CLIA Testing Procedures & Method Validation 3

Question 1

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

Accepted Answer

Measure only the intended analyte without interference from other substances

Answer

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

Question 2

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

Accepted Answer

EP05

Answer

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

Question 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:

Accepted Answer

Constant systematic error

Answer

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

Question 4

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

Accepted Answer

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

Answer

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

Question 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?

Accepted Answer

Reject the method and investigate sources of error before patient use

Answer

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.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

CLIA Testing Procedures & Method Validation 3