analytical range
Concentration span over which a screening assay provides accurate and precise measurements.
Full Definition
The range of analyte concentrations for which a newborn screening test method has been validated to provide reliable, accurate, and precise results. This range must encompass both normal physiologic levels and pathologic concentrations that would trigger follow-up action. Establishing appropriate analytical ranges is crucial for screening program performance, as concentrations outside this range may yield unreliable results. The range is determined through validation studies and must be periodically verified through quality control procedures and proficiency testing.
Usage
Usage note: Distinguish from reference range, which defines normal vs abnormal values.
In Context
- "The analytical range for phenylalanine extends from 30 to 1200 micromoles per liter." — Method validation document
- "Samples exceeding the analytical range require dilution and retesting for accurate quantification." — Laboratory procedure manual