Sheikh Sajjadieh M, Ajami A, Haghshenas L. Estimation of sensitivity and specificity of antinuclear antibody by automated indirect immunofluorescence and enzyme-linked immunoassay. mljgoums 2024; 18 (4) :22-23
URL:
http://mlj.goums.ac.ir/article-1-1449-en.html
1- Department of Immunology, Nobel Medical Laboratory, Isfahan, Iran , mohammad_esfahan@yahoo.com
2- Department of Immunology, Nobel Medical Laboratory, Isfahan, Iran ; Medical Diagnostic Laboratory of Isfahan Province Health Center, Isfahan University of Medical Science, Isfahan, Iran
3- Department of Clinical Bioinformatics, Harvard Medical School, Boston MA, USA
Abstract: (1157 Views)
Background: Immunofluorescence and serology analysis are the most common laboratory methods for diagnosing antinuclear antibodies in autoimmune diseases and are paramount for screening and therapeutic purposes. This study aims to estimate the sensitivity and specificity of antinuclear antibodies measured by automated indirect immunofluorescence and enzyme-linked immunoassay in patients at risk for autoimmune diseases.
Methods: Serum antinuclear antibodies in 3020 patients suspected of autoimmune diseases at Nobel Medical Laboratory, Esfahan, IRAN, were measured from 2017 until 2020 with automated indirect immunofluorescence and enzyme-linked immune assay methods. The sensitivity, specificity, prevalence, positive and negative predictive value, and likelihood ratio were calculated for each technique. In addition, the receiver operating characteristic curve (ROC) was analysed as a statistical method for assessing the diagnostic accuracy of these tests.
Results: The immunofluorescence method demonstrated low sensitivity and high specificity compared with the enzyme-linked immunoassay. For the automated indirect immunofluorescence method, sensitivity and specificity were 88% and 62%, respectively, whereas this number for the ELISA method was determined as 89.6% and 28.5 %, respectively.
Conclusion: It is crucial to choose a suitable method for detecting autoantibodies for diagnostic purposes. ANA analysis by a sensitive test, such as an enzyme-linked immunoassay, should be used for screening. In contrast, a highly specific test, such as an indirect immunofluorescence assay, should be used to confirm the result and monitor dynamic treatment.
Research Article:
Research Article |
Subject:
Laboratory Sciences Received: 2023/10/10 | Accepted: 2024/02/12 | Published: 2025/03/11 | ePublished: 2025/03/11
References
1. Fava A, Petri M. Systemic lupus erythematosus: Diagnosis and clinical management. J Autoimmun. 2019; 96: 1-13. [
View at Publisher] [
DOI] [
PMID] [
Google Scholar]
2. Aringer M, Petri M. New classification criteria for systemic lupus erythematosus. Curr Opin Rheumatol. 2020; 32(6): 590-596. [
View at Publisher] [
DOI] [
PMID] [
Google Scholar]
3. Jamshidi AR, Tehrani Banihashemi A, Roknsharifi Sh. Estimating the prevalence and disease characteristics of rheumatoid arthritis in Tehran: A WHO -ILAR COPCORD Study (from Iran COPCORD study, Urban Study stage 1). Med J Islam Repub Iran. 2014; 28: 93. [
View at Publisher] [
PMID] [
Google Scholar]
4. Agmon-Levin N, Damoiseaux J, Kallenberg C, Sack U, Witte T. International recommendations for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. Ann Rheum Dis. 2014 ;73:17-23. [
View at Publisher] [
DOI] [
PMID] [
Google Scholar]
5. Orme ME, Andalucia C, Sjölander S, Bossuyt X. A comparison of a fluorescence enzyme immunoassay versus indirect immunofluorescence for initial screening of connective tissue diseases: Systematic literature review and meta-analysis of diagnostic test accuracy studies. Best Pract Res Clin Rheumatol. 2018; 32:521-534. [
View at Publisher] [
DOI] [
PMID] [
Google Scholar]
6. Sumanth Kumar GLS, Chaudhury A, Verma A, Kumar Bhattaram S. Comparison of enzyme linked immunosorbent assay (ELISA) with indirect immunofluorescence for detection of anti-nuclear antibody. The Journal of Clinical and Scientific Research. 2014; 3(4): 237-242. [
Article] [
Google Scholar]
7. Alsaed OS, Alamlih LI, Al-Radideh O, Chandra P, Alemadi S, Al-Allaf AW. Clinical utility of ANA-ELISA vs ANA-immunofluorescence in connective tissue diseases. Sci Rep. 2021; 11(1): 8229. [
View at Publisher] [
DOI] [
PMID] [
Google Scholar]
8. Loock CD, Egerer K, Feist E, Burmester GR. Automated evaluation of ANA under real-life conditions. RMD Open. 2017; 3(1): e000409. [
View at Publisher] [
DOI] [
PMID] [
Google Scholar]