Lab Med Qual Assur.  2022 Mar;44(1):21-28. 10.15263/jlmqa.2022.44.1.21.

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

• Lee J
• Kim DS
• Park J

• KMID: 2527801
• DOI: http://doi.org/10.15263/jlmqa.2022.44.1.21

Abstract

Autoantibodies to nuclear antigens (antinuclear antibodies, ANAs), doublestranded 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.

Keyword

Standardization; External quality assessment; Autoimmune diseases; Indirect immunofluorescent assay; Antinuclear antibody; AntidsDNA; Anti-extractable nuclear antigen