TOTAL ANALYTIC ERROR

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Today clinical laboratories have come under
increased pressure to implement quality
systems and new risk management guidelines
for quality control in order to ensure timely and
accurate delivery of test results.
However, one issue that is often overlooked in
these efforts is the actual quality goal or
requirement for a laboratory test.

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An effective system for managing
analytical quality can be developed
based on the concept of total
analytic error (TAE)
Total error: The net or combined
effect of the random and systematic
errors.

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The concept of TAE is an effort to provide a more
quantitative approach for judging the acceptability
of method performance. At that time, the practice
used by laboratories considered precision
(imprecision) and accuracy (inaccuracy, bias) as
separate sources of errors and evaluated their
acceptability individually. the authors
recommended that the acceptability of method
performance be judged on the sizes of the observed
errors relative to a defined allowable total error
(ATE).

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Estimating Total Analytic Error
 laboratories estimate TAE by combining the estimate
of bias from a method comparison study and the
estimate of precision from a replication study.
Accordingly, using a multiple of the standard
deviation (SD) or coefficient of variation (CV).
 TAE = bias + 2 SD for a 95% confidence interval or
limit of the possible analytic error.

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Total Analytic Error Concept

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allowable total error,
TEa: The total amount of analytical error that
can be tolerated without invalidating the
medical usefulness of the analytical result.
TEa can be used to decide the acceptability of a
measurement procedure in method evaluating
testing, or to calculate the size of medically
important errors

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Medically important errors:
Those errors that, when added to the inherent
imprecision and inaccuracy of a measurement
procedure, cause the total error specification
to be exceeded.

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 allowable total error,( TEa)
It depend on:
1. Biological source of variation.
2. medical decision limit – the value for a test result
that is used in making the diagnosis. It is also helpful
for physicians to have a cutoff value to associate with
specific diseases.
In fact, that is the basic purpose of laboratory tests
with the goal of detecting disease in its early stages.
For example, a fasting plasma glucose of 126 mg/dL
is used to classify diabetes.

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Medical decision levels are the concentrations
at which the test results are critically
interpreted for purposes of diagnosis,
monitoring, and therapeutic decisions
3. Critical Values
Critical values, are medical decision level
concentrations that would indicate a potentially
or imminently life threatening situation.

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 When a critical value is obtained, it is necessary to
quickly notify the clinical team for immediate patient
evaluation and treatment. The list should only include
tests that are essential for the acute treatment of
patients.
 Glucose, potassium, magnesium, sodium, total CO2,
inorganic phosphorus, calcium, and blood gases are
examples of tests requiring critical value limits.

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 Thank you

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