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CLSI Guideline Provides Protocols for the use of RNA Controls in Gene Expression Assays

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Microarray and QRT-PCR technologies are emerging as vital components of genomic, evidence-based medicine.

Standard controls are required to ensure reliability and quality from these assay platforms before microarray and QRT-PCR results are accepted for clinical applications.

The ability to report reliable gene expression results of known quality is key to the employment of microarrays and QRT-PCR as tools in toxicogenomics, pharmacogenetics, pharmacogenomics, and as diagnostic devices in clinical medicine.

In response to this need, Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published Use of External RNA Controls in Gene Expression Assays; Approved Guideline (MM16-A), which provides a set of agreed-upon protocols supporting the use of external RNA controls in microarray- and QRT-PCR-based gene expression experiments.

This guideline addresses important issues associated with the use of external RNA controls as a tool for verification of technical performance.

In addition, it supports 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,

- analysis and interpretation of data obtained.

This document is intended to help ensure comparable within-platform assay performance to enable comparisons of gene expression results.

The protocols will enable research and clinical laboratories, regulatory agencies, accrediting agencies, reference laboratories, as well as test, microarray, and reagent manufacturers to assess the performance of these expression assays.

MM16-A was developed by CLSI as part of a partnership effort with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).