CLIA Testing Procedures & Method Validation 5

Question 1

Which of the following best defines the 'analytical measurement range' (AMR) of a quantitative laboratory test?

Accepted Answer

The span of analyte concentrations over which the method produces accurate, linear results without dilution or concentration

Answer

The AMR is the range of concentrations over which a method can directly report accurate results without sample manipulation such as dilution.

Question 2

A new immunoassay for thyroid-stimulating hormone (TSH) shows excellent precision but consistently underestimates TSH in patients with high heterophile antibody titers. This is an example of:

Accepted Answer

Endogenous interference

Answer

Heterophile antibodies are endogenous interferents that can disrupt immunoassay signal, leading to falsely low or high results despite good precision.

Question 3

Under CLIA, which of the following personnel may NOT serve as the technical consultant for a moderate-complexity laboratory?

Accepted Answer

A high school graduate with 5 years of bench experience

Answer

CLIA requires a technical consultant for moderate-complexity labs to have at minimum an associate degree in laboratory science or equivalent, not just bench experience.

Question 4

When a manufacturer's package insert claims a clinical sensitivity of 95% for a disease marker, this means:

Accepted Answer

95% of individuals with the disease test positive

Answer

Clinical sensitivity is the proportion of truly diseased individuals who test positive (true positive rate), not to be confused with analytical sensitivity.

Question 5

During sigma metric analysis for a glucose method, a laboratory calculates: TEa = 10%, bias = 2%, CV = 2%. What is the sigma value?

Accepted Answer

4

Answer

Sigma = (TEa − |bias|) / CV = (10 − 2) / 2 = 4; a sigma of 4 indicates good method performance.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

CLIA Testing Procedures & Method Validation 5