reference range

Full Definition

Reference ranges in newborn screening represent the distribution of analyte concentrations found in healthy newborn populations, used to establish cutoff values that distinguish normal from abnormal results. These ranges are typically age-specific and method-specific, derived from large population studies of unaffected infants. Proper establishment and periodic validation of reference ranges is critical for maintaining appropriate screening sensitivity and specificity while minimizing false positive and false negative results.

Usage

Usage note: Distinguish from cutoff values, which are action thresholds rather than statistical ranges.

In Context

• "The laboratory updated reference ranges based on three years of population data." — Method validation report
• "Age-specific reference ranges improved the accuracy of thyroid screening interpretation." — Clinical study