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Also see General Policies C7, Levels of Development of a Diagnostic Test, and C8, Test Validation, in the ACMG Standards and Guidelines for Clinical Genetics Laboratories, 2008 Edition, revised 02/2007 ( Reference ranges For quantitative metabolite studies, it is recommended that laboratory-specific reference ranges for creatine, guanidinoacetate, and creatinine be determined for each sample type (plasma, urine, and/or CSF), using guidelines as defined by the laboratorys policy and procedure for method validation (e.g., Clinical and Laboratory Standards Institute document EP28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory