Clinical Chemistry Link to Randox Laboratories Web Site
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

Clinical Chemistry 49: 717-718, 2003; 10.1373/49.5.717
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Submit an electronic Letter to
the Editor about this paper
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via ISI Web of Science (6)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Richards, C. S.
Right arrow Articles by Grody, W. W.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Richards, C. S.
Right arrow Articles by Grody, W. W.
Related Collections
Right arrow Molecular Diagnostics and Genetics
Right arrow Laboratory Management
(Clinical Chemistry. 2003;49:717-718.)
© 2003 American Association for Clinical Chemistry, Inc.

Editorial

Alternative Approaches to Proficiency Testing in Molecular Genetics

C. Sue Richards1,a and Wayne W. Grody2

1 Department of Molecular and Human Genetics, Baylor College of Medicine, One Baylor Plaza, T526, Houston, TX 77030

2 Divisions of Medical Genetics and Molecular Pathology, UCLA School of Medicine, 10833 Le Conte Ave., Los Angeles, CA 90095-1732

aAuthor for correspondence. Fax 713-798-6182; e-mail carolynr@bcm.tmc.edu.

The first 20% of the full text of this article appears below.

Clinical genetic testing laboratories have come under scrutiny in the US and Europe with increasing public awareness of genomic research. Such increased publicly driven demand for quality can improve laboratories and encourage high standards of excellence. The Department of Health and Human Services Secretary’s Advisory Committee on Genetic Testing (1) was instrumental in placing genetic testing in the public eye and exerted pressure on genetic providers to organize our profession and address public concerns, particularly concerns about laboratory quality.

Are safeguards in place to prevent poor-quality genetic testing? Multiple federal and state agencies as well as professional organizations have developed guidelines, recommendations, and checklists with which laboratories must comply. In the US these include the Clinical Laboratory Improvement Amendments (CLIA) of 1988 (2), Genetic Testing Under the Clinical Laboratory Improvement Amendments (3), New York State Department of Health Laboratory Standards (4), the College of American Pathologists (CAP) checklist for molecular pathology laboratories (5), the American College of Medical Genetics (ACMG) Standards and Guidelines for Clinical Genetics Laboratories (6), and a NCCLS guideline (7). A recent review of quality assurance in genetic testing has been addressed in the ACCE [analytical validity, clinical validity, clinical utility, and ELSI (ethical, legal, and social issues of genetic testing)] report on carrier screening for cystic fibrosis, a CDC-sponsored project (8).

Internal and external quality assurance and quality-control programs have been established to ensure that laboratories can reliably produce (and reproduce) high-quality results in a timely manner and with clinical utility for patients and healthcare providers. Proficiency testing (PT) identifies weaknesses and provides guidance for improvement. The ACMG/CAP PT program has been providing a molecular genetics laboratory survey with challenges on multiple genetic . . . [Full Text of this Article]




The following articles in journals at HighWire Press have cited this article:


Home page
 Clin. Chem.Home page
C. Orlando, P. Verderio, R. Maatman, J. Danneberg, S. Ramsden, M. Neumaier, D. Taruscio, V. Falbo, R. Jansen, C. Casini-Raggi, et al.
EQUAL-qual: A European Program for External Quality Assessment of Genomic DNA Extraction and PCR Amplification
Clin. Chem., July 1, 2007; 53(7): 1349 - 1357.
[Abstract] [Full Text] [PDF]

Home page
 J. Mol. Diagn.Home page
M. Jarvis, R. K. Iyer, L. O. Williams, W. W. Noll, K. Thomas, M. Telatar, and W. W. Grody
A Novel Method for Creating Artificial Mutant Samples for Performance Evaluation and Quality Control in Clinical Molecular Genetics
J. Mol. Diagn., May 1, 2005; 7(2): 247 - 251.
[Abstract] [Full Text] [PDF]

Home page
 J. Mol. Diagn.Home page
W. W. Grody
Quest for Controls in Molecular Genetics
J. Mol. Diagn., November 1, 2003; 5(4): 209 - 211.
[Full Text] [PDF]

Home page
 Clin. Chem.Home page
V. M. Van Deerlin, L. H. Gill, J. M. Farmer, J. Q. Trojanowski, and V. M-Y. Lee
Familial Frontotemporal Dementia: From Gene Discovery to Clinical Molecular Diagnostics
Clin. Chem., October 1, 2003; 49(10): 1717 - 1725.
[Abstract] [Full Text] [PDF]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 2003 by the American Association for Clinical Chemistry.