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Laboratory Interpretation of Case Definitions Stefani Ruiz, MHS, Epidemiologist USAFSAM Epidemiology Consult Service/ PHR [email protected] DSN: 798-3205 Commercial: 937-938-3205

Debunking Laboratory Jargon

Format  The

lab test  What to look for in AHLTA  How to report in DRSi

2012 Armed Forces Guidelines All laboratory tests and case definitions in this presentation come from the 2012 Guidelines

How to get a copy: 

Army:http://phc.amedd.army.mil/TOPICS/HEALT HSURV/DE/Pages/DRSiResources.aspx



Navy:http://www.med.navy.mil/sites/nmcphc/progr am-and-policy-support/diseasesurveillance/Pages/default.aspx



AF: http://gumbo2.area52.afnoapps.usaf.mil/epiconsult/reportableevents/



AFHSC:http://www.afhsc.mil/Home/Reportable Events

Laboratory Language  

   

IgM vs. IgG 4-fold rise = acute and convalescent = paired sera Titer EIA/ELISA 2-tiered testing Seroconversion

  

  

Rapid Flu test PCR vs. RT-PCR Novel flu labs Isolation = culture Smear = microscopy = slide HIV

IgM vs. IgG Ig=Immunoglobulin 

IgM Antibody  Produced

first in response to infection  Marker of current infection  Detectable only about 2-6 months



IgG Antibody  Produced

later in response to infection  Marker of long-term immunity 

from vaccination or disease

IgM and IgG Example: Hepatitis A Labs

Case definition excerpt comes from the 2012 Armed Forces Guidelines

Hepatitis A Lab Results in AHLTA Hepatitis A Virus Ab Total: Positive Hep A Virus total antibody is positive (Total antibody includes IgG and IgM)

This would not meet the case definition

Hepatitis A Lab Results in AHLTA Hepatitis A Virus Ab Total: Positive Hepatitis A Virus Ab IgM: Equivocal

This would not be reportable.

Hepatitis A Lab Results in AHLTA Hepatitis A Virus Ab IgM: Positive This would be reportable so long as the rest of the case definition has been met:

Case definition excerpt comes from the 2012 Armed Forces Guidelines

Need to be symptomatic

DRSi: Hepatitis A

4-fold rise in serum antibody titer

Case definition excerpt comes from the 2012 Armed Forces Guidelines

4-fold = acute and convalescent = paired sera 4-fold = concentration (titer) of IgG in the 2nd sera (convalescent) needs to be ≥ 4 fold higher than in the 1st sera (acute). Titer = measurement indicating concentration of antibodies (IgG) as performed by serial dilutions Paired = 2 samples A single serology DOES NOT count

4-fold picture

Concentration of IgG at week b needs to be ≥4 fold higher than the 1st sera at week a. Week3a Week

Week b

4-fold math If the acute serum is

1:8 1:16 1:32 1:64 1:128

Starting point 1- fold serial dilution 2- fold serial dilution 3- fold serial dilution 4- fold serial dilution

Then the convalescent serum must be at least 1:128 to meet the 4-fold definition. These are serial dilutions: if pos at a higher titer, it means antibody is still detectable at a higher dilution so you have more antibody

4-fold rise in serum antibody titer 

Note in the above example:  AHLTA

will only report out the titers  You have to do the math to know if there is a 4-fold increase 

2 serologies separated by @ least 2 weeks  Some



case definitions require @ least 3 weeks

Not done frequently  MD’s

don’t want to wait

Measuring antibody concentration: EIA / ELISA  



EIA = Enzyme immunoassay ELISA (a type of EIA) = Enzyme linked immunosorbent assay Test detects antigen from the organism or antibody (IgG or IgM) against the organism antibody

antigen

Measuring antibody concentration: EIA / ELISA 

For the Campy example, this EIA is detecting Campylobacter antigen  found

in stool

Case definition excerpt comes from the 2012 Armed Forces Guidelines

Measuring antibody concentration: EIA / ELISA 

For the Coccidioidomycosis example, the EIA is detecting IgM or IgG antibodies against the organism  found

in any body fluid.

Case definition excerpt comes from the 2012 Armed Forces Guidelines

EIA / ELISA Back to Hep A Both of these could be performed through EIA’s.

Case definition excerpt comes from the 2012 Armed Forces Guidelines

The trick with the case definitions: sometimes the laboratory method is specifically named, and sometimes not.

