Kluin-Nelemans J C, van Wering E R, van'T Veer M B, van der Schoot C E, Adriaansen H J, van der Burgh F J, Gratama J W
Department of Haematology, Leiden University Hospital, The Netherlands.
Br J Haematol. 1996 Dec;95(4):692-9. doi: 10.1046/j.1365-2141.1996.d01-1962.x.
During the last decade, biannual quality controls were performed in the Netherlands focusing on the immunophenotyping of leukaemic haematological malignancies. All results on 48 specimens obtained by 18-34 laboratories were analysed. The interlaboratory variability and percentages of discordant results from 30 markers were measured by assessing false positive or negative (cut-off 10%) results in comparison with median results of the group. The quality of the immunophenotypic diagnoses obtained from the interpretation of these markers in relation to clinical data was evaluated by scoring them as 'correct', 'minor fault', 'major fault', 'not based upon the markers used', and 'no diagnosis', CD3, CD8, CD19, CD61 and Sm lambda had the lowest percentage discordancy (sum of total negative and positive discordant values 5-7.5% of assays): CD13, CD15, cyCD22, CD33 and TdT scored worst with 14-20% cumulative discordancy. The analysis of each diagnosis yielded 78% acceptable immunophenotypic conclusions (correct 54% and minor fault 24%). It appeared that the major faults in immunophenotyping were caused by suboptimal antibody selection and erroneous interpretation of the results obtained, rather than by technical errors. Large differences per diagnostic category were observed, with the best scores for mature B-cell leukaemias, AMLs and common-ALL, and the poorest scores for T-cell malignancies which were correctly diagnosed in only 24-60% of specimens. Mature T-NHL and T-PLL were mistakenly diagnosed as T-ALL by 40% of the centres. Misinterpretation of TdT immunofluorescence or omitting this marker contributed significantly to these wrong diagnoses. A median of 4% of immunophenotypic diagnoses were not based on a correct panel of antibodies, but upon the morphology of the accompanying blood smear, and was often flawed by overinterpretation. In conclusion, both the technical performance of immunophenotyping of haematological malignancies in The Netherlands and the procedure by which a final diagnosis is obtained needs improvement, especially for T-cell malignancies.
在过去十年间，荷兰开展了针对白血病血液系统恶性肿瘤免疫表型分析的两年一次的质量控制。对18至34个实验室获得的48份标本的所有结果进行了分析。通过评估与该组中位数结果相比的假阳性或阴性（临界值10%）结果，测量了30个标志物的实验室间变异性和不一致结果的百分比。通过将这些标志物的解释与临床数据相关的免疫表型诊断质量评为“正确”“小错误”“大错误”“未基于所用标志物”和“无诊断”来进行评估。CD3、CD8、CD19、CD61和Smλ的不一致百分比最低（总阴性和阳性不一致值之和占检测的5 - 7.5%）：CD13、CD15、cyCD22、CD33和TdT得分最差，累积不一致率为14 - 20%。对每个诊断的分析得出78%可接受的免疫表型结论（正确的占54%，小错误占24%）。似乎免疫表型分析中的主要错误是由抗体选择欠佳和对所得结果的错误解释导致的，而非技术错误。观察到每个诊断类别存在很大差异，成熟B细胞白血病、急性髓系白血病和普通型急性淋巴细胞白血病得分最佳，而T细胞恶性肿瘤得分最差，仅在24 - 60%的标本中被正确诊断。40%的中心将成熟T细胞非霍奇金淋巴瘤和T细胞幼淋巴细胞白血病误诊为T细胞急性淋巴细胞白血病。TdT免疫荧光的错误解读或遗漏该标志物对这些错误诊断有显著影响。中位数为4%的免疫表型诊断并非基于正确的抗体组合，而是基于伴随血涂片的形态，且常常因过度解读而存在缺陷。总之，荷兰血液系统恶性肿瘤免疫表型分析的技术性能以及获得最终诊断的程序都需要改进，尤其是对于T细胞恶性肿瘤。
