Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Lee, Deborah J. W., Phua, Soon Kieng, Liang, Yali, Chen, Claire, Aw, Tar-Choon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
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
_version_ 1785096036674437120
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
work_keys_str_mv AT leedeborahjw evaluationoftheabbottalinityithyroidstimulatinghormonereceptorantibodytrabchemiluminescentmicroparticleimmunoassaycmia
AT phuasoonkieng evaluationoftheabbottalinityithyroidstimulatinghormonereceptorantibodytrabchemiluminescentmicroparticleimmunoassaycmia
AT liangyali evaluationoftheabbottalinityithyroidstimulatinghormonereceptorantibodytrabchemiluminescentmicroparticleimmunoassaycmia
AT chenclaire evaluationoftheabbottalinityithyroidstimulatinghormonereceptorantibodytrabchemiluminescentmicroparticleimmunoassaycmia
AT awtarchoon evaluationoftheabbottalinityithyroidstimulatinghormonereceptorantibodytrabchemiluminescentmicroparticleimmunoassaycmia