Article

Original Article

Ann Lab Med 2015; 35(3): 321-328

Published online May 1, 2015 https://doi.org/10.3343/alm.2015.35.3.321

Copyright © Korean Society for Laboratory Medicine.

Interlaboratory Comparison of the Results of Lifecodes LSA Class I and Class II Single Antigen Kits for Human Leukocyte Antigen Antibody Detection

Eun-Jee Oh, M.D.1, Hyewon Park, M.D.2, Kyoung Un Park, M.D.2,3, Eun-Suk Kang, M.D.4, Hyon-Suk Kim, M.D.5, and Eun Young Song, M.D.2,6

Department of Laboratory Medicine1, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul; Department of Laboratory Medicine2, Seoul National University College of Medicine, Seoul; Department of Laboratory Medicine3, Seoul National University Bundang Hospital, Seongnam; Department of Laboratory Medicine and Genetics4, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Laboratory Medicine5, Severance Hospital, Yonsei University College of Medicine, Seoul; Department of Molecular Medicine and Biopharmaceutical Sciences6, Graduate School of Convergence Science and Technology and College of Medicine, Medical Research Center, Seoul National University, Seoul, Korea

Correspondence to: Eun Young Song
Department of Laboratory Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul 110-744, Korea
Tel: +82-2-2072-0197
Fax: +82-2-3672-3337
E-mail: eysong1@snu.ac.kr

Received: October 27, 2014; Revised: November 29, 2014; Accepted: February 7, 2015

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: Although single antigen bead assays (SAB) are approved qualitative tests, the median fluorescence intensity (MFI) values obtained from SAB are frequently used in combination with quantitative significances for diagnostic purposes. To gauge the reproducibility of SAB results, we assessed the interlaboratory variability of MFI values using identical kits with reagents from the same lot and the manufacturer's protocol.
Methods: Six serum samples containing HLA-specific antibodies were analyzed at five laboratories by using Lifecodes LSA Class I and Class II SAB kits (Immucor, USA) from the same lot, according to the manufacturer's protocol. We analyzed the concordance of qualitative results according to distinct MFI cutoffs (1,000, 3,000, 5,000, and 10,000), and the correlation of quantitative MFI values obtained by the participating laboratories. The CV for MFI values were analyzed and grouped by mean MFI values from the five laboratories (<1,000; 1,000-2,999; 3,000-4,999; 5,000-9,999; and ≥10,000).
Results: The categorical results obtained from the five laboratories exhibited concordance rates of 96.0% and 97.2% for detection of HLA class I and class II antibodies, respectively. The Pearson correlation coefficients for MFI values of class I and class II antibodies were between 0.947-0.991 and 0.992-0.997, respectively. The median CVs for the MFI values among five laboratories in the lower MFI range (<1,000) were significantly higher than those for the other MFI ranges (all P<0.01).
Conclusions: Analysis of SAB performed in five laboratories using identical protocols and reagents from the same lot resulted in high levels of concordance and strong correlation of results.

Keywords: Antibody specificity, Correlation, HLA antigens, Histocompatibility testing, Laboratories, Concordance