Clinical laboratory reports in molecular pathology.
BACKGROUND
Molecular pathology is a rapidly growing area of laboratory medicine in which DNA and RNA are analyzed. The recent introduction of array technology has added another layer of complexity involving massive parallel analysis of multiple genes, transcripts, or proteins.


OBJECTIVE
As molecular technologies are increasingly implemented in clinical settings, it is important to bring uniformity to the way that test results are reported.


METHODS
The College of American Pathologists Molecular Pathology Resource Committee members summarize elements that are already common to virtually all molecular pathology reports, as set forth in the College of American Pathologists checklists used in the laboratory accreditation process. Consensus recommendations are proposed to improve report format and content, and areas of controversy are discussed. Resources are cited that promote use of proper gene nomenclature and that describe methods for reporting mutations, translocations, microsatellite instability, and other genetic alterations related to inherited disease, cancer, identity testing, microbiology, and pharmacogenetics.


CONCLUSIONS
These resources and recommendations provide a framework for composing patient reports to convey molecular test results and their clinical significance to members of the health care team.
Gulley
Margaret L
ML
Department of Pathology, 913 Brinkhous-Bullitt Bldg, University of North Carolina, Chapel Hill, NC 27599-7525, USA. margaret_gulley@med.unc.edu
Braziel
Rita M
RM
Halling
Kevin C
KC
Hsi
Eric D
ED
Kant
Jeffrey A
JA
Nikiforova
Marina N
MN
Nowak
Jan A
JA
Ogino
Shuji
S
Oliveira
Andre
A
Polesky
Herbert F
HF
Silverman
Lawrence
L
Tubbs
Raymond R
RR
Van Deerlin
Vivianna M
VM
Vance
Gail H
GH
Versalovic
James
J
D006801:Humans; D008499:Medical Records / Q000592:standards*; D008967:Molecular Biology; D010338:Pathology, Clinical / Q000379:methods* / Q000592:standards*; D012955:Societies, Medical; D014481:United States