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Evaluation of the Abbott Alinity i Thyroid-Stimulating Hormone Receptor Antibody (TRAb) Chemiluminescent Microparticle Immunoassay (CMIA)
Background: We evaluated the performance of the Abbott thyroid-stimulating hormone receptor antibody chemiluminescent microparticle immunoassay (CMIA) on the Alinity i. Methods: Verification studies for precision, linearity, analytical measuring range, diagnostic cut offs for Graves’ disease were pe...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10453821/ https://www.ncbi.nlm.nih.gov/pubmed/37627966 http://dx.doi.org/10.3390/diagnostics13162707 |
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author | Lee, Deborah J. W. Phua, Soon Kieng Liang, Yali Chen, Claire Aw, Tar-Choon |
author_facet | Lee, Deborah J. W. Phua, Soon Kieng Liang, Yali Chen, Claire Aw, Tar-Choon |
author_sort | Lee, Deborah J. W. |
collection | PubMed |
description | Background: We evaluated the performance of the Abbott thyroid-stimulating hormone receptor antibody chemiluminescent microparticle immunoassay (CMIA) on the Alinity i. Methods: Verification studies for precision, linearity, analytical measuring range, diagnostic cut offs for Graves’ disease were performed. We compared the Abbott CMIA to an established TRAb assay (Roche electrochemiluminescence immunoassay). Method comparison analysis was performed between serum and plasma samples on the Abbott CMIA. Results: Repeatability (CV%) for TRAb were 4.07, 1.56, 0.71 and within-laboratory imprecision (CV%) were 4.07, 1.90, 0.71 at 3.0, 10.0, 30.0 IU/L of TRAb, respectively. Linearity and analytical measuring range were verified from 1.07–47.9 IU/L. The limit of the blank was 0 IU/L, limit of detection was 0.15 IU/L, and limit of quantification was 0.5 IU/L. Passing-Bablok analysis showed agreement between the two assays; Y-intercept = 0.787, slope = 1.04. Passing-Bablok analysis also showed agreement between the plasma and serum samples run on the Abbott CMIA; Y-intercept −0.17, slope = 0.97. Conclusions: The Abbott TRAb CMIA on the Alinity i performs within the manufacturer claims for assay precision, linearity, analytical measuring range, limit of blank, limit of detection, limit of quantitation and diagnostic cut offs for Graves’ disease. Thus, the Abbott TRAb CMIA on the Alinity i is fit for clinical use. |
format | Online Article Text |
id | pubmed-10453821 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-104538212023-08-26 Evaluation of the Abbott Alinity i Thyroid-Stimulating Hormone Receptor Antibody (TRAb) Chemiluminescent Microparticle Immunoassay (CMIA) Lee, Deborah J. W. Phua, Soon Kieng Liang, Yali Chen, Claire Aw, Tar-Choon Diagnostics (Basel) Brief Report Background: We evaluated the performance of the Abbott thyroid-stimulating hormone receptor antibody chemiluminescent microparticle immunoassay (CMIA) on the Alinity i. Methods: Verification studies for precision, linearity, analytical measuring range, diagnostic cut offs for Graves’ disease were performed. We compared the Abbott CMIA to an established TRAb assay (Roche electrochemiluminescence immunoassay). Method comparison analysis was performed between serum and plasma samples on the Abbott CMIA. Results: Repeatability (CV%) for TRAb were 4.07, 1.56, 0.71 and within-laboratory imprecision (CV%) were 4.07, 1.90, 0.71 at 3.0, 10.0, 30.0 IU/L of TRAb, respectively. Linearity and analytical measuring range were verified from 1.07–47.9 IU/L. The limit of the blank was 0 IU/L, limit of detection was 0.15 IU/L, and limit of quantification was 0.5 IU/L. Passing-Bablok analysis showed agreement between the two assays; Y-intercept = 0.787, slope = 1.04. Passing-Bablok analysis also showed agreement between the plasma and serum samples run on the Abbott CMIA; Y-intercept −0.17, slope = 0.97. Conclusions: The Abbott TRAb CMIA on the Alinity i performs within the manufacturer claims for assay precision, linearity, analytical measuring range, limit of blank, limit of detection, limit of quantitation and diagnostic cut offs for Graves’ disease. Thus, the Abbott TRAb CMIA on the Alinity i is fit for clinical use. MDPI 2023-08-19 /pmc/articles/PMC10453821/ /pubmed/37627966 http://dx.doi.org/10.3390/diagnostics13162707 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Brief Report Lee, Deborah J. W. Phua, Soon Kieng Liang, Yali Chen, Claire Aw, Tar-Choon Evaluation of the Abbott Alinity i Thyroid-Stimulating Hormone Receptor Antibody (TRAb) Chemiluminescent Microparticle Immunoassay (CMIA) |
title | Evaluation of the Abbott Alinity i Thyroid-Stimulating Hormone Receptor Antibody (TRAb) Chemiluminescent Microparticle Immunoassay (CMIA) |
title_full | Evaluation of the Abbott Alinity i Thyroid-Stimulating Hormone Receptor Antibody (TRAb) Chemiluminescent Microparticle Immunoassay (CMIA) |
title_fullStr | Evaluation of the Abbott Alinity i Thyroid-Stimulating Hormone Receptor Antibody (TRAb) Chemiluminescent Microparticle Immunoassay (CMIA) |
title_full_unstemmed | Evaluation of the Abbott Alinity i Thyroid-Stimulating Hormone Receptor Antibody (TRAb) Chemiluminescent Microparticle Immunoassay (CMIA) |
title_short | Evaluation of the Abbott Alinity i Thyroid-Stimulating Hormone Receptor Antibody (TRAb) Chemiluminescent Microparticle Immunoassay (CMIA) |
title_sort | evaluation of the abbott alinity i thyroid-stimulating hormone receptor antibody (trab) chemiluminescent microparticle immunoassay (cmia) |
topic | Brief Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10453821/ https://www.ncbi.nlm.nih.gov/pubmed/37627966 http://dx.doi.org/10.3390/diagnostics13162707 |
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