Course Lesson
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1. Introduction to qualitative tests quality control
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- In this lesson, we introduce evidence-based medicine into laboratory logic.
- Briefly discusses the importance of regulating in vitro diagnostic (IVD) medical devices for confidence in laboratory results.
Objectives:
- Review the evidence-based laboratory medicine
- Recognize standardization and good practices importance
- Understand "Emergency Use Only" validation principles
- Recognize in vitro diagnostic (IVD) medical devices regulation
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2. Principles and guidelines
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- In this lesson, you will learn the principles behind QC.
- We will review some of the major milestones in laboratory quality control over time.
- Briefly discusses the importance of the dynamics of quality cycles and associated practices.
- Introduces harmonized vocabularies to the medical laboratory.
- Finally, discuss some of the most important QC guides.
Objectives:
- Interpretation difference between GMP and GLP
- Learn the PDCA and TQM principles
- Demystifying the differences between selection, validation, and verification
- Introduction to the guidelines
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3. ISO compliance
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- In this lesson, you will learn which ISO 15189 and ISO 9001 requirements are applicable in the QC of qualitative tests.
- Primary introduction to ISO 15189 global guideline focused on selection, validation, and verification of qualitative med lab tests.
- Interpretation of ISO 9001 in fulfilling technical requirements in qualitative tests.
- Some myths associated with ISO standards and their application in the medical laboratory will be discussed.
Objectives:
- Identify ISO requirements for laboratory tests
- Demystifying some ISO pseudo-assumptions
- Learn which harmonized QC practices are consistent with meeting these requirements
- Know how to relate fit for purpose of results and technical requirements
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4. Causes of uncertainty in qualitative tests
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- In this lesson, you will learn the principal sources of error that can cause untrue binary results
- The impact of the analytical error on the cutoff trueness is discussed, as well as the effect of the analytical error on the accuracy of the classification of binary results
- The importance of the “gray zone” and the associated trinary classification to minimize the impact of analytical error in the results is debated
Objectives:
- Learn what are the most significant causes of uncertainty
- Interpretation of analytical uncertainty components
- Know how the analytical sensitivity and analytical specificity in NAAT
- Identify biological uncertainty components
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5. Sampling principles
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- In this lesson, you will learn the pro and cons of sampling
- Introduction to the epidemiological prevalence
- Techniques for collecting statistically and clinically representative samples
Objectives:
- Recognize the importance of the representativeness of the samples (fit for purpose)
- Know which are the best samples of individuals with and without a particular condition
- Know the importance of the sampling dimensions for the confidence interval estimates
- Recognize the critical role of samples for the robustness and reliability of estimates
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6. Performance of binary classification tests
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- In this lesson, we move to the discussion and application of models for calculating the accuracy of the condition, such as diagnostic accuracy
- We will focus on clinical sensitivity and clinical specificity
- However, we will also discuss the physician's perspective through predictive values
- The importance of the confidence interval will also be discussed. We explore misevaluations implications
Objectives:
- Learn how to calculate and interpret clinical sensitivity and clinical specificity
- Understand the limitations of estimates with poorly representative samples of the population
- Identify the importance of computing the confidence interval
- Understand how to assess the uncertainty of binary results
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7. Agreement of binary classification tests
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- In this lesson, we concentrate on the computation of binary results agreement
- The determination should only occur when it is not possible to calculate the condition's accuracy
- The misinterpretation can lead to weakly sustained decisions. For example, when referring to "clinical sensitivity" in real cases of agreement of positive results
Objectives:
- Know how to calculate and interpret concordances
- Recognize the limitations of this approach
- Recognize the importance of performance to comparative testing for a lower risk of misestimation
- Know how to interpret the confidence interval
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8. Condition accuracy by analyzing numerical data
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- In this lesson, you learn the importance of delta value assessment to differentiate mainly tests with identical clinical accuracy
- The delta value is associated with different levels of misclassification risk of binary results
Objectives:
- Learn when delta evaluation is important for binary results
- Know how to interpret the positive delta
- Know how to interpret the negative delta
- Assess the risk of false results in a series of qualitative tests
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9. Seronegative window period
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- In this lesson, we introduce the seroconversion window period using a binary and trinary results logic
- Recognize the seroconversion period as a primary source of biological bias
Objectives:
- Identify the pros and limitations of this approach
- Evaluate the seroconversion period with binary results
- Assess the seroconversion period with trinary results
- Characterize laboratory methods generations based on the window period
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10. Limit of detection in nucleic acid amplification tests
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- In this lesson, we introduce the evaluation of the limit of detection in nucleic acid amplification tests (NAAT).
- The statistical models are based on logit regression, probit regression, and hit rate.
Objectives:
- Learn the methodology for estimating the limit of detection in NAAT
- Introduction to logit regression, probit regression, and hi-rate
- Know how to determine the limit of detection through probit regression
- Know how to evaluate the detection limit
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