Use of External RNA Controls in Gene Expression Assays - Proposed Guidelines

Clinical and Laboratory Standards Institute documents MM16-P Use of External RNA Controls in Gene Expression Assays; Proposed Guideline provides protocols supporting the use of external RNA controls in micro-array and QRT-PCR based gene expression experiments. This guideline addresses important issues associated with the use of external RNA controls as a too for verification of technical performance and in support of the evaluation of qualitative results for a specific clinical analyte including preparation of control transcripts, design of primers and amplicons, quality control, use in final experimental or clinical test application, and the analysis and interpretation of data obtained. The guideline will facilitate research and clinical laboratories, regulatory agencies, accrediting agencies, reference laboratories, as well as test, micro-array and reagent manufacturers in measuring the performance of expression assays

WARRINGTON Janet;  CORBISIER Philippe;  FEILOTTER Harriet;  HACKETT Joseph;  REID Laura;  SALIT Marc;  WAGAR Elizabeth;  WILLIAMS Mickey;  WOLBER Paul; 

2006-03-31

JRC31108