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


Journal

Journal of clinical laboratory analysis
ISSN: 1098-2825
Titre abrégé: J Clin Lab Anal
Pays: United States
ID NLM: 8801384

Informations de publication

Date de publication:
Jan 2019
Historique:
received: 29 05 2018
revised: 02 07 2018
accepted: 03 07 2018
pubmed: 31 7 2018
medline: 16 2 2019
entrez: 31 7 2018
Statut: ppublish

Résumé

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 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. 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 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.

Sections du résumé

BACKGROUND 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
METHODS 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 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
CONCLUSION CONCLUSIONS
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.

Identifiants

pubmed: 30058083
doi: 10.1002/jcla.22627
pmc: PMC6430339
doi:

Substances chimiques

Complement C1 Inhibitor Protein 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e22627

Informations de copyright

© 2018 The Authors Journal of Clinical Laboratory Analysis Published by Wiley Periodicals, Inc.

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Auteurs

Clare E Tange (CE)

The Binding Site Group Limited, Birmingham, UK.

Amrit Kaur (A)

The Binding Site Group Limited, Birmingham, UK.

Nisha Verma (N)

Barts Health NHS Trust, London, UK.

Alaco Hickey (A)

Barts Health NHS Trust, London, UK.

Sofia Grigoriadou (S)

Barts Health NHS Trust, London, UK.

Chris Scott (C)

Barts Health NHS Trust, London, UK.

Sorena Kiani (S)

Barts Health NHS Trust, London, UK.

Rachael Steven (R)

Immunodeficiency Centre for Wales, University Hospital of Wales, Cardiff, UK.

Mark Ponsford (M)

Immunodeficiency Centre for Wales, University Hospital of Wales, Cardiff, UK.

Tariq El-Shanawany (T)

Immunodeficiency Centre for Wales, University Hospital of Wales, Cardiff, UK.

Stephen Jolles (S)

Immunodeficiency Centre for Wales, University Hospital of Wales, Cardiff, UK.

Stephen Harding (S)

The Binding Site Group Limited, Birmingham, UK.

Antony R Parker (AR)

The Binding Site Group Limited, Birmingham, UK.

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