Evaluation of the LIA-ANA-Profile-17S for the detection of autoantibodies to nuclear antigens

Ahram Yi; Chang-Hoon Lee; Hee-Won Moon; Hanah Kim; Mina Hur; Yeo-Min Yun

doi:10.1016/j.clinbiochem.2018.03.020

Evaluation of the LIA-ANA-Profile-17S for the detection of autoantibodies to nuclear antigens

Clin Biochem. 2018 May:55:75-79. doi: 10.1016/j.clinbiochem.2018.03.020. Epub 2018 Mar 30.

Authors

Ahram Yi¹, Chang-Hoon Lee¹, Hee-Won Moon², Hanah Kim¹, Mina Hur¹, Yeo-Min Yun¹

Affiliations

¹ Department of Laboratory Medicine, Konkuk University School of Medicine, Konkuk University Medical Center, Seoul, Republic of Korea.
² Department of Laboratory Medicine, Konkuk University School of Medicine, Konkuk University Medical Center, Seoul, Republic of Korea. Electronic address: hannasis@hanmail.net.

PMID: 29608892
DOI: 10.1016/j.clinbiochem.2018.03.020

Abstract

Objectives: The diagnostic tests for autoimmune disease include screening for autoantibodies for nuclear antigens (ANA) and antibodies against extractable nuclear antigens (ENA). Using the line immunoassay (LIA) method, various kinds of ENA antibodies can be detected simultaneously. We evaluated the performance of the newly launched LIA-ANA-Profile-17S (Shenzhen YHLO Biotech, Shenzhen, China) as compared to a conventional LIA kit.

Methods: Residual samples were collected from 200 patients who had been tested for ANA using indirect immunofluorescence. The LIA-ANA-Profile-17S was compared to the EuroLine ANA (Euroimmun, Oberlausitz, Germany) for the analysis of 17 different autoantibodies. The concordance rate and agreement between assays were determined. Samples showing discrepancies between the LIA-ANA-Profile-17S and EuroLine tests were further examined through additional analysis.

Results: The overall agreement was moderate (kappa = 0.759, 95% CI = 0.712-0.805). Agreement between assays ranged from weak to almost perfect, except for those tests targeting nucleosomes, histones, and PM-Scl. Of the 57 disparate results between LIA-ANA-Profile-17S and EuroLine, 38 (66.7%) samples tested positive under an additional assay, showing variable patterns between types of autoantibodies. The positive rate of each autoantibody between LIA-ANA-Profile-17S and EuroLine did not differ significantly, except for anti-nucleosome and anti-histone assays in samples from patients diagnosed with systemic lupus erythematosus (P = 0.004 and 0.001, respectively).

Conclusions: Compared to those from the conventional EuroLine assay, the LIA-ANA-Profile-17S results showed variable agreement in samples showing different prevalence of each autoantibody. The most frequently detected antibodies showed almost perfect agreement. The LIA-ANA-Profile-17S could play a role in the diagnosis of systemic autoimmune disease in ANA-positive samples.

Keywords: ENA; EuroLine; LIA-ANA-profile-17S; Line immunoassay.

Publication types

Clinical Trial

MeSH terms

Adult
Antibodies, Antinuclear / blood*
Autoimmune Diseases / blood*
Female
Humans
Immunoassay / instrumentation
Immunoassay / methods
Male
Middle Aged

Substances

Antibodies, Antinuclear