak.
And we also really didn't know much
about how the virus performs in the body
and other characteristics such as how long it might persist
in the body and in what type of fluid, cells, or tissues.
There was also a lot of confusion regarding testing
and shipment of specimens.
So initially, most commercial
and private labs did not perform either the Ebola or Zika tests
and providers were unfamiliar with how to get specimens
to the public health laboratories
who did do that testing.
With a typical infectious disease I'm sure most
of you are aware that usually the primary care providers are
the ones who are most involved.
But with both of these diseases we saw many different healthcare
providers involved in the response.
First responders, emergency department personnel,
and individuals that were working with patients
in isolation for the Ebola response.
And for Zika OB/GYNs, neonatal personnel, and to steal a term
from my Florida colleagues the baby catchers,
so those individuals who really are involved with pregnancy
and the - what happens after they,
you know, provide, give birth.
So let's talk a little bit about the actual testing.
So you heard already on this webinar that there are many -
there are several different types of tests
that have been approved by the FDA for EUA.
Public health laboratories have a lot
of different types of test offerings.
So some labs still perform what we call the PCR
Singleplex assay.
Of course many of the labs, public health labs,
perform the Trioplex assay.
And of course as Dr. Binnicker mentioned that's only allowed
for laboratories who are part
of the Laboratory Response Network and approved by CDC.
Some of the public health labs
or commercial labs perform both RT-PCR and serology,
of which for the serology some
of the labs might perform Zika only IgM
and some also may perform chikungunya as well dengue IgM.
And of course some labs will perform all three PCR,
serology, and PRNT.
Of course needless to say these testing menus can be
quite variable.
That's why I really encourage if you're looking for testing
to check the websites for each
of the public health laboratories whether it's
at the city, county, or state level and also
for the commercial laboratories and private labs.
And also you might want to familiarize yourself
with the tests that are EUA approved.
As mentioned detailed information
about those assays can be found
on the FDA medical device EUA website.
Okay so I'm probably going to sound a little bit
like a broken record
but individual websites are an excellent source for helping
to know how much specimen to collect, how it should be stored
if not sent right away, and under what type
of conditions it should be sent whether it be either cold
or frozen.
You know, really the type of testing, what type of specimens
that you are collecting and how you should ship them are really
critical to ensuring that we're able to perform the tests
that are needed for the patient.
In addition our laboratory
and many other labs are collecting additional
information beyond the symptoms and the symptom onset date.
This includes pregnancy status and at what point the patient is
in during her pregnancy when she is getting testing
or maybe has been exposed, the patient's travel history,
f course this is not necessarily an unfamiliar territory
as we had to do this with Ebola,
ut then we're also looking to have the travel history
of any sexual partners.
This information really is being used to determine at least
in our health department
as to what is the most appropriate testing
for the patient.
Our epidemiologists spend a large amount of time, you know,
having familiarized themselves with the algorithms and all
of this extra information that we're collecting
to really ensure that we in the lab are doing the tests
that are most appropriate for that patient.
In addition this information is also required if we end
up having to submit specimens to CDC for additional testing.
So as mentioned previously serum is
of course the preferred specimen type for RT-PCR.
But depending on which type of test is being performed
in the lab that you might be using or working
with either whole blood, urine, or CSF could be submitted.
But I will say that all three of these types
of specimens will require a paired serum.
So, you know, if you're going to be sending us the urine,
whole blood or CSF please also send a paired serum with that.
For this test, for RT-PCR a positive result is considered
conclusive so really no additional testing is required.
Under normal circumstances and what I kind of mean
by that is not in the middle
of a local transmission investigation
and of course taking into account the lab's capacity,
PCR results could possibly be available two to three days
from the time the specimen arrives in the laboratory.
And of course this is a conservative estimate
and it could be really a shorter
or longer time really depending upon the lab's capacity
and availability for testing.
So for serology specifically the MAC-ELISA serum
of course is the only specimen type.
The MAC-ELISA really is a multi-day test
and results may be available three to four days
after arrival in the lab.
Again that's kind of a conservative estimate based
on capacity of the lab.
And this test is of course used by most
of the public health laboratories and as mentioned,
you know, any positive or clinical results
for Zika IgM will require confirmation by the PRNT.
And of course depending upon
where the patient may have been infected we will usually perform
also dengue and chikungunya serology.
So for PRNT of course, you know, again,
serum is the preferred specimen.
And only CDC or CDC approved labs will perform this test.
Really the results of the PRNT must be interpreted
in the context of the serology results again
which probably should include either a dengue
or chikungunya IgM result depending upon
where the patient might have been infected.
This test really requires more time for completion
because the basis for interpretation is whether
or not neutralizing antibodies that are specific to Zika
or the other flaviviruses probably either West Nile
or dengue or chikungunya are present
and will basically inhibit virus growth.
