BAG Diagnostics GmbH, Amtsgerichtstr 1-5, 35423 Lich, Germany.
Innobiochips, 70, rue du Docteur Yersin, 59 120 Loos, France.
J Immunol Methods. 2021 Apr;491:112971. doi: 10.1016/j.jim.2021.112971. Epub 2021 Feb 4.
The purpose of this study was to analyze performance of a new single antigen chip array system (HISTO SPOT® HLA AB) developed for HLA antibody detection and compare with results obtained using single antigen Luminex-based systems and serum samples from the Eurotransplant external proficiency testing scheme. Results were analysed from 11 independent Eurotransplant laboratories using HISTO SPOT® HLA AB utilising the Eurotransplant external proficiency testing (EPT) sera and these were compared to published results from 67 labs using the Luminex-based technologies. In addition, QC results from different batches of the test were analysed. Generally, concordance of results with the results from the Luminex technique was good. With the Luminex tests more consensus results and more questionable results were found than with the HISTO SPOT® HLA AB test. Within the HISTO SPOT® HLA AB testing group we found a discrepancy rate from the consensus of 2.9% for the EPT sera which is far below the 25% allowed to pass the quality test and only slightly higher than for the Luminex single antigen tests with 1.2%. The average global coefficient of variation (CV) of the mean signal (raw data) for the HISTO SPOT® HLA AB test was 13% which is lower than the values reported for Luminex tests in the literature. The average global CV for the signal/background ratio was higher with 28%. In the present study, the mean signal is the best parameter to compare results between labs and the new HISTO SPOT® HLA AB test is at least as good in terms of signal reproducibility as the Luminex tests. In conclusion, the HISTO SPOT® HLA AB test is a good alternative to be used in addition or instead of the Luminex tests in clinical labs.
本研究的目的是分析一种新的单抗原芯片阵列系统（HISTO SPOT® HLA AB）的性能，该系统用于 HLA 抗体检测，并将其结果与使用单抗原 Luminex 系统和 Eurotransplant 外部能力验证计划的血清样本进行比较。使用 HISTO SPOT® HLA AB 分析了来自 11 个独立的 Eurotransplant 实验室的结果，这些实验室利用 Eurotransplant 外部能力验证（EPT）血清，并将这些结果与使用基于 Luminex 的技术的 67 个实验室的已发表结果进行了比较。此外，还分析了不同批次测试的 QC 结果。通常，与 Luminex 技术结果的一致性很好。与 HISTO SPOT® HLA AB 测试相比，使用 Luminex 测试发现了更多的共识结果和更多的可疑结果。在 HISTO SPOT® HLA AB 测试组内，我们发现 EPT 血清的共识差异率为 2.9%，远低于通过质量测试的 25%，仅略高于 Luminex 单抗原测试的 1.2%。HISTO SPOT® HLA AB 测试的平均信号（原始数据）的全球平均变异系数（CV）为 13%，低于文献中报道的 Luminex 测试值。信号/背景比的全球平均 CV 更高，为 28%。在本研究中，平均信号是比较实验室间结果的最佳参数，新的 HISTO SPOT® HLA AB 测试在信号重现性方面至少与 Luminex 测试一样好。总之，HISTO SPOT® HLA AB 测试是临床实验室中替代或补充 Luminex 测试的良好选择。
