Performance Comparison of ImmunoCAP and HYTEC 288 in the Quantitative Tests of Allergen-specific IgE

Seung Hee Lee; Sun Min Lee; Hyung Hoi Kim; Chulhun L. Chang; Eun Yup Lee

doi:10.3343/lmo.2014.4.1.43

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Lee, Lee, Kim, Chang, and Lee: Performance Comparison of ImmunoCAP and HYTEC 288 in the Quantitative Tests of Allergen-specific IgE

Original Article

Diagnostic Immunology

Laboratory Medicine Online 2014; 4(1): 43-50.

Published online: 1 January 2014

DOI: https://doi.org/10.3343/lmo.2014.4.1.43

Performance Comparison of ImmunoCAP and HYTEC 288 in the Quantitative Tests of Allergen-specific IgE

Seung Hee Lee, M.D.^1,², Sun Min Lee, M.D.^1,³, Hyung Hoi Kim, M.D.^1,², Chulhun L. Chang, M.D.^1,³, Eun Yup Lee, M.D.^1,²

¹Department of Laboratory Medicine, Pusan National University School of Medicine, Busan, Korea.

²Department of Laboratory Medicine, Pusan National University Hospital, Busan, Korea.

³Department of Laboratory Medicine and Molecular Genetics, Pusan National University Yangsan Hospital, Yangsan, Korea.

Corresponding author: Sun Min Lee. Department of Laboratory Medicine, Pusan National University School of Medicine and Pusan National University Yangsan Hospital, 20 Geumo-ro, Yangsan 626-770, Korea. Tel: +82-55-360-1875, Fax: +82-55-360-1880, yaong97@hanmail.net

Received 12 July 2013 Revised 7 October 2013 Accepted 7 October 2013

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

In vitro measurement of allergen-specific IgE has become an important part of allergy diagnoses. HYTEC 288 system (Hycor Biomedical Inc., USA), which was recently introduced in Korea, is a fully automated immunoassay for quantitative measurements of allergen-specific IgE. In this study, we compared the clinical utility of this in vitro allergy test with that of ImmunoCAP assay (ImmunoDiagnostics, Sweden).

Methods

To evaluate the reproducibility of HYTEC 288 system, 50 serum samples were tested in duplicate each for Dermatophagoides pteronyssinus (d1) and D. farinae (d2) specific IgE. To assess the agreement between ImmunoCAP and HYTEC 288 assays, 56 serum samples were tested for the other 21 allergen-specific IgE.

Results

No significant differences within the range of quantitative analysis were observed between HYTEC 288 and ImmunoCAP assays for d1 and d2 (P=0.65 and 0.55, respectively). The agreements of HYTEC allergen-specific IgE assay with ImmunoCAP within ±1 class grade were 80% and 100% for d1 and d2, respectively. The correlation coefficients between HYTEC 288 and ImmunoCAP results within the range of quantitative analysis were overally 0.90, regardless of allergen, for d1 and d2 specific IgE, 0.91 and 0.98, respectively. Running times for the HYTEC 288 and Phardia 100 were 5.5 and 4.6 min per test, respectively.

Conclusions

Hycor HYTEC 288 showed a favorable agreement with ImmunoCAP and can be used for fully automated quantitative measurements of allergen-specific IgE in the clinical laboratory.

Keywords: Immunoglobulin E, Immunoassay, Allergy, Automation, Laboratory

Figures and Tables

Fig. 1

Comparison of serum specific IgE levels measured by ImmunoCAP and HYTEC assays. (A, B) Scatter plot with Deming fit and residual plot of 84 allergen-specific IgE results within the range of quantitative analysis. (C, D) Scatter plot with Deming fit and difference plot of d1-specific IgE. (E, F) Scatter plot with Deming fit and difference plot of d2-specific IgE.

Table 1

Tested allergens and agreement between ImmunoCAP and HYTEC assays

Table 2

Reproducibility of Hycor HYTEC 288 test results in Dermatophagoides pteronyssinus and D. farinae

Table 3

Analysis of discrepant results between HYTEC 288 and ImmunoCAP compared with clinical diagnosis (N=26)

Bolded; clinically more significant results.

Abbreviation: NT, not tested.

Table 4

Running time of Phadia100 and HYTEC 288 systems

Notes

This article is available from http://www.labmedonline.org

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