Dataset Information

Comparison of Three Immunoassays for the Detection of Myositis Specific Antibodies.

ABSTRACT: Objectives: Standardization of myositis specific antibody (MSA) detection is of high importance because these antibodies are relevant for diagnosis and stratification of patients with idiopathic inflammatory myositis (IIM) and have the potential to be used in classification criteria. Many laboratories rely on immunoprecipitation (IP) for the detection of MSA but this approach is compromised by logistic, standardization, and regulatory challenges. Therefore, reliable alternatives to IP are mandatory. Here we aimed to compare three methods for the detection of MSA. Methods: Our study initiated from a cohort of 1,619 IIM patients (BIRD/University of Bath serology service and UKMyoNet cohorts) and resulted in 157 unique serum samples enriched for higher prevalence of MSA characterized by the laboratory's routine methods, IP and line immunoassay (LIA: Euroimmun). All samples were tested using a novel fully automated particle-based multi-analyte technology (PMAT, Inova Diagnostics, research use only). Analyses included antibodies to PL-7, PL-12, SRP, NXP2, Mi-2, SAE, EJ, MDA5, TIF1?, SRP, NXP2. Results: Overall high agreements were observed between novel methods (LIA and PMAT) and IP (Cohen's kappa 0.46-0.96) for the detection of MSA. Lowest level of agreement was found for EJ and highest for SAE. Conclusion: The data hold promise for advancements in standardization of MSA assays as well as for the potential inclusion of MSA in future classification criteria.

SUBMITTER: Mahler M

PROVIDER: S-EPMC6503053 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Comparison of Three Immunoassays for the Detection of Myositis Specific Antibodies.

Mahler Michael M Betteridge Zoe Z Bentow Chelsea C Richards Michaelin M Seaman Andrea A Chinoy Hector H McHugh Neil N

Frontiers in immunology 20190430

<b>Objectives:</b> Standardization of myositis specific antibody (MSA) detection is of high importance because these antibodies are relevant for diagnosis and stratification of patients with idiopathic inflammatory myositis (IIM) and have the potential to be used in classification criteria. Many laboratories rely on immunoprecipitation (IP) for the detection of MSA but this approach is compromised by logistic, standardization, and regulatory challenges. Therefore, reliable alternatives to IP are ...[more]

PMID: 31114570

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Project description:IntroductionCommercially available serological assays for SARS-CoV-2 detect antibodies to either the nucleocapsid or spike protein. Here we compare the performance of the Beckman-Coulter SARS-CoV-2 spike IgG assay to that of the Abbott SARS-CoV-2 nucleocapsid IgG and Roche Anti-SARS-CoV-2 nucleocapsid total antibody assays. In addition, we document the trend in nucleocapsid and spike antibodies in sequential samples collected from convalescent plasma donors.MethodsPlasma or serum samples from 20 individual SARS-CoV-2 RT-PCR-positive inpatients (n = 172), 20 individual convalescent donors with a previous RT-PCR-confirmed SARS-CoV-2 infection (n = 20), were deemed positive SARS-CoV-2 samples. RT-PCR-negative inpatients (n = 24), and 109 pre-SARS-CoV-2 samples were determined to be SARS-CoV-2 negative. Samples were assayed by the Abbott, Roche, and Beckman assays.ResultsAll three assays demonstrated 100% specificity. Abbott, Beckman, and Roche platforms had sensitivities of 98%, 93%, and 90% respectively, with the difference in sensitivity attributed primarily to samples from immunocompromised patients. After the exclusion of samples immunocompromised patients, all assays exhibited ≥ 95% sensitivity. In sequential samples collected from the same individuals, the Roche nucleocapsid antibody assay demonstrated continually increasing signal intensity, with maximal values observed at the last time point examined. In contrast, the Beckman spike IgG antibody signal peaked between 14 and 28 days post positive SARS-CoV-2 PCR and steadily declined in subsequent samples. Subsequent collections 51-200 days (median of 139 days) post positive SARS-CoV-2 RT-PCR from five inpatients and five convalescent donors revealed that spike and nucleocapsid antibodies remained detectable for several months after confirmed infection.ConclusionsThe three assays are sensitive and specific for SARS-CoV-2 antibodies. Nucleocapsid and spike antibodies were detectable for up to 200 days post-positive SARS-CoV-2 PCR but demonstrated markedly different trends in signal intensity.

Project description:BACKGROUND:A myositis-specific autoantibody can now be identified in the majority of patients with myositis. They identify homogeneous patient subgroups and are key tools in developing a personalized approach to disease management. There is substantial clinical interest in exploiting myositis autoantibodies as biomarkers, and consequently, a large number of commercial assays have been developed for their detection. These assays are already in widespread clinical use. In order to better understand perceived concerns from the international myositis community in relation to the reliability of these assays and how they are being used, we conducted a survey of international myositis experts, all of whom were members of the International Myositis Assessment and Clinical Studies group. RESULTS:We collected data on the types of assay used, manufacturers, and the nature of the report provided by different laboratories and received 111 complete responses. Respondents also provided information on how they used the different assays, their confidence in the results, and how this influenced their clinical practice. Enzyme immunoassay/ELISA was the most popular assay method used worldwide followed by line blot. Line blot was the most popular method used in Europe. Despite concerns from over 80% of respondents regarding false-positive and false-negative results with the assay used by their laboratory, over 80% reported that the identification of a myositis autoantibody influenced their diagnostic confidence, the information they provided to a patient, and their recommended treatment. CONCLUSIONS:In spite of ongoing concerns from the majority of users regarding the reliability of the results, myositis-specific autoantibody testing, using commercial immunoassays, is being used globally to inform clinical decision-making. These findings highlight the need for urgent guidance on the use of myositis autoantibody testing and on the interpretation of results. Knowledge of the reliability of currently available assays is essential given the importance already placed on myositis-specific autoantibodies as clinical decision-making tools.

Dataset Information

Comparison of Three Immunoassays for the Detection of Myositis Specific Antibodies.

Publications

Comparison of Three Immunoassays for the Detection of Myositis Specific Antibodies.

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