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