Practice Test Geeks(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test
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Testing Procedures & Method Validation Flashcards

7 cards from real CLIA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Testing Procedures & Method Validation flashcards as text

  1. In method validation, 'analytical specificity' refers to a method's ability to:

    Answer: Measure only the intended analyte without interference from other substances

    Analytical specificity is the ability of a method to measure solely the target analyte even in the presence of potentially interfering substances.

  2. Which CLSI guideline specifically addresses evaluation of precision of quantitative measurement procedures?

    Answer: EP05

    CLSI EP05 is the guideline for evaluation of precision (repeatability and within-laboratory imprecision) of quantitative measurement procedures.

  3. A laboratory notices that results from a new cholesterol analyzer are consistently 5 mg/dL higher than the reference method across all concentrations. This finding most likely indicates:

    Answer: Constant systematic error

    A fixed offset that remains constant regardless of analyte concentration is classified as constant (systematic) bias.

  4. What does the term 'limit of quantitation' (LoQ) describe in laboratory testing?

    Answer: The lowest concentration that can be measured with acceptable precision and accuracy

    The LoQ is the lowest analyte concentration that can be quantitatively measured with acceptable precision (typically CV ≤20%) and accuracy.

  5. During a method validation for a moderately complex test, a laboratory calculates a total allowable error (TEa) of 10%. The observed total error is 12%. What action is required?

    Answer: Reject the method and investigate sources of error before patient use

    When observed total error exceeds TEa, the method fails validation and must not be used for patient testing until the source of error is identified and corrected.

  6. Which type of QC procedure evaluates performance between different analysts, instruments, or time periods within the same laboratory?

    Answer: Between-run (intermediate) precision

    Between-run (intermediate) precision captures variability across different runs, days, analysts, or instruments within one laboratory.

  7. Under CLIA regulations, the laboratory director must approve which document before a new test is placed into service?

    Answer: The standard operating procedure (SOP)

    CLIA requires the laboratory director to review and approve the standard operating procedure (SOP) before a test is used for patient care.