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

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 -