Guidance for Standards for Parentage Testing Laboratories
The AABB Parentage Testing Standards Program Unit has developed guidance material for "Standards for Parentage Testing Laboratories", 5th edition. This guidance provides examples of implementation and explanations of the intent of specific standards. It focuses on quality issues such as laboratory management, supplier qualification, agreement review, control of equipment and nonconformances, as well as new technical requirements such as controls for testing. Several of the appendices have also been revised to reflect recent methodologies. For example, a new appendix featuring examples of serological equivalents for selected low resolution molecular type has been added.
- Paperback | 148 pages
- 24 Sep 2002
- S Karger Ag
- American Association of Blood Banks
- Basel, Switzerland
- 5th edition
Table of contents
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.