Size
of sample
service area
Number of reporting units, (e.g., labs, clinics, slaughter plants.)
Should include geographic area serviced per unit sampled.
Number of eligible units served by reporting unit (per unit of
geographic area being serviced).
Animal or group
type
The species, breed, and type (if applicable) of animals should be
evident; include breeds and crosses.
Define the animal by appropriate production phase concept.
Age categories should include all appropriate categories pertinent
to the surveillance objectives.
Date
Population description should include applicable date.
All date entries are as accurate as possible. At the minimum,
include the date of sample collection and date of lab diagnosis.
Report results are consistent using the defined date, (i.e., positive
scrapie date is NVSL confirmed date.)
Sampling process
Refer to standard 1.9, sampling methods.
Risk and
exposure factors
Population risk factors that may influence the outcome of the
study. Confounders should be included in the description of the
population (e.g., waste feeder hog operations).
Risk factors need to be identified for statistical analysis.
Anecdotal descriptions should not be used.
When populations under consideration have unique risk factors
or exposure to disease agents, the risk and exposure factors
under study (independent variables) should be carefully defined
to clearly differentiate the sectors of the population. If the
surveillance applies to waste feeder, transitional, and commercial
herds, risk/exposure factors must be clearly described prior to
sampling.
1.7 Case Definition
Standard:
The surveillance system has clear and understandable case definitions that
include criteria for diagnosis, laboratory criteria for confirmation, any restriction or
application of the case definition to specific geographical or demographic
characteristics, and descriptions of case classification categories.
a. The working case definition is clear and understandable by the individuals
who use it to identify and report cases.
b. Case definitions are consistent between all documents relating to a
surveillance system or program, (e.g., CFR, UM&R, VS policy memos, etc.)
c. Case definitions are specific enough to avoid counting cases in more than
one category.
d. Methods used to verify reported cases are clearly described.
e. The process is documented for handling data and information when case
definitions change.
Supporting Information:
A surveillance system depends on clear case definitions for animal health-related events under
surveillance. The case definition may include clinical manifestations (i.e., clinical signs);
laboratory test results; necropsy findings; epidemiologic information such as subject, place, and
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time; and/or specified behaviors, as well as levels of certainty including confirmed/definite,
probable/presumptive, or possible/suspected).
The use of a standard case definition increases the specificity of reporting and improves the
comparability of animal health-related events reported from different sources of data including
geographic areas, and minimizes inappropriate regulatory actions, (i.e., movement restrictions,
by placing cases in mutually exclusive categories.) Case definitions might exist for a variety of
animal health-related events under surveillance, including diseases, injuries, adverse exposures,
and risk factor or protective behaviors.
The following table provides guidelines on these classes of a case definition:
Class Guidelines
Clinical
description
Brief one- to two-paragraph synopsis of clinical signs, history, and
presentation.
Acute, chronic, and late onset forms of disease should be described.
Consideration should be given to asymptomatic or inapparent carrier
reservoirs that could play a role in disease transmission.
Clinical case
definition
A clinical case definition can be used to broaden or restrict the
sensitivity of a surveillance system by designating the species of
animal(s) under surveillance and inclusion or exclusion of clinical
signs or lesions for the disease or condition under investigation.
Animals meeting a clinical case definition may be used to screen for
inclusion of further testing.
Epidemiologic
criteria and
restrictions
Criteria may restrict case definition to individual animals, herds,
flocks, or premises that possess specific epidemiological
characteristics.
Criteria and restrictions may relate to the geographic location of an
animal, farm, or premises; a particular point in time or season of the
year; or a particular behavior associated with disease transmission or
risk factor.
Surveillance may be compartmentalized within a segment of a
vertically integrated industry, (e.g., genetic grandparent stock,
multipliers, commercial production); age group, (e.g., nursery vs.
weaners); or commodity type, (e.g., meat type chickens vs. layers.)
Criteria and restrictions should be used to clearly define population of
interest under surveillance. See standard 1.6.
May also include variables related to habitat, environmental
conditions, seasonality, climate, etc.
Laboratory criteria
May vary depending on the level of certainty required for surveillance.
Screening tests are generally performed rapidly, are usually widely
available within a laboratory system, and are relatively inexpensive.
They typically trade lower specificity for higher sensitivity, which
results in some level of false positive results. False negatives are
undesirable but may occur.
Confirmatory tests are typically less rapid and more difficult to
perform, are less readily available within a laboratory system because
of additional expertise needed to perform the test, and are more
expensive than more commonly used screening tests. The ideal
confirmatory test should be highly specific.
Laboratory tests may not always serve as the gold standard for
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