Clinical Laboratory Measurements Traceable to the National
Reference System for Cholesterol
Accurate laboratory measurements of blood lipids and
lipoproteins (including total cholesterol {TC}, low-density
lipoprotein cholesterol, high-density lipoprotein cholesterol, and
triglycerides) are important for diagnosing and managing coronary
heart disease. The medical decision points established by the
National Cholesterol Education Program (NCEP) were determined from
an epidemiologic database standardized by the CDC reference method
(RM) (1). The NCEP recommends that TC measurements made by all
clinical laboratories in the United States be traceable (i.e., have
a documented relation) to this accuracy base. The NCEP established
specific national performance goals for the precision and accuracy
of TC measurements. The goal for intralaboratory precision is less
than or equal to 3% coefficient of variation, and the goal for bias
is less than or equal to 3% from the true value. Laboratories can
achieve the precision guidelines by establishing an active internal
quality-control program. They can achieve the accuracy guidelines
by improving the calibration of analytical systems and by verifying
traceability to the National Reference System for Cholesterol
(NRS/CHOL), of which the CDC RM is an integral part.
To facilitate access to the NRS/CHOL and to provide an
appropriate means for verifying traceability, in 1989, CDC
established the Cholesterol Reference Method Laboratory Network
(CRMLN). Clinical laboratories can evaluate their performance on
fresh samples by completing a comparison with the reference method
in a CRMLN laboratory. Participation is voluntary. The CRMLN
documents successful comparisons with a "Certificate of
Traceability," which is valid for 6 months.
A national health objective for the year 2000 is to increase
to at least 90% the proportion of clinical laboratories that meet
the recommended accuracy standard for TC measurement (objective
15.17) (2). To verify the accuracy of their TC measurements,
laboratories should contact a CRMLN laboratory (Table_1).
Information about how clinical laboratories can participate in the
program and the list of laboratories that have received
Certificates of Traceability will be available beginning March 18,
1994, through the CDC Voice Information System, telephone (404)
332-2592.
Reported by: Special Activities Br, Div of Environmental Health
Laboratory Sciences, National Center for Environmental Health, CDC.
References
National Heart, Lung, and Blood Institute. Recommendations for
improving cholesterol measurement: a report from the Laboratory
Standardization Panel of the National Cholesterol Education
Program. Bethesda, Maryland: US Department of Health and Human
Services, Public Health Service, National Institutes of Health,
1990; publication no. (NIH)90-2964:3-4.
Public Health Service. Healthy people 2000: national health
promotion and disease prevention objectives -- full report, with
commentary. Washington, DC: US Department of Health and Human
Services, Public Health Service, 1991; DHHS publication no.
(PHS)91-50212:112-4.
Table_1 Note:
To print large tables and graphs users may have to change their printer settings to landscape and use a small font size.
TABLE 1. Laboratories participating in the Cholesterol Reference Method Laboratory
Network -- United States and international
UNITED STATES
Pacific Biometrics Research Foundation
State Laboratory of Hygiene 1100 Eastlake Avenue
University of Wisconsin Seattle, WA 98109
Center for Health Sciences G. Russell Warnick, M.S.
465 Henry Mall (206) 233-9151 Phone
Madison, WI 53706 (206) 233-0198 Fax
David Hassemer, M.S.
(608) 833-1770 (ext. 102) Phone INTERNATIONAL
(608) 833-2803 Fax Rotterdam University Hospital
Department of Clinical Chemistry
Pennsylvania State Department of Health Lipid Reference Laboratory
Bureau of Laboratories 3015 GD Rotterdam, THE NETHERLANDS
Division of Chemistry and Toxicology Christa M. Boersma-Cobbaert, Ph.D.
RO. Box 500 31-10-4633493 Phone
Exton, PA 19341-0500 31-10-4367894 Fax
Irene Daza
(215) 363-8500 Phone Center for Adult Diseases, Osaka
(215) 436-3346 Fax Department of Epidemiology
and Mass Examination for CVD
University of Minnesota 3 Nakamichi 1-chome
Department of Laboratory Medicine and Pathology Higashinari-ku
Box 198 UMHC Osaka 537, JAPAN
420 Delaware Street Masakazu Nakamura, Ph.D.
Minneapolis, MN 55455-0392 81-6-972-1181 (ext. 2211) Phone
John H. Eckfeldt, M.D. 81-6-972-7749 Fax
(612) 626-3176 Phone
(612) 625-6994 Fax Institute of Biochemistry
Department of Pathological Biochemistry
Northwest Lipid Research Laboratories Glasgow Royal Infirmary
Core Laboratory 4th Floor Alexandra Parade
2121 N. 35th Street Glasgow G31 2ER, GREAT BRITAIN
Seattle, WA 98103 Chris J. Packard, Ph.D.
Santica Marcovina, Ph.D. 44-41-552-3535 Phone
(206) 685-3331 Phone 44-41-553-2558 Fax
(206) 685-3279 Fax
Canadian Reference Foundation
The Cleveland Clinic Foundation 307-2083 Alma Street
Department of Biochemistry, L-11 Vancouver, British Columbia V6R 4N6, CANADA
9500 Euclid Avenue David W. Seccombe, M.D.
Cleveland, OH 44195 (604) 222-1879 Phone
Joan A. Waletzky (604) 222-0134 Fax
(216) 444-8301 Phone
(216) 444-4414 Fax
UNDERGOING STANDARDIZATION
Wadsworth Center for Laboratories and Research
New York State Department of Health H.S. Raffaele
Empire State Plaza Laboratorio Analisi Cliniche
Albany, NY 12201 Via Olgettina 60
Robert Rej, Ph.D. 30132 Milano, ITALY
(518) 473-0117 Phone Ferruccio Ceriotti, Ph.D.
(518) 474-7992 Fax CERTIOTF%IMIHSRA.BITNET@VM.CNUCE.CNR.IT
011-39-2-2643-2315 (or 2313) Phone
Washington University School of Medicine 011-39-2-2643-2640 Fax
Lipid Research Center
4566 Scott Avenue Centre de Medicine Preventive
St. Louis, MO 63110 Laboratorie de Biologie Clinique
Thomas G. Cole, Ph.D. 2, avenue du Doyen J. Parisot
(314) 362-3522 Phone 54500 Vandowuvre-les-Nancy, FRANCE
(314) 362-7657 Fax Prof. Gerard Siest
Josiane Steinmetz, Ph.D.
USDA Human Nutrition Research Center on Aging 011-33-83-444415 Phone
Tufts University 011-33-83-440361 Fax
711 Washington Street, Room 501
Boston, MA 02111
Judith R. McNamara
(617) 556-3104 Phone
(617) 556-3103 Fax
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