Where can I find more detailed protocols and statistical guidelines for method validation experiments?
The National Committee for Clinical Laboratory Standards (NCCLS, 90 West Valley Road, Suite 1400, Wayne, PA 19087-1898, phone 610-688-0100) provides a series of documents that provide extensive information about individual experiments: • EP5-A. Evaluation of precision performance of clinical chemistry devices. • EP6-P. Evaluation of the linearity of quantitative analytical methods. • EP7-P. Interference testing in clinical chemistry. • EP9-A. Method comparison and bias estimation using patient samples. • EP10-A. Preliminary evaluation of quantitative clinical laboratory methods. • EP14-P. Evaluation of matrix effects. • EP15-P. User demonstration of performance for precision and accuracy. • C28-A. How to define and determine reference intervals in the clinical laboratory.
