Performance evaluation of a specific IgE assay developed for the ADVIA centaur immunoassay system

Anita Birgit Petersen; Pernille Gudmann; Pernille Milvang-Grønager; Rikke Mørkeberg; Søren Bøgestrand; Allan Linneberg; Niels Johansen

doi:10.1016/j.clinbiochem.2004.06.010

Performance evaluation of a specific IgE assay developed for the ADVIA centaur immunoassay system

Anita Birgit Petersen, Pernille Gudmann, Pernille Milvang-Grønager, Rikke Mørkeberg, Søren Bøgestrand, Allan Linneberg, Niels Johansen

125 Citationer (Scopus)

Abstract

OBJECTIVE: To develop and evaluate a liquid phase immunoassay for accurate determination of allergen-specific IgE (sIgE) as a useful tool in the diagnosis of allergy patients.

DESIGN AND METHODS: A fully automated, quantitative sIgE assay was developed for the ADVIA Centaur technology platform using a unique calibration method based on a recombinant reference allergen. Compared to most other IgE-assays, the assay employs a reverse sandwich architecture using monoclonal mouse anti-human IgE antibody covalently bound to paramagnetic particles in the solid phase and capturing the sample IgE. Bound sIgE reacts with liquid biotin-labeled allergen, which is detected as chemiluminescence using acridiniumester-labeled streptavidin.

RESULTS: The ADVIA Centaur sIgE assay (Centaur assay) has exclusive reactivity to human IgE and performs with excellent linearity in the assay range 0.35-100 kU/L and high precision (imprecision within-run <2.6%, between-run <4.9%, and total imprecision <7.1%). The analytical sensitivity is <0.10 kU/L. Using Pharmacia CAP system FEIA (CAP) as a comparative method, positive/negative concordance was 94% at 0.35 kU/L cut-off, and the Centaur assay has a sensitivity of 90% and a specificity of 98%. Validation of the assay in a general population sample (The Copenhagen allergy study) revealed that sIgE was highly associated with a clinical diagnosis of inhalation allergy.

CONCLUSIONS: The Centaur assay is an allergen-specific assay for measurement of IgE without interference from other types of immunoglobulins or nonspecific IgE. The assay performs with a linear reaction, high assay range, and good reproducibility. The assay correlates well with the CAP system and is in agreement with clinical diagnosis.

Originalsprog	Engelsk
Tidsskrift	Clinical Biochemistry
Vol/bind	37
Udgave nummer	10
Sider (fra-til)	882-92
Antal sider	11
ISSN	0009-9120
DOI	https://doi.org/10.1016/j.clinbiochem.2004.06.010
Status	Udgivet - okt. 2004
Udgivet eksternt	Ja

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10.1016/j.clinbiochem.2004.06.010

Citationsformater

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title = "Performance evaluation of a specific IgE assay developed for the ADVIA centaur immunoassay system",

abstract = "OBJECTIVE: To develop and evaluate a liquid phase immunoassay for accurate determination of allergen-specific IgE (sIgE) as a useful tool in the diagnosis of allergy patients.DESIGN AND METHODS: A fully automated, quantitative sIgE assay was developed for the ADVIA Centaur technology platform using a unique calibration method based on a recombinant reference allergen. Compared to most other IgE-assays, the assay employs a reverse sandwich architecture using monoclonal mouse anti-human IgE antibody covalently bound to paramagnetic particles in the solid phase and capturing the sample IgE. Bound sIgE reacts with liquid biotin-labeled allergen, which is detected as chemiluminescence using acridiniumester-labeled streptavidin.RESULTS: The ADVIA Centaur sIgE assay (Centaur assay) has exclusive reactivity to human IgE and performs with excellent linearity in the assay range 0.35-100 kU/L and high precision (imprecision within-run <2.6%, between-run <4.9%, and total imprecision <7.1%). The analytical sensitivity is <0.10 kU/L. Using Pharmacia CAP system FEIA (CAP) as a comparative method, positive/negative concordance was 94% at 0.35 kU/L cut-off, and the Centaur assay has a sensitivity of 90% and a specificity of 98%. Validation of the assay in a general population sample (The Copenhagen allergy study) revealed that sIgE was highly associated with a clinical diagnosis of inhalation allergy.CONCLUSIONS: The Centaur assay is an allergen-specific assay for measurement of IgE without interference from other types of immunoglobulins or nonspecific IgE. The assay performs with a linear reaction, high assay range, and good reproducibility. The assay correlates well with the CAP system and is in agreement with clinical diagnosis.",

keywords = "Allergens, Automation, Humans, Hypersensitivity, Immunoassay, Immunoglobulin E, Luminescent Measurements, Magnetics, Reproducibility of Results, Sensitivity and Specificity, Journal Article, Research Support, Non-U.S. Gov't, Validation Studies",

author = "Petersen, {Anita Birgit} and Pernille Gudmann and Pernille Milvang-Gr{\o}nager and Rikke M{\o}rkeberg and S{\o}ren B{\o}gestrand and Allan Linneberg and Niels Johansen",

year = "2004",

month = oct,

doi = "10.1016/j.clinbiochem.2004.06.010",

language = "English",

volume = "37",

pages = "882--92",

journal = "Clinical Biochemistry",

issn = "0009-9120",

publisher = "Elsevier",

number = "10",

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TY - JOUR

T1 - Performance evaluation of a specific IgE assay developed for the ADVIA centaur immunoassay system

