Added by Kristen Nichols Heitman • Updated Feb 28, 2019 at 10:15 PM

SFR position statement 02/28/2019

Hi all,

Attached is an updated SFR position statement draft. Please pay close attention to the following changes to the laboratory criteria for confirmed cases:

Detection of SFGR, including R. rickettsii, nucleic acid in a clinical specimen via amplification of a Rickettsia genus- or species-specific target by polymerase chain reaction (PCR) assays, or

I've included these as tracked changes in the attached position statement draft. These changes were made based on trying to not exclude future diagnostic methods (such as RNA testing), as well as to allow cases who have positive pan-Rickettsia PCR results to meet the confirmed case classification. I also caught a couple other typos.

The position statement is due March 7 (next week!). What next steps do we want to do? At the very least, I say we all review one more time before submitting. Does anyone feel the need to have a call or share with the larger working group again?

Thanks,
Kristen

Position Statement 2019_SFR_FINAL_02202019_knh02282019.docx 149 KB • Download

Comments & Events

Abelardo Moncayo

Thanks Kristen!

I don't think that we need to have a call with any other group. All our T's have been crossed but let me know if you want us to set one up. I was thinking of sharing this with the ID committee so they are aware but I think we should be good to submit. Someone from CSTE is going to advise me about the tables at the end. I'll let you all know if they recommend any changes there.

Thanks for the updates on the document. I have a question on page 5 about the edit of 1:128. Since this is about lab criteria for reporting, should it just be elevated IgG rather than specifying a titer?

Thanks,

Abelardo

Feb 28, 2019 at 10:40 PM Notified 9 people

Kristen Nichols Heitman

That's a good question! I just edited it based on what was already in there, but I do believe we decided to change it to only say "elevated IgG". Feel free to correct! Thanks!

Did anyone else find anything else to change?

Mar 04, 2019 at 6:22 PM Notified 9 people

Abelardo Moncayo

Position statements at CSTE got back to me last night with these comments and this attachment. Please let me know if you have opinions about any of this. - Abelardo

Abelardo,

My colleague Brooke and I have reviewed your position statement. Great job! Our main question is related to Section VI for case ascertainment regarding lab criteria for reporting. Is one/any of those listed positive lab results SUFFICIENT for reporting to public health, or must clinical illness be present to report those lab findings to public health? The answer to that will dictate how we proceed with additional suggested edits to Section VI and Table VI.

Attached you will find our edits in tracked changes and margin comments. I am unavailable tomorrow, but I have time on Wednesday, 3/6 for a phone chat.

I look forward to your response re: lab criteria for reporting and potentially chatting with you on Wednesday.

Best,

Meredith

Position Statement 2019_SFR_FINAL_MLCBB.docx 158 KB • Download

Mar 05, 2019 at 3:21 PM Notified 9 people

hayley.yaglom@azdhs.gov

Hi everyone.

I haven’t read the track changes in the document yet, but in reading the email below, I absolutely think that some of the laboratory criteria are sufficient to report to public health. This links me back to my original question about whether “public health” is defined as the state health departments or CDC. My interpretation is that it’s the state health departments and therefore for the majority of states, any positive laboratory results would be reported. Does everyone agree?

Hayley

Mar 06, 2019 at 2:06 PM Notified 9 people

Abelardo Moncayo

I think yes, that is the way the position statement group is interpreting it. I think this means that the 2010 position statement tables were incorrect.

Here is what I think we should accept from Meredith's changes:

Position Statement 2019_SFR_FINAL_AM.docx 158 KB • Download

Mar 06, 2019 at 3:01 PM Notified 9 people

Kristen Nichols Heitman

Separate item: I don't know if I agree with moving

A clinically compatible case where serologic evidence laboratory results report a stable IgG-specific antibody titer reactive with SFGR, including R. rickettsii, antigen by IFA between paired serum specimens (i.e., 1:256 for first serology specimen and 1:256 for second serology specimen), should be classified as a probable SFR case.

to the case classification section. This was written more for providing as an example of how to interpret laboratory results and provide more information. What do you guys think?

Abelardo, can you provide a final clean copy for review before submitting tomorrow?

