KMID : 0985420220440010021
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Laboratory Medicine and Quality Assurance 2022 Volume.44 No. 1 p.21 ~ p.28
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A Study of the Standardization and the External Quality Assessment for Antinuclear Antibody, Anti-Double-Stranded DNA, and Anti-Extractable Nuclear Antigen Antibody Testing
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Lee Jae-Hyeon
Kim Dal-Sik Park Joon-Hong
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Abstract
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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.
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KEYWORD
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Standardization, External quality assessment, Autoimmune diseases, Indirect immunofluorescent assay, Antinuclear antibody, Anti-dsDNA, Anti-extractable nuclear antigen
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