Regulatory Standards & Compliance Flashcards

How is the limit of detection (LoD) of a PCR assay commonly defined for validation?

Answer: The lowest concentration detected in at least 95% of replicates

LoD is typically the lowest analyte concentration reliably detected in at least 95% of replicate tests.

Which CLSI document gives guidance on evaluating detection capability, including LoB, LoD, and LoQ?

Answer: CLSI EP17

CLSI EP17 covers evaluation of limit of blank, limit of detection, and limit of quantitation.

Under CLIA, how often must the competency of testing personnel be assessed after their first year on the job?

Answer: Annually

Competency is assessed semiannually during the first year and at least annually after that.

A clinical lab uses a kit labeled 'For Research Use Only. Not for use in diagnostic procedures.' to report patient PCR results. What is the compliance issue?

Answer: RUO products are not FDA-cleared for diagnosis, so the lab must fully validate the test as its own and take on that responsibility

RUO products lack FDA clearance for clinical use, so any diagnostic use requires full lab validation and creates regulatory risk.

Which section of the Federal Food, Drug, and Cosmetic Act lets the FDA authorize unapproved diagnostic tests during a declared emergency?

Answer: Section 564 Emergency Use Authorization

Section 564 lets FDA issue EUAs, as it did widely for SARS-CoV-2 PCR tests.

Which federal law prohibits health insurers and employers from discriminating against people based on genetic test results?

Answer: GINA

The Genetic Information Nondiscrimination Act of 2008 protects against genetic discrimination in health insurance and employment.

Under CLIA, a PCR lab's unsuccessful proficiency testing performance usually means which pattern for an analyte?

Answer: Unsatisfactory performance in two consecutive events or two of three consecutive events

Unsuccessful PT is defined as unsatisfactory scores in two consecutive or two of three consecutive testing events.