Developing a sustainable process to provide quality control materials for genetic testing.
OBJECTIVE
To provide a summary of the outcomes of two working conferences organized by the Centers for Disease Control and Prevention (CDC), to develop recommendations for practical, sustainable mechanisms to make quality control (QC) materials available to the genetic testing community.


METHODS
Participants were selected to include experts in genetic testing and molecular diagnostics from professional organizations, government agencies, industry, laboratories, academic institutions, cell repositories, and proficiency testing (PT)/external Quality Assessment (EQA) programs. Current efforts to develop QC materials for genetic tests were reviewed; key issues and areas of need were identified; and workgroups were formed to address each area of need and to formulate recommendations and next steps.


RESULTS
Recommendations were developed toward establishing a sustainable process to improve the availability of appropriate QC materials for genetic testing, with an emphasis on molecular genetic testing as an initial step.


CONCLUSIONS
Improving the availability of appropriate QC materials is of critical importance for assuring the quality of genetic testing, enhancing performance evaluation and PT/EQA programs, and facilitating new test development. To meet the needs of the rapidly expanding capacity of genetic testing in clinical and public health settings, a comprehensive, coordinated program should be developed. A Genetic Testing Quality Control Materials Program has therefore been established by CDC in March 2005 to serve these needs.
Chen
Bin
B
Quality Control Materials for Genetic Testing Group, Centers for Disease Control and Prevention, Atlanta, Georgia 30341, USA.
O' Connell
Catherine D
CD
Boone
D Joe
DJ
Amos
Jean A
JA
Beck
Jeanne C
JC
Chan
Maria M
MM
Farkas
Daniel H
DH
Lebo
Roger V
RV
Richards
Carolyn Sue
CS
Roa
Benjamin B
BB
Silverman
Lawrence M
LM
Barton
David E
DE
Bejjani
Bassem A
BA
Belloni
Dorothy R
DR
Bernacki
Susan H
SH
Caggana
Michele
M
Charache
Patricia
P
Dequeker
Elisabeth
E
Ferreira-Gonzalez
Andrea
A
Friedman
Kenneth J
KJ
Greene
Carol L
CL
Grody
Wayne W
WW
Highsmith
William Edward
WE
Hinkel
Cecelia S
CS
Kalman
Lisa V
LV
Lubin
Ira M
IM
Lyon
Elaine
E
Payne
Deborah A
DA
Pratt
Victoria M
VM
Rohlfs
Elizabeth
E
Rundell
Clark A
CA
Schneider
Erasmus
E
Willey
Ann M
AM
Williams
Laurina O
LO
Willey
James C
JC
Winn-Deen
Emily S
ES
Wolff
Daynna J
DJ
D002487:Centers for Disease Control and Prevention, U.S.; D005820:Genetic Testing / Q000592:standards*; D033161:Government Regulation; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards; D011786:Quality Control; D015203:Reproducibility of Results; D014481:United States