Mar 06, 2019 at 3:43 PM Notified 9 people

Abelardo Moncayo

Hi Kristen,

I am working on a clean copy now. Where do you think that statement should go? Couple options: (1) an asterisk footnote in A4 Case classification under probable, or (2) a bullet under presumptive lab criteria.

Abelardo

Mar 06, 2019 at 3:58 PM Notified 9 people

hayley.yaglom@azdhs.gov

I think it is a good example, but agree with you Kristen. I am not sure we need to include as a classification.
We could modify presumptive laboratory criteria to state:
"Has serologic evidence of single elevated IgG antibody titer in a sample taken within 60 days of illness onset OR a stable IgG-specific antibody titer between paired serum specimens of ≥1:128 reactive with SFGR, including R. rickettsii, antigen by IFA reactive with SFGR, including R. rickettsii, antigen by IFA."

These would both meet probable case definition.

P.S. I don't like the order of my wording above, but something to consider.

Hayley

Mar 06, 2019 at 3:59 PM Notified 9 people

hayley.yaglom@azdhs.gov

bullet under presumptive lab criteria, just sent another message.

Mar 06, 2019 at 3:59 PM Notified 9 people

Sally Slavinski

Hi everyone - sorry to have been absent while you all were finalizing the details on this. As such, you all are free to ignore my comments as I am sure my questions have already been discussed and better that you focus on keeping things moving forward for submission.
1. I thought the lab reporting was to inform diagnostic labs what to report to public health. If that is the case, do we need to be so specific about the timing of specimen collection and titer increases for serologic testing? I don't know much about a labs ability to refine what they send and don't send but based on our experience with Zika, they are not very good with details. Is it better to just ask for any and all IgG positive specimens?

2. I am still not comfortable counting this as a probable case.

A clinically compatible case where serologic evidence laboratory results report a stable IgG-specific antibody titer reactive with SFGR, including R. rickettsii, antigen by IFA between paired serum specimens (i.e., 1:256 for first serology specimen and 1:256 for second serology specimen), should be classified as a probable SFR case.

If we are using the 4 fold change under strictly timed parameters for collection to confirm the case, why can't we use it to refute a case given a fairly non-specific clinical criteria and our argument that there is a lot of low level or old titers

Mar 06, 2019 at 5:14 PM Notified 9 people

Sally Slavinski

Also, if this is going to be added, would not sure the word stable. Instead should be more clear, “no four fold or more change’, or “no change or less than a four fold change”.

Sally Slavinski DVM, MPH, Dipl ACVPM
New York City Department of Health and Mental Hygiene
Assistant Director Zoonotic, Influenza and Vector-borne Disease Unit
Bureau of Communicable Disease
2 Gotham Center, CN# 22A
42‐09 28th Street
Queens, New York 11101‐4132
ph (347) 396 2672
fax (347) 396 2753
cell 646-872-2340

Mar 06, 2019 at 5:19 PM Notified 9 people

Abelardo Moncayo

Here is a clean copy. I updated all the tables including table IX to reflect all the changes. Please let me know what you think. I think it is almost ready to be submitted but would appreciate everyone taking a final look.

Thanks!

Position Statement 2019_SFR_CoreGroup_Clean.docx 151 KB • Download

Mar 06, 2019 at 5:35 PM Notified 9 people

Abelardo Moncayo

Sally,

I like your wording for stable. Let me see what others say. As far as your comments on reporting, take a look at the clean version table VI and page 5. I thought about deleting the four fold reporting criteria but left it in thinking that it might nudge physicians to get another sample (wishful thinking I know).

Abelardo

Mar 06, 2019 at 5:40 PM Notified 9 people

Kristen Nichols Heitman

I still think this should be a footnote for A4 and not a bullet under "Presumptive laboratory evidence" since one of the titers must be ≥1:128, which would meet the criteria listed in the first bullet.

However, if we keep it, I agree with Sally about the wording. I propose something similar to the following:
"Paired serum specimens without evidence of fourfold change, but with at least one single titer ≥1:128, in IgG-specific antibody titers reactive with SFGR, including R. rickettsii, antigen by IFA ."

Feel free to wordsmith.