This virus must have an opportunity to grow
so that means it's going to take a little bit of time
for the test to be completed.
This is of course a really gross simplification
of what the assay is but hopefully I was able to kind
of at least let you all know that this is some
of the reason why it can take quite some time
for the results to come back.
Of course there are other factors
that could delay the results.
We, in our lab, pretty much only ship
to CDC Monday through Thursday.
So if we get a result on Friday it's got to wait
until probably Monday for us to ship it out.
So that can delay a couple of days right there.
So and also it will depend upon, you know, what's going on at CDC
if they've had a large influx of requests for PRNT.
They've actually done an excellent job of being able
to prioritize these samples and getting them
out really quickly as fast as they can.
But, you know, don't be surprised
if it might take a couple of weeks for you
to get these particular test results back.
And so if you think about well I submitted my sample
at the beginning of November you may not see something
until closer to the end of November if we had to go
through during both PCR - all three, PCR serology and PRNT.
So keep in mind that that just adds a lot more time
onto the actual testing time.
So I'd also like to talk a little bit about some
of our partners that we've hooked up with not only
at the public health level but also
at the health department level.
And of course many of these when I talk
about public health labs I'm talking about state,
I'm talking about local maybe county health departments also
are intimately involved in a lot of this.
We've actually been pretty fortunate to have some
of our private labs contact us and let us know
that they've brought up RT-PCR testing capacity
and have offered to assist us with testing
if our lab becomes a little bit overwhelmed for testing.
We're actually pretty fortunate in Texas
because we have multiple CDC Laboratory Response
Network labs.
We have actually ten including ours.
And they all are doing some sort or form of Zika testing.
So we have some - we're pretty lucky
that we have some actual built in capacity.
And one thing that we did do this week
as we were receiving uro specimens uro survey specimens
in is we actually kind of divided it up some
of the specimen load and we were able to ship samples to some
of these other laboratories so that we could kind
of basically get the results back maybe a little bit faster.
In addition we've actually been in contact
with several commercial labs and they are working with a lot
of their public health laboratories in their states
and cities to be ready to provide surge capacity testing
in case there is something like what happened,
a large-scale investigation.
But what was very helpful about these laboratories
and I think Dr. Binnicker mentioned this
in his presentation is that, you know,
these labs can provide the ability to collect specimens
in maybe some of the lower population areas
where resources may be very limited for obtaining testing.
You know, we see a lot of these commercial labs they do have
basically draw stations in some of our smaller communities
so it really it is helpful to have them available to kind
of work with us and also be a surge capacity for us
in the event that we might need them.
And I guess we also have several military bases in the state
of Texas who have also implemented both Zika RT-PCR
and IgM testing.
And, you know, they stand of course ready to assist us
and provide surge capacity in case we might need it.
And of course, you know, CDC is the main provider
for PRNT in the states.
But they also have a separate lab that's been set up to help
with specifically with local transmission and investigations.
So I just want to spend a little bit of time last thing
on talking about the efforts related to education
and outreach for Zika virus and response activities associated
with cases that we've had.
We had a large media campaign,
and other states are doing this too,
where public service announcements maybe on radio
or TV maybe in multiple languages and have really tried
to use social media sites to really allow us
to reach a much broader audience.
Many health departments whether they're state or local
or county are working with local healthcare personnel.
Many of the epidemiologists in these health departments,
you know, they work for closely with providers
and they actually have a lot of interactions with them.
And of course at the state level one of the things
that we've tried to do is have meetings and webinars
with a variety of healthcare provider associations.
And some of those in our state
of course are Texas State Medical Association,
Pediatric Society that we have here,
also the OB/GYN Association that we have here
and our Texas Hospital Association.
We have developed really good relationships with all
of these different groups.
And we've had the opportunity to meet with them
on several occasions and also been invited to speak at some
of their regular meetings.
We also used WIC, which is the Women's Infants and Children,
sites for distribution of pamphlets
and posting education materials.
This has been very useful for us.
We've also had the opportunity,
our state Medicaid group has been really very good
about getting out information to providers
who are Medicaid providers.
And, you know, we do have several things
and I don't actually have this in my presentation
of lessons learned about what's been occurring this week.
You know, what we found is that our local health departments,
you know, their staff, their epidemiologists, you know,
they've been working these cases now for many months
in some cases almost a year.
And they really know how to interact with their providers.
They've been invaluable in ensuring
that if a provider has a question they're really kind
of Johnny on the spot with information about how
to collect, what to collect,
what types of forms should be filled out
and also some assistance
in how they should be shipping the specimens.
I think their ability to really interact
on a very intimate level with the providers has helped us
at the public health labs be really successful
in getting specimens here to us in a manner
by which we can test them.
