3 - Diagnostic Accuracy in Clinical Laboratories

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Questions and Answers

What is indicated by a high sensitivity in a diagnostic test?

  • The test correctly identifies a high proportion of individuals with the disease. (correct)
  • The test correctly identifies a high proportion of individuals without the disease.
  • The test is accurate in all cases.
  • The test has a low rate of false positives.

Which of the following best describes the purpose of a 'gold standard' in diagnostic accuracy assessment?

  • It represents the results of a test performed under ideal laboratory conditions.
  • It is an established diagnostic test or method considered to be the most accurate for a particular condition, against which new tests are evaluated. (correct)
  • It represents the average result obtained from a series of routine tests.
  • It refers to a test that is universally accessible and affordable.

In the context of a 2x2 truth table used in diagnostic accuracy, what does a 'False Positive' (FP) represent?

  • A test result that correctly indicates the presence of a disease.
  • A test result that incorrectly indicates the presence of a disease when the disease is actually absent. (correct)
  • A test result that correctly indicates the absence of a disease.
  • A test result that incorrectly indicates the absence of a disease when the disease is actually present.

What distinguishes diagnostic accuracy from diagnostic precision?

<p>Accuracy is the closeness of the measurement to the true value, while precision is the repeatability of the measurement. (A)</p> Signup and view all the answers

According to the information, what is the primary reason for the potential repetition of tests in clinical laboratories?

<p>To confirm results due to the overlap between populations at cut-off points. (C)</p> Signup and view all the answers

What factors can influence reference values in clinical chemistry?

<p>All of the above (D)</p> Signup and view all the answers

How is overall accuracy calculated?

<p>$(TP + TN) / (TP + TN + FP + FN)$ (A)</p> Signup and view all the answers

What is the primary reason for using well-defined references in studies?

<p>To account for variations due to changes in diet and maintenance. (D)</p> Signup and view all the answers

Why is the material of the sample collection container a critical consideration?

<p>Materials like plastic can react with the analyte, skewing results. (D)</p> Signup and view all the answers

Which timeline consideration is most critical for arterial blood gas tests?

<p>The interval between specimen collection and analysis. (C)</p> Signup and view all the answers

Prior to 1993, which aspect of reference value studies was notably lacking?

<p>There were guidelines available on how to conduct studies establishing reference values. (A)</p> Signup and view all the answers

According to the 1993 CLSI and IFCC guidelines, what is the key distinction between healthy reference values and patient reference values?

<p>Healthy values are measured in healthy populations, while patient values are measured in patients with diseases. (C)</p> Signup and view all the answers

What is the primary purpose of establishing reference values in laboratory medicine?

<p>To replace the concept of normal values with a more accurate and standardized approach for interpreting blood analyte concentrations (B)</p> Signup and view all the answers

Which factor is LEAST likely to influence reference intervals?

<p>Laboratory Technician's Preference (C)</p> Signup and view all the answers

What is a specific example of an environmental factor influencing reference values?

<p>Higher Vitamin D levels through exposure to sunlight (A)</p> Signup and view all the answers

Why might international reference ranges not always be directly applicable to all individuals?

<p>Differences in sex and race may necessitate population-specific reference ranges. (D)</p> Signup and view all the answers

What was a previous term that was used for reference values?

<p>Normal Values (C)</p> Signup and view all the answers

When was the term 'reference values' most notably used?

<p>1987 to 1991 (B)</p> Signup and view all the answers

In what aspect of laboratory medicine does the term 'reference values' aid?

<p>Helps in the clinical decision-making process (C)</p> Signup and view all the answers

What is NOT a valid reason for why different populations need different reference ranges?

<p>Because of the weather (C)</p> Signup and view all the answers

Where should the term 'reference values' be used?

<p>Field of laboratory medicine (D)</p> Signup and view all the answers

What is one of the benefits of the term 'reference values'?

<p>It can aid in standardization (C)</p> Signup and view all the answers

What does a higher Positive Predictive Value (PPV) indicate?