Mar 06, 2019 at 6:06 PM Notified 9 people

Abelardo Moncayo

All - here is the final position statement I am about to submit within the next hour. Let me know if you catch anything you think should be changed. Thanks everyone for your contributions. We did it!

Position Statement 2019_spotted fever rickettsiosis.docx 151 KB • Download

Mar 07, 2019 at 4:00 PM Notified 9 people

Sally Slavinski

Yay! Strong work!!

Sally Slavinski DVM, MPH, Dipl ACVPM
New York City Department of Health and Mental Hygiene
Assistant Director Zoonotic, Influenza and Vector-borne Disease Unit
Bureau of Communicable Disease
2 Gotham Center, CN# 22A
42‐09 28th Street
Queens, New York 11101‐4132
ph (347) 396 2672
fax (347) 396 2753
cell 646-872-2340

Mar 07, 2019 at 8:45 PM Notified 9 people

Abelardo Moncayo

Hi all - I am presenting today on the CSTE position statement discussion webinar. Here are the materials that will be presented. I found one error. Just making sure you all agree this is an error. On slide 15 I summarize the case classifications as they are described in this final document. It says that under the suspect case definition:

Suspect:

•A case with laboratory evidence of infection and either no clinical information available or not clinically compatible, OR

•A clinically compatible case (meets clinical criteria) that has supportive laboratory evidence.

I believe the highlighted phrase should be removed since not being clinically compatible would make it not a case. Does anyone disagree?

Thanks,
Abelardo

19-ID-07_Spotted Fever Rickettsiosis_NationalOfficeReviewed_EBApproved_Reconciliation.docx 147 KB • Download

CSTE Position Statement Discussion May 13_2019.pptx 5.97 MB • Download

May 13, 2019 at 3:31 PM Notified 9 people

hayley.yaglom@azdhs.gov

Hi all,

I am curious to hear what others think, because we currently use the suspect case definition in Arizona to sort of keep track of some cases that have a relatively decent titer (e.g 256), but do not meet clinical criteria (e.g. fever of 99 only).

I would like to standardize what we do in Arizona, especially since our work with the tribes is improving and surveillance procedures are significantly strengthened.

In summary, I do then agree that if clinical information IS available and public health can determine it does not meet anything related to RMSF, then I think it would not be a case.

Also, I will be on the call today. I am presenting the plague PS.

Hayley

Hayley D. Yaglom, MS, MPH

Senior Vector-borne & Zoonotic Disease Epidemiologist | RMSF Epidemiologist

Office of Infectious Disease Services | Bureau of Epidemiology & Disease Control

Arizona Department of Health Services

150 North 18th Avenue, Suite 140, Phoenix, Arizona 85007

Cell 602-739-3553

Main 602-364-3676

Fax 602-364-3199

Email Hayley.Yaglom@azdhs.gov

Health and Wellness for all Arizonans

May 13, 2019 at 3:38 PM Notified 9 people

Naomi Drexler

Hello everyone,
Kristen is a little under the weather, so I will go ahead and respond. I believe we want to keep this phrasing in here. As far as I remember, the suspect case classification should cover three holes in the confirmed/probable case definition:
1. cases that do not list clinical information, but meet confirmatory or presumptive laboratory criteria
2. cases that list clinical information, but the clinical information does not meet the clinical criteria (maybe only fever is listed) , but either confirmatory or presumptive laboratory criteria are present
3. cases that are clinically compatible, but only offer supportive laboratory evidence.

Please let me know if this doesn't make sense, or if you think it is unnecessary. This should be consistent with that classification table (VII).
Thanks,
Naomi

May 13, 2019 at 4:17 PM Notified 9 people

Abelardo Moncayo

Hi Naomi,

So what would be not a case? I think if it is not clinically compatible, then it is not a case, even if they have confirmatory lab evidence, right?

Abelardo

May 13, 2019 at 4:25 PM Notified 9 people

hayley.yaglom@azdhs.gov

Not a case is a negative laboratory test.

May 13, 2019 at 4:33 PM Notified 9 people

Abelardo Moncayo

I think AZ is the only state that gets negative lab results. We would not know about negative labs. Would you two have time to talk on the phone before the call?