AU - Petersen, Anita Birgit

AU - Gudmann, Pernille

AU - Milvang-Grønager, Pernille

AU - Mørkeberg, Rikke

AU - Bøgestrand, Søren

AU - Linneberg, Allan

AU - Johansen, Niels

PY - 2004/10

Y1 - 2004/10

N2 - OBJECTIVE: To develop and evaluate a liquid phase immunoassay for accurate determination of allergen-specific IgE (sIgE) as a useful tool in the diagnosis of allergy patients.DESIGN AND METHODS: A fully automated, quantitative sIgE assay was developed for the ADVIA Centaur technology platform using a unique calibration method based on a recombinant reference allergen. Compared to most other IgE-assays, the assay employs a reverse sandwich architecture using monoclonal mouse anti-human IgE antibody covalently bound to paramagnetic particles in the solid phase and capturing the sample IgE. Bound sIgE reacts with liquid biotin-labeled allergen, which is detected as chemiluminescence using acridiniumester-labeled streptavidin.RESULTS: The ADVIA Centaur sIgE assay (Centaur assay) has exclusive reactivity to human IgE and performs with excellent linearity in the assay range 0.35-100 kU/L and high precision (imprecision within-run <2.6%, between-run <4.9%, and total imprecision <7.1%). The analytical sensitivity is <0.10 kU/L. Using Pharmacia CAP system FEIA (CAP) as a comparative method, positive/negative concordance was 94% at 0.35 kU/L cut-off, and the Centaur assay has a sensitivity of 90% and a specificity of 98%. Validation of the assay in a general population sample (The Copenhagen allergy study) revealed that sIgE was highly associated with a clinical diagnosis of inhalation allergy.CONCLUSIONS: The Centaur assay is an allergen-specific assay for measurement of IgE without interference from other types of immunoglobulins or nonspecific IgE. The assay performs with a linear reaction, high assay range, and good reproducibility. The assay correlates well with the CAP system and is in agreement with clinical diagnosis.

AB - OBJECTIVE: To develop and evaluate a liquid phase immunoassay for accurate determination of allergen-specific IgE (sIgE) as a useful tool in the diagnosis of allergy patients.DESIGN AND METHODS: A fully automated, quantitative sIgE assay was developed for the ADVIA Centaur technology platform using a unique calibration method based on a recombinant reference allergen. Compared to most other IgE-assays, the assay employs a reverse sandwich architecture using monoclonal mouse anti-human IgE antibody covalently bound to paramagnetic particles in the solid phase and capturing the sample IgE. Bound sIgE reacts with liquid biotin-labeled allergen, which is detected as chemiluminescence using acridiniumester-labeled streptavidin.RESULTS: The ADVIA Centaur sIgE assay (Centaur assay) has exclusive reactivity to human IgE and performs with excellent linearity in the assay range 0.35-100 kU/L and high precision (imprecision within-run <2.6%, between-run <4.9%, and total imprecision <7.1%). The analytical sensitivity is <0.10 kU/L. Using Pharmacia CAP system FEIA (CAP) as a comparative method, positive/negative concordance was 94% at 0.35 kU/L cut-off, and the Centaur assay has a sensitivity of 90% and a specificity of 98%. Validation of the assay in a general population sample (The Copenhagen allergy study) revealed that sIgE was highly associated with a clinical diagnosis of inhalation allergy.CONCLUSIONS: The Centaur assay is an allergen-specific assay for measurement of IgE without interference from other types of immunoglobulins or nonspecific IgE. The assay performs with a linear reaction, high assay range, and good reproducibility. The assay correlates well with the CAP system and is in agreement with clinical diagnosis.

KW - Allergens

KW - Automation

KW - Humans

KW - Hypersensitivity

KW - Immunoassay

KW - Immunoglobulin E

KW - Luminescent Measurements

KW - Magnetics

KW - Reproducibility of Results

KW - Sensitivity and Specificity

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

KW - Validation Studies

U2 - 10.1016/j.clinbiochem.2004.06.010

DO - 10.1016/j.clinbiochem.2004.06.010

M3 - Journal article

C2 - 15369719

SN - 0009-9120

VL - 37

SP - 882

EP - 892

JO - Clinical Biochemistry

JF - Clinical Biochemistry

IS - 10

ER -

Performance evaluation of a specific IgE assay developed for the ADVIA centaur immunoassay system

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