New CTSE Lyme Disease Case Definition 2017
To compare the previous Lyme disease case definitions to this latest one (2017)
Please see links to documents below.
This is more confusing than trying to put socks
On a school full of 3-legged 4 year olds!
Lyme Disease (Borrelia burgdorferi)
2017 Case Definition
CSTE Position Statement(s)
16-ID-10
Clinical Description
A systemic, tick-borne disease with protean manifestations, including dermatologic, rheumatologic, neurologic, and cardiac abnormalities. The most common clinical marker for the disease is erythema migrans (EM), the initial skin lesion that occurs in 60%-80% of patients.
For purposes of surveillance, EM is defined as a skin lesion that typically begins as a red macule or papule and expands over a period of days to weeks to form a large round lesion, often with partial central clearing. A single primary lesion must reach greater than or equal to 5 cm in size across its largest diameter.
Secondary lesions also may occur. Annular erythematous lesions occurring within several hours of a tick bite represent hypersensitivity reactions and do not qualify as EM. For most patients, the expanding EM lesion is accompanied by other acute symptoms, particularly fatigue, fever, headache, mildly stiff neck, arthralgia, or myalgia. These symptoms are typically intermittent.
The diagnosis of EM must be made by a physician. Laboratory confirmation is recommended for persons with no known exposure.
For purposes of surveillance, late manifestations include any of the following when an alternate explanation is not found:
Musculoskeletal system . Recurrent, brief attacks (weeks or months) of objective joint swelling in one or a few joints, sometimes followed by chronic arthritis in one or a few joints.
Manifestations not considered as criteria for diagnosis include chronic progressive arthritis not preceded by brief attacks and chronic symmetrical polyarthritis. Additionally, arthralgia, myalgia, or fibromyalgia syndromes alone are not criteria for musculoskeletal involvement.
Nervous system . Any of the following signs that cannot be explained by any other etiology, alone or in combination: lymphocytic meningitis; cranial neuritis, particularly facial palsy (may be bilateral); radiculoneuropathy; or, rarely, encephalomyelitis. Headache, fatigue, paresthesia, or mildly stiff neck alone, are not criteria for neurologic involvement.
Cardiovascular system . Acute onset of high-grade (2nd-degree or 3rd-degree) atrioventricular conduction defects that resolve in days to weeks and are sometimes associated with myocarditis. Palpitations, bradycardia, bundle branch block, or myocarditis alone are not criteria for cardiovascular involvement.
Laboratory Criteria for Diagnosis
For the purposes of surveillance, laboratory evidence includes:
A positive culture for B. burgdorferi, OR
A positive two-tier test. (This is defined as a positive or equivocal enzyme immunoassay (EIA) or immunofluorescent assay (IFA) followed by a positive Immunoglobulin M1 (IgM) or Immunoglobulin G 2 (IgG) western immunoblot (WB) for Lyme disease) OR
A positive single-tier IgG2 WB test for Lyme disease3.
1 IgM WB is considered positive when at least two of the following three bands are present: 24 kilodalton (kDa) outer surface protein C (OspC)*, 39 kDa basic membrane protein A (BmpA), and 41 kDa (Fla). Disregard IgM results for specimens collected >30 days after symptom onset.
2 IgG WB is considered positive when at least five of the following 10 bands are present: 18 kDa, 24 kDa (OspC)*, 28 kDa, 30 kDa, 39 kDa (BmpA), 41 kDa flagellin (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa.
3 While a single IgG WB is adequate for surveillance purposes, a two-tier test is still recommended for patient diagnosis.
*Depending upon the assay, OspC could be indicated by a band of 21, 22, 23, 24 or 25 kDA.
Criteria to Distinguish a New Case from an Existing Case
Case not previously reported to public health authorities.
Exposure
Exposure is defined as having been (less than or equal to 30 days before onset of EM) in wooded, brushy, or grassy areas (i.e., potential tick habitats) of Lyme disease vectors. Since infected ticks are not uniformly distributed, a detailed travel history to verify whether exposure occurred in a high or low incidence state is needed.
An exposure in a high-incidence state is defined as exposure in a state with an average Lyme disease incidence of at least 10 confirmed cases/ 100,000 for the previous three reporting years. A low-incidence state is defined as a state with a disease incidence of <10 confirmed cases/100,000 (see https://www.cdc.gov/lyme/stats/tables.html). A history of tick bite is not required.
Case Classification
Suspected
A case of EM where there is no known exposure (as defined above) and no laboratory evidence of infection (as defined above), OR
A case with evidence of infection but no clinical information available (e.g., a laboratory report).
Probable
Any other case of physician-diagnosed Lyme disease that has laboratory evidence of infection (as defined above).
Confirmed
A case of EM with exposure in a high incidence state (as defined above), OR
A case of EM with laboratory evidence of infection and a known exposure in a low incidence state, OR
Any case with at least one late manifestation that has laboratory evidence of infection.
Case Classification Comments
Lyme disease reports will not be considered cases if the medical provider specifically states this is not a case of Lyme disease, or the only symptom listed is "tick bite" or "insect bite."
