Guidance for Standards for Parentage Testing Laboratories

Organization; resources; equipment; supplier and customer issues; process control; documents and records; deviations and nonconforming products and services; assessments - internal and external; process improvement; facilities and safety; clarification process; variance process; complete listing of WHO-recognize HLA-A, B serologic equivalents for selected low resolution molecular types; the sigma value; reported band sizes of k562 with Hae III and Pst I at selected loci; consensus phenotypes for different "positive control" DNA samples used for PCR/STR and RFLP analysis methods; the delta value; numeric statements of the strength of the genetic evidence; formulas for paternity index and RMNE values for simple codominant systems; calculation of the paternity index for the HLA system; kinship analysis; mutation rates summarized for genetic markers analyzed by RFLP mapping; apparent mutations summarized for genetic markers analyzed by PCR; repeat characteristics for PCR/STR mutations; the effect of an isolated single-locus inconsistency in the statistical evaluation of paternity; 95 percent confidence limits for various selected frequencies of observation based upon sample sales.