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

Oh EJ, Park H, Park KU, Kang ES, Kim HS, Song EY - Ann Lab Med (2015)

Bottom Line: 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 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).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.

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.

No MeSH data available.


Box plots (minimum, first quartile, median value, third quartile, and maximum value) of CV (%) for median fluorescence intensity (MFI) values separated by distinct MFI ranges and grouped by the mean MFI values from the five participating laboratories (<1,000; 1,000-2,999; 3,000-4,999; 5,000-9,999; and ≥10,000). Asterisk means outlier greater than 3 times the interquartile range. Open circle means outlier greater than 1.5 times the interquartile range. (A) contains data for HLA class I antibody detection; (B) contains data for HLA class II antibody detection.
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Figure 3: Box plots (minimum, first quartile, median value, third quartile, and maximum value) of CV (%) for median fluorescence intensity (MFI) values separated by distinct MFI ranges and grouped by the mean MFI values from the five participating laboratories (<1,000; 1,000-2,999; 3,000-4,999; 5,000-9,999; and ≥10,000). Asterisk means outlier greater than 3 times the interquartile range. Open circle means outlier greater than 1.5 times the interquartile range. (A) contains data for HLA class I antibody detection; (B) contains data for HLA class II antibody detection.

Mentions: Analysis of the CV (%) values from the five laboratories according to the mean MFI values of each bead for HLA Class I and Class II antibodies are shown in Fig. 3. For Class I, the median CV (%) for the MFI values among five laboratories in the lower MFI range (<1,000) was significantly higher than those for the other MFI ranges (all P<0.001). For Class II, the median CV (%) for the MFI values among five laboratories in the lower MFI range (<1,000) was significantly higher than CV (%) for the MFI range 3,000-4,999 (P=0.003) and other MFI ranges (all P<0.001).


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

Oh EJ, Park H, Park KU, Kang ES, Kim HS, Song EY - Ann Lab Med (2015)

Box plots (minimum, first quartile, median value, third quartile, and maximum value) of CV (%) for median fluorescence intensity (MFI) values separated by distinct MFI ranges and grouped by the mean MFI values from the five participating laboratories (<1,000; 1,000-2,999; 3,000-4,999; 5,000-9,999; and ≥10,000). Asterisk means outlier greater than 3 times the interquartile range. Open circle means outlier greater than 1.5 times the interquartile range. (A) contains data for HLA class I antibody detection; (B) contains data for HLA class II antibody detection.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4390700&req=5

Figure 3: Box plots (minimum, first quartile, median value, third quartile, and maximum value) of CV (%) for median fluorescence intensity (MFI) values separated by distinct MFI ranges and grouped by the mean MFI values from the five participating laboratories (<1,000; 1,000-2,999; 3,000-4,999; 5,000-9,999; and ≥10,000). Asterisk means outlier greater than 3 times the interquartile range. Open circle means outlier greater than 1.5 times the interquartile range. (A) contains data for HLA class I antibody detection; (B) contains data for HLA class II antibody detection.
Mentions: Analysis of the CV (%) values from the five laboratories according to the mean MFI values of each bead for HLA Class I and Class II antibodies are shown in Fig. 3. For Class I, the median CV (%) for the MFI values among five laboratories in the lower MFI range (<1,000) was significantly higher than those for the other MFI ranges (all P<0.001). For Class II, the median CV (%) for the MFI values among five laboratories in the lower MFI range (<1,000) was significantly higher than CV (%) for the MFI range 3,000-4,999 (P=0.003) and other MFI ranges (all P<0.001).

Bottom Line: 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 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).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.

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.

No MeSH data available.