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Comparison of Two Luminex Single-antigen Bead Flow Cytometry Assays for Detection of Donor-specific Antibodies After Renal Transplantation

Bertrand, Dominique, MD1; Farce, Fabienne, PharmD2; Laurent, Charlotte, MD1; Hamelin, Frédérique, AS2; François, Arnaud, MD3; Guerrot, Dominique, MD, PhD1; Etienne, Isabelle, MD1; Hau, Françoise, MD2

doi: 10.1097/TP.0000000000002351
Original Clinical Science—General
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Background. Defining the clinical relevance of donor-specific HLA antibodies (DSA) detection by Luminex single-antigen (LSA) flow beads assay is critical in monitoring posttransplant outcome.

Methods. Sera of kidney transplanted patients were tested by LSA1 and LSA2 with One Lambda Labscreen (test 1) and Immucor Lifecodes (test 2), at the time of a graft biopsy. The first group (G1, n = 50) had a biopsy highly suggestive of humoral rejection, and the second (G2, n = 50) had no criteria of rejection. Positivity criteria for DSA was mean fluorescence intensity greater than 500 for test 1, whereas specificity assignation respected the provider’s recommendations for test 2.

Results. In G1, we identified at least 1 DSA in 44 patients with test 1, and in 39 patients with test 2. In G2, test 1 identified at least 1 DSA in 16 (32%) patients and test 2 in 7 (14%) patients. Sensitivity and specificity for antibody-mediated rejection diagnosis was 88% and 68%, respectively, with One Lambda, and 78% and 86%, respectively, with Immucor. Correlation and agreement were found in class I and II between intensity parameters of the 2 manufacturers. The use of the sum of the intensity of DSA improved the sensitivity and specificity of the 2 tests.

Conclusions. We report the first comparative study of the 2 Luminex assays available for detecting DSA in the postkidney transplant setting. Although there is a good correlation and reliability between the 2 assays, significant differences exist. Positivity criteria for DSA determination differ and interpretation should take these specificities into account.

1Department of Nephrology and Transplantation, Rouen University Hospital, Rouen, France.

2Laboratory of Histocompatibility, EFS Normandie, Rouen, France.

3Department of Anatomy and Pathology, Rouen University Hospital, Rouen, France.

Received 7 February 2018. Revision received 18 June 2018.

Accepted 19 June 2018.

The authors declare no funding or conflicts of interest.

D.B. performed research, collected data, analyzed data, and wrote the article. F.F., F.Ham., F.Hau. collected the data, performed research. D.G. contributed to the revision and approval of the article. All the others authors collected data and contributed to the approval of the article.

Correspondence: Dominique Bertrand, MD, Rouen University Hospital 1 rue de Germont 76000 Rouen, France. (dominique.bertrand@chu-rouen.fr).

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