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Inter-Laboratory Comparison of Multi-AllergenSpecific Immunoglobulin E Screening Assay Using Polycheck Allergy Diagnostic
J Lab Med Qual Assur 2019;41:39-46
Published online March 31, 2019
© 2019 Korean Association of External Quality Assessment Service.

Young Ae Lim

Department of Laboratory Medicine, Ajou University School of Medicine, Suwon, Korea
Correspondence to: Young Ae Lim, Department of Laboratory Medicine, Ajou University School of Medicine, 164 World cup-ro, Yeongtong-gu, Suwon 16499, Korea Tel: +82-31-219-5786 Fax: +82-31-219-5778 E-mail: limyoung@ajou.ac.kr
Received November 21, 2018; Revised January 31, 2019; Accepted February 8, 2019.
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: Currently there is no external proficiency testing program for allergen-specific immunoglobulin E assays (sIgE) in Korea. The aim of this study was to evaluate the accuracy of sIgE performed in different laboratories in Korea using Polycheck Allergy Diagnostic (Biocheck GmbH, Germany) or simply 쁏olycheck and to further perform an inter-laboratory comparison of sIgE.
Methods: Three inter-laboratory trials were undertaken from June 2016 to December 2017 at nine institutions. Serum samples obtained from three patients who had a history of positive Polycheck results were used in each trial. A total of 59 allergens were evaluated from the standard panel, inhalation panel, and food panel. The acceptable rates (%) of classes 06 of the results were calculated using three different criteria, including the consensus of 80% participants of the College of American Pathologists (CAP), the most frequent value (MFV), and the Overall Misclassification Index Score (OMIS).
Results: The proportion of laboratories that showed acceptable results for CAP criteria, MFV, and OMIS were around 93.0%97.7%, 66.3%76.0%, and 0.11.3, respectively, in each trial. Under-performing institutes showed consistently higher (49/68, 72.1%) or lower (19/68, 27.9%) than acceptable results for all criteria.
Conclusions: This is the first study evaluating the inter-laboratory variation of sIgE in Korea using various criteria. It was found that the acceptable rate could be altered based on changes in these criteria. These findings might be useful for the inter-laboratory comparison of sIgE in Korea in the future as well.
Keywords : Laboratory proficiency testing, Allergen-specific immunoglobulin E, Quality control