<p>A greater proportion of patients with positive test results who actually have the disease. (C)</p> Signup and view all the answers

If a test's Negative Predictive Value (NPV) is low, what is the most likely implication?

<p>The test is missing many true positives. (C)</p> Signup and view all the answers

A laboratory decreases the significant figures reported for a test result. Which type of error is most likely to increase?

<p>False Negative (C)</p> Signup and view all the answers

Decreasing the significant figures reported for a test result will primarily affect which measure?

<p>Sensitivity (B)</p> Signup and view all the answers

A new diagnostic test initially demonstrates high accuracy in a controlled clinical trial. What is most likely to happen as the test is used more broadly across a larger population?

<p>The test's accuracy will decrease if the disease prevalence differs in the broader population. (C)</p> Signup and view all the answers

What is the most appropriate criteria for lab result value determination?

<p>Values, Limits, Intervals or Ranges (D)</p> Signup and view all the answers

Consider a diagnostic test where increasing the cut-off value to determine a positive result leads to fewer false positives. What is the most likely tradeoff?

<p>Decreased Sensitivity (A)</p> Signup and view all the answers

In the context of diagnostic testing, what does 'reference range' primarily indicate?

<p>The range of values considered normal for a test. (A)</p> Signup and view all the answers

What is the relationship between false negatives and sensitivity?

<p>Increased false negatives decrease sensitivity (A)</p> Signup and view all the answers

A test's accuracy will change primarily due to what?

<p>The prevalence of the disease/analyte varies (C)</p> Signup and view all the answers

Which of the following is the correct formula for calculating accuracy?

<p>($TP + TN$) / ($TP + TN + FP + FN$) (A)</p> Signup and view all the answers

If a test has a high sensitivity, what does this indicate?

<p>It accurately identifies almost all individuals with the disease. (A)</p> Signup and view all the answers

A screening test for a contagious disease needs to have a high...

<p>Sensitivity (A)</p> Signup and view all the answers

In a diagnostic test, what does a 'true positive' result indicate?

<p>The test correctly identifies someone who has the disease. (A)</p> Signup and view all the answers

In the sample problem, what does the value '8' represent in the 'No Disease' column and 'Positive' row?

<p>False Positives (A)</p> Signup and view all the answers

A new diagnostic test for a rare disease demonstrates high sensitivity. What is a likely implication of this?

<p>The test will likely identify most individuals who have the disease. (A)</p> Signup and view all the answers

What would be the 'total' number of people who returned a positive test result for Hepatitis B virus?

<p>128 (B)</p> Signup and view all the answers

A clinic is deciding between two tests for a highly contagious respiratory virus. Test A has a sensitivity of 95%, and Test B has a sensitivity of 80%. Which test would be more suitable for initial screening, and why?

<p>Test A, because it is less likely to miss infected individuals. (C)</p> Signup and view all the answers

In the context of diagnostic accuracy, what does the term 'gold standard' refer to?

<p>A reference test or method that is considered the most accurate for confirming a diagnosis. (A)</p> Signup and view all the answers

Flashcards

Diagnostic Accuracy

The degree to which a diagnostic test correctly identifies or excludes a condition.

Sensitivity

The ability of a test to correctly identify true positives (TP).

Specificity

The ability of a test to correctly identify true negatives (TN).

Gold Standard

The best available method for confirming a diagnosis, used for comparison.

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Overall Accuracy Formula

The formula to calculate diagnostic accuracy: (TN + TP) / (TN + TP + FP + FN).

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Reference Values

Established values used to interpret test results, indicating normal or abnormal.

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Choosing Reference Interval

The process of selecting appropriate cut-off points for test results.

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Overall Accuracy

The measure of how often a model correctly classifies instances, calculated as (TN + TP) / (TN + TP + FP + FN).

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True Positive (TP)

The number of cases where the test correctly identifies the presence of disease.

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True Negative (TN)

The number of cases where the test correctly identifies the absence of disease.

