Alshymaa A Ahmed, Alia A El Shahawy, Heba M Kadry, Nora M Said
{"title":"Performance of two multiplex flow cytometric assays for antibody detection in Egyptian patients.","authors":"Alshymaa A Ahmed, Alia A El Shahawy, Heba M Kadry, Nora M Said","doi":"10.4102/ajlm.v12i1.2099","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Autoantibodies are vital biomarkers for the diagnosis, assessment and prognostic determination of various autoimmune disorders.</p><p><strong>Objective: </strong>This study aimed to evaluate the performance of the two AtheNA Multi-Lyte<sup>®</sup> systems for the detection of various autoantibodies.</p><p><strong>Methods: </strong>A total of 105 systemic lupus erythematosus patients, 35 patients with other autoimmune diseases (diseased controls), and 30 healthy volunteers (healthy controls) at Zagazig University Hospitals, Zagazig city, Al Sharqia governorate were tested for anti-double-stranded DNA (anti-dsDNA) antibodies using indirect immunofluorescence (IIF) and the AtheNA Multi-Lyte<sup>®</sup> anti-nuclear antibodies-II system between May 2020 and April 2022. Seventy-five patients with clinically suspected autoimmune vasculitis (AIV) and 25 healthy volunteers were also tested for anti-myeloperoxidase and anti-proteinase 3 antibodies using IIF, the AtheNA Multi-Lyte<sup>®</sup> AIV system, and enzyme-linked immunosorbent assay (ELISA).</p><p><strong>Results: </strong>The AtheNA anti-dsDNA test (98.5%) was more specific than IIF (96.9%) for diagnosing systemic lupus erythematosus, but both tests had the same sensitivity (38.1%). Combining both methods increased sensitivity to 47.6%, while increasing the cut-off of the AtheNA anti-dsDNA test to 134 international units/mL increased specificity to 100%. The AtheNA Multi-Lyte AIV system exhibited substantial agreement with IIF regarding anti-myeloperoxidase testing (κ = 0.65) and almost perfect agreement with ELISA (κ = 0.85). The AtheNA Multi-Lyte<sup>®</sup> AIV system exhibited perfect agreement with IIF (κ = 1) and substantial agreement with ELISA for anti-proteinase 3 testing (κ = 0.63).</p><p><strong>Conclusion: </strong>AtheNA Multi-Lyte<sup>®</sup> systems appear to be reliable for anti-dsDNA, anti-myeloperoxidase, and anti-proteinase 3 screening and may be an optimal choice for monitoring anti-dsDNA levels.</p><p><strong>What this study adds: </strong>It is necessary to evaluate various autoantibodies detection assays to increase both sensitivity and specificity of autoimmune diseases diagnostic approaches. AtheNA Multi-Lyte<sup>®</sup> systems appear to be reliable for anti-dsDNA, anti-myeloperoxidase, and anti-proteinase 3 screening and may be an optimal choice for monitoring anti-dsDNA levels.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"12 1","pages":"2099"},"PeriodicalIF":1.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10244819/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"African Journal of Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4102/ajlm.v12i1.2099","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Autoantibodies are vital biomarkers for the diagnosis, assessment and prognostic determination of various autoimmune disorders.
Objective: This study aimed to evaluate the performance of the two AtheNA Multi-Lyte® systems for the detection of various autoantibodies.
Methods: A total of 105 systemic lupus erythematosus patients, 35 patients with other autoimmune diseases (diseased controls), and 30 healthy volunteers (healthy controls) at Zagazig University Hospitals, Zagazig city, Al Sharqia governorate were tested for anti-double-stranded DNA (anti-dsDNA) antibodies using indirect immunofluorescence (IIF) and the AtheNA Multi-Lyte® anti-nuclear antibodies-II system between May 2020 and April 2022. Seventy-five patients with clinically suspected autoimmune vasculitis (AIV) and 25 healthy volunteers were also tested for anti-myeloperoxidase and anti-proteinase 3 antibodies using IIF, the AtheNA Multi-Lyte® AIV system, and enzyme-linked immunosorbent assay (ELISA).
Results: The AtheNA anti-dsDNA test (98.5%) was more specific than IIF (96.9%) for diagnosing systemic lupus erythematosus, but both tests had the same sensitivity (38.1%). Combining both methods increased sensitivity to 47.6%, while increasing the cut-off of the AtheNA anti-dsDNA test to 134 international units/mL increased specificity to 100%. The AtheNA Multi-Lyte AIV system exhibited substantial agreement with IIF regarding anti-myeloperoxidase testing (κ = 0.65) and almost perfect agreement with ELISA (κ = 0.85). The AtheNA Multi-Lyte® AIV system exhibited perfect agreement with IIF (κ = 1) and substantial agreement with ELISA for anti-proteinase 3 testing (κ = 0.63).
Conclusion: AtheNA Multi-Lyte® systems appear to be reliable for anti-dsDNA, anti-myeloperoxidase, and anti-proteinase 3 screening and may be an optimal choice for monitoring anti-dsDNA levels.
What this study adds: It is necessary to evaluate various autoantibodies detection assays to increase both sensitivity and specificity of autoimmune diseases diagnostic approaches. AtheNA Multi-Lyte® systems appear to be reliable for anti-dsDNA, anti-myeloperoxidase, and anti-proteinase 3 screening and may be an optimal choice for monitoring anti-dsDNA levels.
期刊介绍:
The African Journal of Laboratory Medicine, the official journal of ASLM, focuses on the role of the laboratory and its professionals in the clinical and public healthcare sectors,and is specifically based on an African frame of reference. Emphasis is on all aspects that promote and contribute to the laboratory medicine practices of Africa. This includes, amongst others: laboratories, biomedical scientists and clinicians, medical community, public health officials and policy makers, laboratory systems and policies (translation of laboratory knowledge, practices and technologies in clinical care), interfaces of laboratory with medical science, laboratory-based epidemiology, laboratory investigations, evidence-based effectiveness in real world (actual) settings.