I/LA02-A Quality Assurance for the Indirect Immunofluorescence Test for Autoantibodies to Nuclear

36 Pages·00.41 MB·English

I/LA2-A
Vol. 16 No. 11
Replaces I/LA2-T
December 1996 Vol. 13 No. 3
Quality Assurance for the Indirect Immunofluorescence Test for
Autoantibodies to Nuclear Antigen (IF-ANA); Approved Guideline
This document addresses the criteria for immunofluorescence ANA testing, including test components,
quantification of results, and classification criteria.
ABC
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December 1996 I/LA2-A
Quality Assurance for the Indirect Immunofluorescence Test for
Autoantibodies to Nuclear Antigen (IF-ANA); Approved Guideline
Abstract
Quality Assurance for the Indirect Immunofluorescence Test for Autoantibodies to Nuclear Antigen (IF-
ANA); Approved Guideline (NCCLS document I/LA2-A) provides guidance for laboratorians who perform
immunofluorescence tests for autoantibodies to nuclear antigen to detect diseases. Topics addressed
include substrate and fixative variations, fluorescence-labeled conjugates, reference intervals, test results,
and criteria for classification of systemic lupus erythematosus.
[NCCLS. Quality Assurance for the Indirect Immunofluorescence Test for Autoantibodies to Nuclear
Antigen (IF-ANA); Approved Guideline. NCCLS document I/LA2-A (ISBN 1-56238-311-6). NCCLS, 940
West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1996.]
THE NCCLS consensus process, which is the mechanism for moving a document through two
or more levels of review by the patient testing community, is an ongoing process. Users
should expect revised editions of any given document. Because rapid changes in technology
may affect the procedures, bench and reference methods, and evaluation protocols used in
testing, users should replace outdated editions with the current editions of NCCLS documents.
Current editions are listed in the NCCLS Catalog, which is distributed to member organizations,
or to nonmembers on request. If your organization is not a member and would like to become
one, or to request a copy of the NCCLS Catalog, contact the NCCLS Executive Offices.
Telephone: [phone]; Fax: [phone].
NCCLS VOL. 16 NO. 11 i
I/LA2-A
ISBN 1-56238-311-6
December 1996 ISSN 0273-3099
Quality Assurance for the Indirect Immunofluorescence Test for
Autoantibodies to Nuclear Antigen (IF-ANA); Approved Guideline
Volume 16 Number 11
Robert M. Nakamura, M.D.
Linda Ivor
W. Harry Hannon, Ph.D.
A. Myron Johnson, M.D.
J. Mehsen Joseph, Ph.D.
Robert F. Ritchie, M.D.
Donald R. Tourville, Ph.D.
Daniel Tripodi, Ph.D.
S.K. Vadlamudi, D.V.M., Ph.D.

ABC
December 1996 I/LA2-A
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Reproduced with permission, from NCCLS publication I/LA2-A, Quality Assurance for the Indirect
Immunofluorescence Test for Autoantibodies to Nuclear Antigen (IF-ANA); Approved Guideline.
Copies of the current edition may be obtained from NCCLS, 940 West Valley Road, Suite 1400,
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Copyright ©1996. The National Committee for Clinical Laboratory Standards.
Suggested Citation
[NCCLS. Quality Assurance for the Indirect Immunofluorescence Test for Autoantibodies to Nuclear
Antigen (IF-ANA); Approved Guideline. NCCLS document I/LA2-A (ISBN 1-56238-311-6). NCCLS, 940
West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1996.]
Proposed Guideline
August 1986
Tentative Guideline
April 1993
Approved Guideline
December 1996
ISBN 1-56238-311-6
ISSN 0273-3099
NCCLS VOL. 16 NO. 11 iii
December 1996 I/LA2-A
Committee Membership
Area Committee on Immunology and Ligand Assay
Robert M. Nakamura, M.D., Scripps Clinic and Research Foundation
Chairholder La Jolla, California
Linda Ivor Del Mar, California
Vice Chairholder
W. Harry Hannon, Ph.D. Centers for Disease Control and Prevention
Atlanta, Georgia
A. Myron Johnson, M.D. Moses H. Cone Memorial Hospital
Greensboro, North Carolina
J. Mehsen Joseph, Ph.D. Maryland Department of Health & Mental Hygiene
Baltimore, Maryland
Robert F. Ritchie, M.D. Foundation for Blood Research
Scarborough, Maine
Donald R. Tourville, Ph.D. Zeus Scientific, Inc.
Raritan, New Jersey
Daniel Tripodi, Ph.D. Lebanon, New Jersey
S.K. Vadlamudi, D.V.M., Ph.D. Food and Drug Administration
Rockville, Maryland
Advisors
Kaiser J. Aziz, Ph.D. Food and Drug Administration
Rockville, Maryland
Jesse Edwards, Ph.D. National Institute for Standards and Technology
Gaithersburg, Maryland
Marvin L. Goldsmith Beckman Instruments
Brea, California
Tadashi Kawai, M.D. Jichi Medical School
Kawachi, Tochigi, Japan
James McBride, Ph.D. UCLA Medical Center
Los Angeles, California
Thomas A. O'Brien, Ph.D. Raritan, New Jersey
Jerry W. Smith, Ph.D. Difco Laboratories
Ann Arbor, Michigan
Robert W. Veltri, Ph.D. Cytodiagnostics, Inc.
Oklahoma City, Oklahoma
NCCLS VOL. 16 NO. 11 iv
December 1996 I/LA2-A
Leonard Wilson Food and Drug Administration
Bethesda, Maryland
Helen M. Free, D.Sc. Bayer Corporation
Board Liaison Elkhart, Indiana
Denise M. Lynch, M.T.(ASCP) NCCLS
Staff Liaison Wayne, Pennsylvania
Patrice E. Polgar NCCLS
Editor Wayne, Pennsylvania
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December 1996 I/LA2-A
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