Question

14. Additional validation experiments that must be done for Laboratory Developed Tests but are NOT required for FDA approved tests include (more than one answer may be correct) a. Analytic sensitivity b. Analytic specificity c. Calibration and control procedures d. Precision 15. A difference between the Analytical Measurement Range (AMR) and the Reportable Range (R R) is Validation of the AMR requires testing but the RR can be defined by the laboratory director w testing b. a. The RR may include concentrations above the AMR that can be reported using dilution to bring results for a specimen outside of the linearity of the method into the AMR (the RR extends the AMR) The RR is typically narrower (encompasses a smaller concentration range) than the AMR d. The AMR requires validation of dilution accuracy but the RR does not c. 16. The lower limit of quantitation (LLoQ) is a. The highest concentration that is observed from running a blank sample b. The lowest concentration that can reproducibly be distinguished from zero c. The lowest concentration that can reproducibly be quantified with accuracy (often using a threshold of CV <20%) d. The highest concentration that can reproducibly be quantified with accuracy without sample treatment (i.e. dilution)

Answer 1

14) A and B. Laboratories are not required to verify analytical sensitivity or analytical specificity for FDA-approved

15) B. Reportable range includes AMR and clinically reportable range, which can be wider than AMR.

16) C. Limit of Quantification is the lower limit of an analyte that can be reported with acceptable accuracy and precision