BCR::ABL1 p210转录水平定量检测多中心比对  

Comparison of quantitative detection of BCR::ABL1 p210 transcript levels:a multicenter study

作　　者：赵楚婷 倪灿荣[2] 蔺亚妮 马小丽 吴祁生 王芳 韩晓雪 刘丰 徐阳 刘红星 陈杰[9] 汝昆 朱明华[2] Zhao Chuting;Ni Canrong;Lin Yani;Ma Xiaoli;Wu Qisheng;Wang Fang;Han Xiaoxue;Liu Feng;Xu Yang;Liu Hongxing;Chen Jie;Ru Kun;Zhu Minghua(SINO-US Diagnostics Lab,Tianjin Enterprise Key Laboratory of Al-aided Hematopathology Diagnosis,Tianjin 300385,China;Department of Pathology,Shanghai Changhai Hospital,Shanghai 200433,China;Department of Laboratory Medicine,Hebei Yanda Lu Daopei Hospital,Langfang 065200,China;Pathology and Laboratory Medicine Division,Beijing Ludaopei Hospital,Beijing 100176,China;Kindstar Diagnostics,Wuhan 430075,China;Tianjin Kingmed Center for Clinical Laboratory,Tianjin 300392,China;Molecular Diagnostics Laboratory,Beijing GoBroad Boren Hospital,Beijing 100070,China;Hangzhou Dian Medical Laboratory Center Co Ltd,Hangzhou 310030,China;Department of Pathology,Peking Union Medical College Hospital,Chinese Academy of medical Sciences,Peking Union Medical College,Beijing 100730,China;Department of Pathology and Lab Medicine,Shandong Cancer Hospital,Jinan 250117,China)

机构地区：[1]天津见康华美医学诊断中心,天津300385 [2]上海长海医院病理科,上海200433 [3]河北燕达陆道培医院检验医学科,廊坊065200 [4]北京陆道培医院病理和检验医学科,北京100176 [5]武汉康圣达医学检验所有限公司,武汉430075 [6]天津金域医学检验实验室有限公司,天津300392 [7]北京高博博仁医院分子诊断实验室,北京100070 [8]杭州迪安医学检验中心,杭州310030 [9]中国医学科学院,北京协和医学院,北京协和医院病理科,北京100730 [10]山东省肿瘤医院病理检验特检中心,济南250117

出　　处：《中华病理学杂志》2024年第7期672-677,共6页Chinese Journal of Pathology

摘　　要：目的评估7家独立医学实验室BCR::ABL1 p210转录水平定量检测能力及实验室之间结果的可比性。方法比对分两个阶段完成,由参考实验室制备比对样本,每个阶段比对样本的BCR::ABL1 p210定量值均覆盖0.001%~0.01%、0.01%~0.1%、0.1%~1%、1%~10%及>10%。各比对实验室分别采用即时荧光定量PCR法(real-time quantitative PCR,RT-PCR)和数字PCR法(digital PCR,dPCR)进行比对样本的检测,计算并确认各比对实验室转换因子(conversion factor,CF)。结果(1)RT-PCR比对中,1家实验室第一阶段14例样本未检出,其余6家实验室比对结果合格,偏倚<±1.2倍(-0.133~0.338),95%一致性界限<±5倍(上限0.147~0.785,下限-0.770~-0.109),计算并确认CF值;(2)dPCR比对中,1家实验室第二阶段未回报结果,其余6家实验室比对结果合格,偏倚<±1.2倍(-0.026~0.267),95%一致性界限<±5倍(上限0.084~0.991,下限-0.669~-0.135),计算并确认CF值;(3)BCR::ABL1 p210定量值为0.01%~0.1%、0.1%~1%、1%~10%及>10%时,RT-PCR和dPCR均能全部检出;BCR::ABL1 p210定量值为0.001%~0.01%时,dPCR检出率高于RT-PCR法(85.56%比68.00%)。结论各比对实验室结果呈较好一致性,各实验室间BCR::ABL1 p210定量检测通过CF值换算具备可比性;BCR::ABL1 p210深度分子反应定量检测中,dPCR法阳性检出率更高,更有优势;为保证检测结果的准确性和稳定性,各实验室应加强日常质控工作。Objective To assess the capability of seven reference medical laboratories to detect BCR::ABL1 p210 transcription levels and to compare the results among those laboratories.Methods The interlaboratory comparison was carried out in two stages.The samples were prepared by the reference laboratory.The quantitative values of BCR::ABL1 p210 of the comparison samples covered 0.001%-0.01%,0.01%-0.1%,0.1%-1%,1%-10%and>10%in each stage.Real-time quantitative PCR(RT-PCR)and dPCR(digital PCR)were used to examine the samples.The conversion factor(CF)was calculated and validated for each laboratory.Results In the RT-PCR comparison,one laboratory was failed to detect BCR::ABL1 p210 in fourteen samples at the first stage.The results of the other six laboratories were qualified with the bias<±1.2 folds(-0.133-0.338)and 95%limits of agreement within±5 folds(upper limit 0.147-0.785,lower limit-0.770--0.109),and the corresponding CF values were calculated and validated.In the dPCR comparison,one laboratory did not report results at the second stage.The results of the other six laboratories were qualified with the bias<±1.2 folds(-0.026-0.267)and 95%limits of agreement within±5 folds(upper limit 0.084-0.991,lower limit-0.669--0.135),and the corresponding CF values were calculated and validated.The samples with BCR::ABL1 p210 quantitative values of 0.01%-0.1%,0.1%-1%,1%-10%and>10%could be detected by both RT-PCR and qPCR.When the quantitative value of BCR::ABL1 p210 was 0.001%-0.01%,the detection rate of dPCR was higher than that of RT-PCR(85.56%vs.68.00%).Conclusions A good consistency is present among various laboratories.The quantitative value of BCR::ABL1 p210 is comparable among laboratories as shown by the CF value conversion.For quantitative detection of BCR::ABL1 p210 deep molecular reaction,dPCR has a higher positive detection rate and more advantages than RT-PCR.To ensure the accuracy and reproducibility of the BCR::ABL1 p210 test,it is imperative for every laboratory to enhance their daily quality control practices.

关 键 词：白血病 髓系 慢性 BCR-ABL阳性 融合蛋白质类 bcr-abl 实时聚合酶链反应 

分 类 号：R733.7[医药卫生—肿瘤]