A clinical laboratory is currently developing a new assay for the measurement of naive and memory T cells in pediatric patients. What is the best practice for the laboratory to establish a reliable reference range during validation?
A. Obtain 30 random residual blood samples from any clinical testing and use the results to establish a reference range
B. Obtain 20 blood samples from healthy laboratory staff members and use the results to establish a reference range
C. Define relevant age brackets and stratify at least 20 samples, or ideally, 120 samples, in each of these age ranges to establish age-specific reference ranges
D. Utilize reference ranges from published literature