2-tiered testing: Lyme disease 2 tiered testing ≠ paired sera

 1st 

Case definition excerpt comes from the 2012 Armed Forces Guidelines

tier: EIA or IFA If positive/equivocal, then 2nd tier: IgM or IgG Western Blot 

Centers for Disease Control and Prevention. Recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR MMWR Morb Mortal Wkly Rep 1995; 44:590–1.

DRSi: Lyme

Seroconversion 

Sero: root word is “serum”  So

looking for IgM or IgG in serum



Conversion: changing from 1 form to another



Converting from negative IgM to positive IgM  or



from negative IgG to positive IgG

Still need to find 2 serologies in AHLTA  Single

serologies do not count

Seroconversion: Examples of Case Definitions 

Dengue Case definition excerpt comes from the 2012 Armed Forces Guidelines

 Translation:

Seroconversion from a negative IgM in an acute sera to pos IgM in convalescent sera



Mumps Case definition excerpt come from the 2012 Armed Forces Guidelines

 Translation:

Seroconversion from negative IgG to positive IgG in acute and convalescent serum

DRSi: Dengue seroconversion

Influenza

Case definition excerpt comes from the 2012 Armed Forces Guidelines

Influenza Lab Results in AHLTA Influenza A+B Virus Ag 

  

Rarely does AHLTA use the word “rapid” Most of the time, it will say just “Ag”. It’s detecting flu Antigen. “Ag” your tip off that this is a rapid antigen test (RAT).

Influenza Lab Results in AHLTA Influenza A+B Virus Ag Influenza Virus A Ag: Positive Influenza Virus B Ag: Negative This person has Flu A, as performed by a rapid test

Case definition excerpt comes from the 2012 Armed Forces Guidelines

Before reporting in DRSi, also check to make sure person is <65 yrs of age and hospitalized. Only report flu if the patient is hospitalized and under 65 yrs of age.

Reporting this patient The underlying method of the rapid test is antibody/antigen detection (EIA) which is a serologic test

AHLTA: Different Flu Patient Respiratory Virus Panel Respiratory Viral Culture: Influenza Virus Type A Influenza Virus A+B DNA: 2009 Influenza A(H1N1)  

In this case a Respiratory Virus Panel includes Culture and DNA (AHLTA really means RNA) Both are positive  Culture

has identified the type: Flu A  DNA has identified the subtype: A(H1N1) 

Our patient has Flu A, specifically A(H1N1)

Case definition excerpt comes from the 2012 Armed Forces Guidelines



When the case definition says  …“Detection



of influenza-specific RNA”

And AHLTA says “Influenza Virus A+B DNA”  …for

the purposes of meeting the case definition, they’re the same thing.

Case definition excerpt comes from the 2012 Armed Forces Guidelines



When the case definition says  …“Detection……by



RT-PCR ”

And AHLTA says “Influenza Panel PCR”  …for

the purposes of meeting the case definition, they’re the same thing.

Each MTF has a different way of reporting out results AHLTA is designed differently at every MTF  Talk to your lab people to find out how they code their tests and their results  Also note: some positive results are in red, some are not – don’t get fooled! 

Reporting this patient

We do not want you to report like this.

Once a lab test is selected, it can not be deselected. Have to delete the record and start a new DRSi report.

DRSi: How is this Influenza Report? Type in the chat box

DRSi: How is this report? Type in the chat box

Method of confirmation

Case (classification) status

Laboratory criteria

Before submitting all DRSi reports, please make sure that Method of Confirmation, Case (classification) status, and Lab criteria are congruent with each other as well as the case definition.

What’s in a Name: Novel Flu 

 

A new flu virus Has never circulated in humans before Therefore:  No

immunity  No vaccine  Could cause high morbidity/mortality  Rampant transmission: Global pandemic 

dartmed.dartmouth.edu

Though it shares the same name, it is not the same thing as Seasonal Flu Novel flu ≠ Seasonal flu Novel flu ≠ New flu diagnosis in a patient

If there were sustained novel flu transmission, there would be a global crisis 

   

WHO would declare an emergency of international concern Markets would shut down Panic would be rampant Would be all over media outlets It is a BIG deal

If the physician’s diagnosis says: “Influenza due to identified novel influenza A virus with other respiratory manifestations” And AHLTA says: Influenza Virus A+B Virus Ag: Influenza Virus A

Do Not Report This as Novel Flu (The only way to identify novel flu is through PCR)

Reporting Novel Flu Generates Command Level Attention 

Don’t report it  (unless

you are told to report it that way by your chain of command.)



H1N1 is no longer novel  In



2009 it was novel, but it no longer is.

H3N2 is NOT novel  (H3N2)v

is novel  Don’t confuse the two 

If you have question about novel flu, call your service hub or the USAFSAM Epi lab.