Related Case Definition(s)
Lyme Disease (Borrelia burgdorferi) | 2011 Case Definition
Lyme Disease (Borrelia burgdorferi) | 2008 Case Definition
Lyme Disease (Borrelia burgdorferi) | 1996 Case Definition
Lyme Disease (Borrelia burgdorferi) | 1995 Case Definition
*** The CDC website announced this new 2017 version of the case definition with the following information provided. Notice the reporting forms (2nd link) have not been updated. Also see their "Note" below.
Case Definition and Report Forms
- Lyme Disease Surveillance Case Definition (revised Jan 2017)
- Lyme Disease Surveillance Case Report Form[PDF – 2 pages] (for public health officials’ use)
Note: Surveillance case definitions establish uniform criteria for disease reporting and should not be used as the sole criteria for establishing clinical diagnoses, determining the standard of care necessary for a particular patient, setting guidelines for quality assurance, or providing standards for reimbursement.
Additional Information/Explanations
Additional Documents
CSTE 1996 Update
http://c.ymcdn.com/sites/www.cste.org/resource/resmgr/PS/07-ID-11.pdf
Washington State DOH Definition & Procedures
http://www.doh.wa.gov/Portals/1/Documents/5100/420-061-Guideline-Lyme.pdf
Canada- Lyme Disease Cases Definition
http://www.health.gov.on.ca/en/pro/programs/publichealth/oph_standards/docs/lyme_disease_cd.pdf
Canada 2016 Definition
Canada- Update on Case Definition & Treatment 2016
QUOTE- "An effective public health framework should consider both the evidence-based approaches to true Lyme disease, and develop a rational response to ‘chronic Lyme’ disease, a phenomenon that has attracted patient activism as well as supporting institutions parallel to the scientific and medical establishment. These support an alternative understanding of the disease, one that emphasizes unsupported diagnostic and treatment protocols and an invalid view of the infection process. This creates a real burden of suffering in people who believe themselves to be infected with a refractory Lyme infection, and seek out sometimes-dangerous treatment. Situations in which the patient’s felt needs are strongly at variance with the clinician’s informed opinion are rarely simple; here it is helpful to remember that though ‘chronic Lyme’ is an unproven illness, the symptoms that trigger the diagnosis are frequently real and need empathetic care."
https://nccid.ca/publications/lyme-disease-in-canada-an-update-on-case-definitions-and-treatments/
Florida DOH Reporting Form
Maine’s Definition Info
https://www1.maine.gov/dhhs/mecdc/infectious-disease/epi/publications/lyme-surv-poster.pdf
EPA Report
https://www.epa.gov/sites/production/files/2016-08/documents/lyme_documentation.pdf
Reported Cases in New Hampshire
https://www.dhhs.nh.gov/dphs/cdcs/lyme/documents/county2015.pdf
2017 CSTE Case Definition
2017- The CSTE Lyme Disease Case Definition was last updated in 2011. This is their new 2017 version, with additional links to the older versions for comparison purposes at the bottom of the page. There is also a note from the CDC relating to this new definition, but it is NOT included in the actual definition. It was found on another page.
https://sites.google.com/site/marylandlyme/reported-cases/2017-cdc-case-definition
It is sad that results of some of the best tests can't be used for confirming cases, which we know is basically the same as what will be used to determine treatments, and be linked to denials of insurance reimbursements. And no IgM positives will be accepted if not positive within the first 30 days.
Most states (37) will not have confirmed reported cases of Lyme disease unless patients have an EM rash diagnosed by a physician, AND a known exposure, AND positive 2 tier lab tests; or at least one late manifestation and a positive two-tier test.
And how many people don’t remember a tick bite, don’t get a rash and/or don’t have positive tests? TOO MANY!
QUOTE- "A case of EM with exposure in a high incidence state (as defined above), OR
A case of EM with laboratory evidence of infection and a known exposure in a low incidence state, OR
Any case with at least one late manifestation that has laboratory evidence of infection."
And… they are basing the new 2017 description of a "reported case" on numbers previously taken from their own extremely poor reporting system.
I’d say fix THAT first (which they will never do), then they can use it as a basis to move forward with this strangling, messy case definition. When the foundation is as weak as this is, the resulting numbers will be even more flawed.
And… they only used previously “confirmed" cases to determine their new 3 year average incidence rates shown below. “Suspect" and “probable" cases didn’t and won't count in that figuring. In the future, more suspected and probable cases will be the norm based on this definition, if the cases are counted at all.
QUOTE- "An exposure in a high-incidence state is defined as exposure in a state with an average Lyme disease incidence of at least 10 confirmed cases/ 100,000 for the previous three reporting years. A low-incidence state is defined as a state with a disease incidence of <10 confirmed cases/100,000 (see https://www.cdc.gov/lyme/stats/tables.html)."
Here is a document from the CSTE that appears to explain why the definition was written this way.
http://c.ymcdn.com/sites/www.cste.org/resource/resmgr/2016PS/16_ID_10.pdf
This is more confusing than trying to put socks on a school full of rambunctious 3-legged 4 year olds!