학술논문

Evaluation of the clinical utility of disease-specific antinuclear antibody screening tests using chemiluminescence enzyme immunoassay for routine antinuclear antibody testing / 化学発光酵素免疫測定法を用いた疾患特異的抗核抗体スクリーニング検査の日常診療における有用性の検討
Document Type
Journal Article
Source
医学検査 / Japanese Journal of Medical Technology. 2021, 70(4):661
Subject
anti-DFS70 antibodies
antinuclear antibody
chemiluminescence enzyme immunoassay (CLEIA)
disease-specific antinuclear antibody
screening
スクリーニング
化学発光酵素免疫測定法(CLEIA法)
抗DFS70抗体
抗核抗体
疾患特異的抗核抗体
Language
Japanese
ISSN
0915-8669
2188-5346
Abstract
The antinuclear antibody (ANA) test is clinically important for the diagnosis of autoimmune diseases such as connective tissue diseases and autoimmune hepatitis. The aim of this study was to evaluate the clinical utility of a screening test for eight disease-specific ANAs using a chemiluminescence enzyme immunoassay (CLEIA-ANA) in routine ANA tests and comparing the results with those of an indirect immunofluorescence assay (IF-ANA). In this study, we analyzed patients with rheumatic, dermatological, and gastrointestinal diseases because ANA tests are clinically important for these disorders. The concordance rate between CLEIA-ANA and IF-ANA (1:40) was low (41.9%) in patients with gastrointestinal diseases, suggesting that autoantibodies detected by IF-ANA alone were clinically important. The concordance rates between CLEIA-ANA and IF-ANA (1:160) were 72.8% in patients with rheumatic diseases and 77.5% in patients with dermatological diseases. CLEIA-ANA efficiently detects eight disease-specific ANAs including anti-SS-A antibody, which is frequently overlooked in patients with rheumatic and dermatological diseases when using IF-ANA. The positivity rate for a dense fine speckled (DFS) staining pattern in sera from CLEIA-ANA-negative/IF-ANA-positive patients (1:160) was significantly higher in patients with dermatological diseases (17/45) than in those with rheumatic diseases (5/40) (p = 0.0123). Of 17 patients with dermatological diseases with a DFS staining pattern, 16 were positive for the anti-DFS70 antibody, which is frequently detected in those with skin diseases and in healthy subjects. Indeed, more than half of the 16 patients had a skin disease. In summary, CLEIA-ANA efficiently detects eight disease-specific ANAs in routine ANA tests of patients with rheumatic and dermatological diseases, although in some other patients, such as those with gastrointestinal diseases, they are undetectable by CLEIA-ANA owing to solid-phase antigens.