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False Positive (FP)

The number of cases where the test incorrectly indicates the presence of disease.

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False Negative (FN)

The number of cases where the test fails to identify a disease that is present.

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CLSI

Clinical Laboratory Standard Institute, which publishes clinical guidelines.

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IFCC

International Federation of Clinical Chemistry, involved in laboratory practices.

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Sample Storage

Conditions required for storing samples before analysis.

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Healthy vs Diseased Reference Values

Reference values differ based on whether individuals are healthy or diseased.

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Fluctuations in Blood Analytes

Variations in the concentrations of substances in the blood over time.

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Normal Values

The outdated concept of average blood analyte levels which may not be accurate.

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Nomenclature in Lab Medicine

A system of names and terms used to standardize practices in laboratory testing.

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Environmental Factors

External conditions that can affect blood analyte levels.

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Age Differences

Variations in blood analyte levels based on age—children vs. elderly.

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Population Differences

Variations in reference values based on genetic background, sex, and race.

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Clinical Decision-Making

The process of making informed choices based on laboratory test results.

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High Altitude Effects

Increased hemoglobin levels due to lower oxygen levels at high altitudes.

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Vitamin D Levels

Concentrations of Vitamin D in the blood, often higher with increased sunlight exposure.

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Positive Predictive Value (PPV)

The probability that subjects with a positive test truly have the disease.

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Negative Predictive Value (NPV)

The probability that subjects with a negative test truly do not have the disease.

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False Negative

A test result that incorrectly indicates no disease when it is present.

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Rounding Effects on Results

Changing significant figures may lead to misclassification of test results.

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Cut-off Value

A threshold set to distinguish between different test results for diagnosis.

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Reference Range

A range of values used to interpret test results; indicates healthy limits.

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Initial Validation Studies

Early tests performed on a small group to confirm a test's effectiveness.

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Study Notes

Diagnostic Accuracy

  • Diagnostic accuracy measures the closeness of a measurement to its true value.
  • Precision measures the closeness of agreement amongst results.
  • Ideal tests have high accuracy and precision.

Concepts in Diagnostic Accuracy

  • Gold Standard: A thoroughly tested, authoritative method, considered the definitive benchmark in determining the presence or absence of a condition.
  • Four Groups in the 2x2 Truth Table:
    • True Positive (TP): Correctly identified as having the disease.
    • True Negative (TN): Correctly identified as not having the disease.
    • False Positive (FP): Incorrectly identified as having the disease.
    • False Negative (FN): Incorrectly identified as not having the disease.
  • Overall Accuracy: The proportion of correct classifications.
    • Formula: (TN + TP) / (TN + TP + FP + FN)

Sensitivity and Specificity

  • Sensitivity: The proportion of people with the disease who test positive.
    • Formula: TP / (TP + FN)
  • Specificity: The proportion of people without the disease who test negative.
    • Formula: TN / (TN + FP)

Predictive Values

  • Positive Predictive Value (PPV): Probability of patients with a true positive result having the condition.
    • Formula: TP / (TP + FP)
  • Negative Predictive Value (NPV): Probability of patients with a true negative result not having the condition.
    • Formula: TN / (TN + FN)

Reference Values

  • Reference values (or reference intervals) are a range of values that are typically observed in healthy individuals.
  • The range may differ based on factors like age, sex and specimen type.
  • Establishing reference intervals usually involves a group of healthy subjects being tested and then identifying the normal range.
  • Factors that can influence reference values include age, sex, genetic background, exposure to environmental factors, sample collection and storage, among others.
  • Reference values are utilized to aid in clinical decision-making.

Sample Problems

  • Presented examples demonstrate how to calculate diagnostic accuracy metrics (sensitivity, specificity, PPV, NPV, overall accuracy) using data from 2x2 truth tables.
  • An example problem highlights the impact of cutoff values for a diagnostic test.

Review Questions

  • Review questions are designed to test your understanding of the topic.

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