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pISSN 2950-9114 eISSN 2950-9122
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Lab Med Qual Assur 2022; 44(1): 21-28

Published online March 31, 2022


Copyright © Korean Association of External Quality Assessment Service.

A Study of the Standardization and the External Quality Assessment for Antinuclear Antibody, Anti-Double-Stranded DNA, and Anti-Extractable Nuclear Antigen Antibody Testing

Jaehyeon Lee1,2,3,* , Dal Sik Kim1,2,3,* , and Joonhong Park1,2,3

1Department of Laboratory Medicine, Jeonbuk National University Hospital, Jeonbuk National University Medical School; 2Research Institute of Clinical Medicine, Jeonbuk National University; 3Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju, Korea

Correspondence to:Joonhong Park
Department of Laboratory Medicine, Jeonbuk National University Hospital, Jeonbuk National University Medical School, 20 Geonji-ro, Deokjin-gu, Jeonju 54907, Korea
Tel +82-63-250-1218
E-mail miziro@jbnu.ac.kr
*These authors contributed equally to this work and shared the first authorship.

Received: November 22, 2021; Revised: January 12, 2022; Accepted: January 17, 2022

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.


Autoantibodies to nuclear antigens (antinuclear antibodies, ANAs), double-stranded DNA (dsDNA), and extractable nuclear antigens (ENAs) are useful for the early diagnosis and appropriate treatment of autoimmune diseases. This study aimed to investigate autoimmune tests’ standardization and external quality assessment (EQA). To investigate the standardization and operational status of the EQA program for ANA, anti-dsDNA, and anti-ENA antibody testing, online resources were searched, including MEDLINE, PubMed, and Embase. The search terms used were autoimmune disease, ANA, indirect immunofluorescent assay (IIFA), anti-dsDNA, anti-ENA, international consensus/recommendation, or external quality assurance/assessment. Relevant peer-reviewed studies, reviews, and commentaries were also selected. The two reviewers independently assessed data quality, with selection standards based on consensus, recommendations, and assessment criteria. A total of 14 references for standardization (n=8) and EQA (n=6) were selected and provided valuable consensus guidelines for standardization and EQA programs for ANA, anti-dsDNA, and anti-ENA antibody testing. Clinical laboratories should perform IIFA-ANA, anti-dsDNA, and anti-ENA testing based on standard recommendations, actively participate in EQA, and conduct inter-trial tests to verify accuracy, if necessary. Through regular training, medical technicians should be familiar with the principle of the method, reagents, and report results. A laboratory physician should pay attention to the interpretation of results and discuss inconsistent test results with a clinician.

Keywords: Standardization, External quality assessment, Autoimmune diseases, Indirect immunofluorescent assay, Antinuclear antibody, Anti-dsDNA, Anti-extractable nuclear antigen

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