And, you know, so I really want to say that, you know,
this has really been, this response and what's been going
on with Zika has really been an all-hands response.
laboratories, epidemiologists, all the different types
of providers and providers that we're really not used to working
with at the public health labs because they're not used
to sending us these types of clinical specimens
because they might use a private or commercial lab.
So I think all of these individuals working together has
really been and Dr. Binnicker mentioned this too a real -
it's a team effort to make sure
that we're getting the testing done.
I think as we move forward
in the long term one thing we will have to look at is,
you know, how will we be treating Zika in the future?
So I think with all of the testing
that we're doing the additional data that's being collected
that will help guide us in where we need to go with that.
So anyway I want to thank everybody
for joining the call today and thanks for your attention.
With that I'll turn it back over to Will Koehne.
Thank you.
Thank you presenters for providing our audience
with a wealth of information.
We're now going to open up the lines
for a question and answer session.
Questions are limited to clinicians who would
like information related to Zika virus testing and laboratories.
For those who have media questions please contact CDC
Media Relations at 404-639-3286
or send an email to media@cdc.gov.
If you are patient please refer your questions
to your healthcare provider.
When asking questions please state your organization
and also remember that you can submit questions
through the webinar system.
Operator if you'd like to open up the phone lines,
we have a few webinar questions that I'd like to go
through before we get to the phone Q&A.
But, the first one is from Mary Anderson.
She's asking, 'When submitting
for whole blood testing what is the preferred anticoagulant?"
And she is also asking for a specific tube collar.
Hi. This is Grace Kubin.
I'll be happy to answer that information.
So when you're submitting whole blood for the basically
for the Trioplex assay it is a purple top tube with EDTA.
All right thank you Grace.
We have another one from Southern Sumason asking,
"What is the appropriate time window
to test an infant with suspected Zika?"
So would - I know Matt Binnicker,
Dr. Binnicker presented on that.
Would you like to elaborate a little bit on that?
Yes. I believe it's within the first two days
of life is what's listed on the CDC website but I want
to make sure that Dr. Ottendorfer for confirms that.
I would concur with the two days.
There is some in the algorithm that if there's a possibility
that they could be screened at 18 months if,
to ensure the maternal antibodies have declined.
So there's a possibility they could be detecting maternal
antibodies and not the infant's and so they would need
to be screened at a later point.
And I'd refer back to the algorithm.
I would like to note here
that there's been a recent study that's been released
about microcephaly that wasn't, or brain abnormalities,
that weren't detected at birth
but they were detected six monrto a year
up to a year later.
And so as we learn more about this type of, you know,
new clinical manifestation I guess there may be updated
guidance on how to test infants going forward.
Thank you.
Operator do we want to -
can we take a question from the phone lines?
Thank you.
We'll now begin the question and answer session
at this time over the phone.
If you would like to ask a question please press Star 1,
unmute your phone and record your name clearly.
When you ask your question please announce
your organization.
Your name is required to introduce your question.
If you need to withdraw that question press Star 2.
Again to ask a question please press Star 1.
The first question comes from Frederick Walters.
Your line is open sir.
So hi. I had a question in regards
to the CC MAC-ELISA test.
Have you guys seen any trends with inconclusive results
because we have certain samples that the result is inconclusive.
And we'll re-collect two to four weeks later
that it will come back inconclusive again.
Have you guys seen anything like that?
So from CDC we're actually in the Emergency Operations Center.
I would defer that question for a follow-up
with our actual laboratory teams either
in Fort Collins or here in Atlanta.
We are looking at the test results to see sort
of the person at the do confirm and we'll be happy to share
that information with you if we have your contact information.
And this is Will Koehne, William Koehne with CDC as well.
If you'd like to if there's any questions that we're unable
to answer on the call today or that we're unable to get
to please feel free to send them
to coca@cdc.gov that's C-O-C-A@cdc.G-O-V
and we'll forward that on to the correct parties
and get you an answer.
Okay thank you.
Are any other speakers or would you
like to address that question?
Okay operator are there any other questions
on the phone line?
There are.
The next question comes from I believe it was Ana Disamuels.
Your line is open.
Hi. Good afternoon.
We're logging in from Johns Hopkins Pediatrics.
Our question is regarding negative testing
in an infant whose mother had confirmed Zika virus
during pregnancy.
The infant in this case would have -
does have abnormalities consistent
with congenital Zika syndrome without any other explanations.
However the testing both PCR and serologies are negative.
Our concern is that if the infection
in the mother occurred during the first trimester
that negative serologies may not exclude congenital infection.
Are there any other thoughts about the interpretation
of negative serology in this type of situation?
That is an excellent question.
And we may defer this to our pregnancy
and birth defects groups that handles more
of the trimester and, you know, those results
and how you should interpret these assays.
