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Quantification of human C1 esterase inhibitor protein using an automated turbidimetric immunoassay

BACKGROUND: Impaired levels or function of C1 inhibitor (C1‐INH) results in angioedema due to increased bradykinin. It is important to distinguish between angioedema related to C1‐INH deficiency and that caused by other mechanisms, as treatment options are different. In hereditary (HAE) and acquired...

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Autores principales: Tange, Clare E., Kaur, Amrit, Verma, Nisha, Hickey, Alaco, Grigoriadou, Sofia, Scott, Chris, Kiani, Sorena, Steven, Rachael, Ponsford, Mark, El‐Shanawany, Tariq, Jolles, Stephen, Harding, Stephen, Parker, Antony R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6430339/
https://www.ncbi.nlm.nih.gov/pubmed/30058083
http://dx.doi.org/10.1002/jcla.22627
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author Tange, Clare E.
Kaur, Amrit
Verma, Nisha
Hickey, Alaco
Grigoriadou, Sofia
Scott, Chris
Kiani, Sorena
Steven, Rachael
Ponsford, Mark
El‐Shanawany, Tariq
Jolles, Stephen
Harding, Stephen
Parker, Antony R.
author_facet Tange, Clare E.
Kaur, Amrit
Verma, Nisha
Hickey, Alaco
Grigoriadou, Sofia
Scott, Chris
Kiani, Sorena
Steven, Rachael
Ponsford, Mark
El‐Shanawany, Tariq
Jolles, Stephen
Harding, Stephen
Parker, Antony R.
author_sort Tange, Clare E.
collection PubMed
description BACKGROUND: Impaired levels or function of C1 inhibitor (C1‐INH) results in angioedema due to increased bradykinin. It is important to distinguish between angioedema related to C1‐INH deficiency and that caused by other mechanisms, as treatment options are different. In hereditary (HAE) and acquired (AAE) angioedema, C1‐INH concentration is measured to aid patient diagnosis. Here, we describe an automated turbidimetric assay to measure C1‐INH concentration on the Optilite(®) analyzer. METHODS: Linearity, precision, and interference were established over a range of C1‐INH concentrations. The 95th percentile reference interval was generated from 120 healthy adult donors. To compare the Optilite C1‐INH assay with a predicate assay used in a clinical laboratory, samples sent for C1‐INH investigation were used. The predicate results were provided to allow comparison. RESULTS: The Optilite C1‐INH assay was linear across the measuring range at the standard sample dilution. Intra and interassay variability was <6%. The 95th percentile adult reference interval for the assay was 0.21‐0.38 g/L. There was a strong correlation between the Optilite concentrations and those generated with the predicate assay (R (2 )= 0.94, P < 0.0001, slope y = 0.83x). All patients with Type I HAE (n = 24) and AAE (n = 3) tested had concentrations below the measuring range in both assays, while all patients with unspecified angioedema (UAE), not diagnosed with HAE or AAE had values within the reference range. CONCLUSION: The Optilite assay allows the automated and precise quantification of C1‐INH concentrations in patient samples. It could therefore be used as a tool to aid the investigation of patients with angioedema.
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spelling pubmed-64303392019-06-27 Quantification of human C1 esterase inhibitor protein using an automated turbidimetric immunoassay Tange, Clare E. Kaur, Amrit Verma, Nisha Hickey, Alaco Grigoriadou, Sofia Scott, Chris Kiani, Sorena Steven, Rachael Ponsford, Mark El‐Shanawany, Tariq Jolles, Stephen Harding, Stephen Parker, Antony R. J Clin Lab Anal Research Articles BACKGROUND: Impaired levels or function of C1 inhibitor (C1‐INH) results in angioedema due to increased bradykinin. It is important to distinguish between angioedema related to C1‐INH deficiency and that caused by other mechanisms, as treatment options are different. In hereditary (HAE) and acquired (AAE) angioedema, C1‐INH concentration is measured to aid patient diagnosis. Here, we describe an automated turbidimetric assay to measure C1‐INH concentration on the Optilite(®) analyzer. METHODS: Linearity, precision, and interference were established over a range of C1‐INH concentrations. The 95th percentile reference interval was generated from 120 healthy adult donors. To compare the Optilite C1‐INH assay with a predicate assay used in a clinical laboratory, samples sent for C1‐INH investigation were used. The predicate results were provided to allow comparison. RESULTS: The Optilite C1‐INH assay was linear across the measuring range at the standard sample dilution. Intra and interassay variability was <6%. The 95th percentile adult reference interval for the assay was 0.21‐0.38 g/L. There was a strong correlation between the Optilite concentrations and those generated with the predicate assay (R (2 )= 0.94, P < 0.0001, slope y = 0.83x). All patients with Type I HAE (n = 24) and AAE (n = 3) tested had concentrations below the measuring range in both assays, while all patients with unspecified angioedema (UAE), not diagnosed with HAE or AAE had values within the reference range. CONCLUSION: The Optilite assay allows the automated and precise quantification of C1‐INH concentrations in patient samples. It could therefore be used as a tool to aid the investigation of patients with angioedema. John Wiley and Sons Inc. 2018-07-29 /pmc/articles/PMC6430339/ /pubmed/30058083 http://dx.doi.org/10.1002/jcla.22627 Text en © 2018 The Authors Journal of Clinical Laboratory Analysis Published by Wiley Periodicals, Inc. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research Articles
Tange, Clare E.
Kaur, Amrit
Verma, Nisha
Hickey, Alaco
Grigoriadou, Sofia
Scott, Chris
Kiani, Sorena
Steven, Rachael
Ponsford, Mark
El‐Shanawany, Tariq
Jolles, Stephen
Harding, Stephen
Parker, Antony R.
Quantification of human C1 esterase inhibitor protein using an automated turbidimetric immunoassay
title Quantification of human C1 esterase inhibitor protein using an automated turbidimetric immunoassay
title_full Quantification of human C1 esterase inhibitor protein using an automated turbidimetric immunoassay
title_fullStr Quantification of human C1 esterase inhibitor protein using an automated turbidimetric immunoassay
title_full_unstemmed Quantification of human C1 esterase inhibitor protein using an automated turbidimetric immunoassay
title_short Quantification of human C1 esterase inhibitor protein using an automated turbidimetric immunoassay
title_sort quantification of human c1 esterase inhibitor protein using an automated turbidimetric immunoassay
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6430339/
https://www.ncbi.nlm.nih.gov/pubmed/30058083
http://dx.doi.org/10.1002/jcla.22627
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