scope:

The use of molecular methods that use deoxyribonucleic acid (DNA) probes in clinical diagnosis presents new challenges to the pathologist. Despite the clear benefits of having another method by which to identify proliferation of monoclonal cell populations, issues of sensitivity and false-positive results mandate the application of stringent laboratory practice. To ensure the success of nucleic acid diagnostics, several key areas warrant attention. This document addresses the following topics as they relate to the direct detection of T- and B-cell gene rearrangements:

• indications for gene rearrangement analysis;

• specimen collection, transport, and processing;

• assessment of specimen adequacy;

• conduct of the gene rearrangement assay;

• sensitivity, specificity, controls, and artifacts;

• quality assurance; and

• interpretation of results.