What’s in a name: H. flu Haemophilus influenza (H. flu) (a bacteria)

≠ Influenza (Flu) (a virus)

Isolation = Culture 

Regardless if referring to bacteria or virus.

Case definition excerpt comes from the 2012 Armed Forces Guidelines

Case definition excerpt comes from the 2012 Armed Forces Guidelines

In AHLTA you will not see the word “isolation”. You will see “culture”. They are synonymous

Reporting Campy

New in DRSi: Chikungunya 

Only report Confirmed cases



Case definition is located here: http://www.afhsc.mil/documents/pubs/docu ments/Detecting_and_Reporting_DoD_Case s_of_Chikungunya_25JUL2014.pdf



Air Force and Navy are using an updated draft case definition that includes laboratories:

Chikungunya Lab Results in AHLTA Chikungunya virus Ab Chikungunya virus IgG: Positive Chikungunya virus IgM: Positive

New in DRSi: Chikungunya Page

No longer reportable as “Any other unusual condition not listed”

Smear = microscopy = slide = film



Obvious case definition examples: (confirmed) – detection of malaria on blood film  Gonorrhea  Malaria 



(confirmed): Observation of gram-negative intracellular diplococci in a urethral smear obtained from a male. (probable): Demonstration of gram-negative intracellular diplococci in an endocervical smear obtained from a female

Case definitions taken from the 2012 Armed Forces Guidelines

Smear = microscopy = slide = film



Not so obvious examples: (probable) – demonstration of acid fast bacillus in a clinical specimen

 TB 

Look at the color of bacterial cell wall under the microscope

Disease (suspected) – gram negative diplococci from sterile site

 Meningococcal 

Look at color and shape of the bacteria under the microscope

 Giardia

stool

(confirmed): observation of cysts or trophozoites in Case definitions taken from the 2012 Armed Forces Guidelines

Serology (serologic test method)  Any EIA/ELISA test method  Rapid flu test

Clinical 

Things that don’t require labs to confirm:  Any 

case definition that only requires sign/symptoms

Cold weather, heat illnesses, some definitions of Lyme, suspect measles

Other 

Any genetic/DNA tests: PCR, RT-PCR, probe

HIV/AIDS is not reportable to DRSi

DRSi Helpdesk e-mails 

Navy and Air Force (share the Navy DRSi Helpdesk) 

[email protected]  !This is a new address!



Army DRSi Helpdesk: 

  

[email protected]

Use these addresses to send your completed DD2875 forms Or for any technical DRSi issues Continue to reach out to your respective service hub for all other issues  (comm

disease issues, outbreaks, case definition guidance, etc)

Contact Information USAPHC – Disease Epidemiology Program Aberdeen Proving Ground – MD Comm: (410) 436-7605 DSN: 584-7605 [email protected]



Army:



Air Force: Contact your MAJCOM PH or USAFSAM/PHR USAFSAM / PHR / Epidemiology Consult Service Wright-Patterson AFB, Ohio Comm: (937) 938-3207 DSN: 798-3207 [email protected]

Contact Information Navy: NMCPHC Preventive Medicine Department  

COMM: (757) 953-0700; DSN: (312) 377-0700 Email: [email protected]

Navy Environmental and Preventive Medicine Units (NEPMU) 







NEPMU2  COMM: (757) 953-6600; DSN: (312) 377-6600  Email: [email protected] NEPMU5  COMM: (619) 556-7070; DSN (312) 526-7070  Email: [email protected] NEPMU6:  COMM: (808) 471-0237; DSN: (315) 471-0237  Email: [email protected] NEPMU7  COMM (international): 011-34-956-82-2230 (local: 727-2230); DSN: 94314-727-2230  Email: [email protected]

Conclusion    



Gone through case definitions from a laboratory perspective Understood laboratory terminology Reviewed DRSi reporting Moral of the story: if the case definitions change, the principles of how to read AHLTA or how to read a case definition do not. For more information on laboratory interpretation:  Talk

to your lab officer  http://labtestsonline.org/map/aindex/

Questions

DCO Registration Please register using the two simple steps below: 1. Log-in or create a CME account: http://tiny.army.mil/r/zB8A/CME

**Tip: If your facility is not listed as an option on the registration form, please select "OTHER/MEDCOM“ 2. Register for Epi-Tech Surveillance Training series: http://tiny.army.mil/r/LEAid/EpiTechFY15

If you have any questions contact the DCO help desk at: [email protected]

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AHLTA - Navy Medicine - Navy.mil

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