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Title: 01_PREDICTIVE VALUE OF LAB TESTS 2016_student
Author: George Kudolo

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Role of The Clinical Chemistry
Laboratory in Patient Care

George B. Kudolo, PhD, FAIC, CPC, FACB
Department of Clinical laboratory Sciences

At the end of this lecture, the student
should be able to:
¡ Name the major criteria for clinical decision-making in
medical diagnosis
¡ Define a “Gaussian distribution” in terms of data
¡ Describe how reference intervals are obtained
¡ List the criteria for excluding reference individuals
¡ Describe the reference intervals for the basic
metabolic panel
¡ Describe the 2 distinguishing characteristics of
diagnostic tests
¡ Describe the distinguishing features of the AMA
Defined Test Panels

The Value of Laboratory Testing

¡ In order to improve outcomes,
a laboratory test must be
appropriately ordered,
conducted, returned with
results on a timely basis,
correctly interpreted and
affect a decision for further
diagnosis and treatment

Lewin Group report on The Value of Laboratory Screening and
Diagnostic Tests for the Prevention and Health Care
Improvement, 2009

Medical Diagnosis
¡ Physician & patient exchange
information recognize
¡ Physician exam - recognize
signs & symptoms
¡ Make diagnosis?
¡ Control Pain/symptoms?
¡ Unsure?
¡ Order Lab tests
¡ Review results & make diagnosis
¡ Initiate Treatment

The 9 Steps In The Performance Of
Laboratory Tests

Order test

Sample Collection


ID verification





The Diagnostic Process

Clinical Decision Limits

Decision is based on information
concerning specific medical conditions
¡ Reference Intervals
¡ Critical/Panic Values
¡ Diagnostic cut-offs
¡ Therapeutic windows/ranges

The Reference Range
¡ Range of “normal” values upon which medical decision
is based
¡ Mean ± 2SD

Critical value



Critical value






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