May 13, 2019 at 4:49 PM Notified 9 people

Kristen Nichols Heitman

Hi all,

Sorry, I’m late to the party! I agree with Naomi. I’ll try to clarify a little.

My opinion is that the way it’s written is correct:
Suspect:
•A case with laboratory evidence of infection and either no clinical information available or not clinically compatible, OR
•A clinically compatible case (meets clinical criteria) that has supportive laboratory evidence.

“No clinical information available” and “not clinically compatible” are different. If there is laboratory evidence, then it should be a suspect case. This is consistent with what the current case definition is also.

Not a case would be a patient who presents with clinical symptoms that do not meet the case definition and do not laboratory evidence that meets any part of the case definition.

Hope this helps.

Thanks,
Kristen

Kristen Nichols Heitman, MPH
Epidemiologist
Rickettsial Zoonoses Branch, Centers for Disease Control and Prevention
wwd7@cdc.gov<mailto:wwd7@cdc.gov> | (404) 718-4670 Office | (404) 630-8736 Mobile | (404) 471-8820 Fax

May 13, 2019 at 4:55 PM Notified 9 people

Carl Williams

It seems like a simpler way to define suspect would be: A case with only laboratory evidence of infection.

Similar to suspect Lyme:

A case with evidence of infection but no clinical information available (e.g., a laboratory report).

Would that be accurate, and simpler?

May 13, 2019 at 5:37 PM Notified 9 people

Kristen Nichols Heitman

The SFR case classification currently has a similar description:
Suspected
A case with laboratory evidence of past or present infection but no clinical information available (e.g., a laboratory report).
I can’t remember who edited the description for the revision, but I think they were trying to capture those cases where clinical information is available, but doesn’t meet the clinical criteria in the case definition. I’m open to either way.

Kristen Nichols Heitman, MPH
Epidemiologist
Rickettsial Zoonoses Branch, Centers for Disease Control and Prevention
wwd7@cdc.gov<mailto:wwd7@cdc.gov> | (404) 718-4670 Office | (404) 630-8736 Mobile | (404) 471-8820 Fax

May 13, 2019 at 5:54 PM Notified 9 people

Abelardo Moncayo

Thanks. Why 10 weeks later for the second sample? Was it due to titers going down after 3 months?

May 13, 2019 at 6:35 PM Notified 9 people

Kristen Nichols Heitman

This was suggested by some of the RZB SMEs. We wanted to make sure the convalescent sample was taken with enough time for the titer to rise, if it is going to. While RMSF convalescence is better documented, the time it takes for other SFGR is less known.

Kristen Nichols Heitman, MPH
Epidemiologist
Rickettsial Zoonoses Branch, Centers for Disease Control and Prevention
wwd7@cdc.gov<mailto:wwd7@cdc.gov> | (404) 718-4670 Office | (404) 630-8736 Mobile | (404) 471-8820 Fax

May 13, 2019 at 6:38 PM Notified 9 people

Abelardo Moncayo

Thanks Kristen.

May 13, 2019 at 6:38 PM Notified 9 people

Kristen Nichols Heitman

Great job, Abelardo!

Kristen Nichols Heitman, MPH
Epidemiologist
Rickettsial Zoonoses Branch, Centers for Disease Control and Prevention
wwd7@cdc.gov<mailto:wwd7@cdc.gov> | (404) 718-4670 Office | (404) 630-8736 Mobile | (404) 471-8820 Fax

May 13, 2019 at 7:05 PM Notified 9 people

Abelardo Moncayo

Thank you! Thanks for being there to support!

May 13, 2019 at 7:15 PM Notified 9 people

Abelardo Moncayo

All - I would like to submit these changes in the attached document as the final document for the CSTE meeting. Essentially removing the "not clinically compatible" from the suspect category - found 3 times in the document (see track changes) - and removing the "O" from the last table under the elevated titer <1:128 lab evidence for the suspect category where no clinical information is available. Is everyone OK with that?

19-ID-07_Spotted Fever Rickettsiosis_NationalOfficeReviewed_EBApproved_Reconciliation_Updated Track Changes.docx 148 KB • Download

May 13, 2019 at 7:54 PM Notified 9 people