Like we've mentioned the timing is critical
when those specimens are collected.
I'm not sure how old the infant was upon -
has it had follow-up testing
or it was just tested at the two day point?
Just at the newborn time period.
However the serologies were repeated
as they were initially inconclusive
so repeat sampling was sent from the serum again.
That ended up being negative.
I think this is something
that for this particular case we might try to get you in contact
with our pregnancy and birth defects team to try
to help you understand if there is another potential cause
or how to follow up with this patient.
Thank you.
The next question on the phone line comes from Dr. Hudson.
Your line is open sir.
Thank you.
This is Warner Hudson from UCLA.
I'm in charge of occupation employee health here
for the health system on campus.
We have a lot of travelers coming back from Zika areas,
researchers in Zika area,
and live Zika research work in our labs.
And most of the UC-wide Doc Med medical writers have been
working on developing post-exposure protocols
for the labs.
And of course we're doing testing for the travelers
that come back with questions or symptoms.
And at UCLA we're using the Viracore test
but the PCR tests and the IgM tests.
Does CDC have a plan
to put together post-exposure guidelines for lab workers,
even blood-borne exposures
to viremic Zika patients in the works?
Thanks. That is another excellent question.
I know that this guidance
that was released predominantly focuses
on symptomatic individuals as well as, you know,
pregnant women that, you know, those that are highest risk for,
you know, complications from Zika infection for the infants.
So I'm not sure if there is guidance planned for, you know,
more of the occupational exposure risks that may occur
in otherwise, you know, healthy adults
but we will certainly take that into consideration
and bring it back to the leadership as a request.
Alright thank you.
So we have a question from the Webinar system
that I'd like to ask quick.
We have - the question is we have encountered several mothers
with history who travel to Zika endemic areas longer
than 12 weeks ago.
Testing has been negative.
Newborns are healthy at birth.
What - they're asking what role of IgG
to document earlier exposure to the virus?
What is the role of IgG
to document earlier exposure to the virus?
So I guess I'll take this one too.
As far as IgG we don't have a specific assay for IgG,
the plaque reduction neutralization test
for once the neutralizing antibodies develop
which in my slide I didn't show that part of the course
of illness or your, you know, your antibody response.
But at some point in that window IgG begins
to rise longer than 12 weeks.
And so if you were to have
that sample tested it would probably be tested
in plaque reduction neutralization
and it could be possible
to detect a infection in that sample.
But I would defer to Grace or anyone else
that has more experience
with samples collected after 12 weeks.
Hi. This is Grace Kubin.
We don't we haven't really typically tested
or have been sent very many samples after 12 weeks.
I do know a few labs that have but they don't -
some have seen a positive and some haven't so, you know,
it's basically just a byproduct
of how good a person's immune system is.
Right and I would agree.
I mean if we're testing the infant here you'll have maternal
antibodies until about 18 months so it could be confounded
by the mother's antibodies or IgG at that point.
So you would want to retest if you have either clinical
or epidemiological criteria for this infant at 18 months.
All right thank you presenters.
I think that's all the time that we have for questions today.
And on behalf of COCA we would like to thank everyone
for joining us today with a special thank you
to our presenters Drs.
Ottendorfer, Binnicker and Kubin.
And please feel free to contact the presenters after the call
by emailing COCA at cdc.gov that's C-O-C-A@cdc.G-O-V.
The recording of this call and the transcript will be posted
to the COCA website at emergency.cdc.gov/coca
within the next few days.
We have two upcoming COCA calls next week.
On Tuesday, December 6 at 2:00 PM Eastern Time please make sure
to join us for "Risk Mitigation Strategies
to Reduce Opioid Overdoses," part of a COCA call series
about the CDC Guideline
for Prescribing Opioids for Chronic Pain.
In addition, please join us next week Thursday,
December 8 at 2:00 PM Eastern time
for another COCA call on Zika.
This one is called "Gearing Up for the Travel Season,
How Clinicians Can Ensure their Patients are Packed
with Knowledge on Zika Prevention."
And we have speakers from CDC pregnancy and birth defects
and CDC Zika Travelers Health presenting for that call.
All continuing education for the COCA calls are issued
through the TCEO online the CDC Training
and Continuing Education system at www.cdc.gov/tceonline.
Those who have participated in today's COCA call and would
like to receive continuing education should complete the
online evaluation by December 31,
2016 and use the course code WC2286.
Those who would - who will review the call on demand
and would like to receive continuing education should
complete the online evaluation between January 1,
2016 and November 30, 2018
and they will use the course code WD2286.
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Thank you again everyone for being part of today's COCA call.
Have a great day.
That concludes today's conference.
Thank you for your participation.
You may disconnect at this time.
Speakers please stand by for your post conference.
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