Zhao C T, Ni C R, Lin Y N, Ma X L, Wu Q S, Wang F, Han X X, Liu F, Xu Y, Liu H X, Chen J, Ru K, Zhu M H
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.
Zhonghua Bing Li Xue Za Zhi. 2024 Jul 8;53(7):672-677. doi: 10.3760/cma.j.cn112151-20240110-00024.
To assess the capability of seven reference medical laboratories to detect BCR::ABL1 p210 transcription levels and to compare the results among those laboratories. 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. 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%). 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.
评估七家参考医学实验室检测BCR::ABL1 p210转录水平的能力，并比较这些实验室之间的结果。实验室间比对分两个阶段进行。样本由参考实验室制备。每个阶段比对样本的BCR::ABL1 p210定量值覆盖0.001%-0.01%、0.01%-0.1%、0.1%-1%、1%-10%和>10%。采用实时定量聚合酶链反应（RT-PCR）和数字PCR（dPCR）检测样本。计算并验证每个实验室的转换因子（CF）。在RT-PCR比对中，一个实验室在第一阶段未能检测出14个样本中的BCR::ABL1 p210。其他六个实验室的结果合格，偏差<±1.2倍（-0.133-0.338），95%一致性界限在±5倍以内（上限0.147-0.785，下限-0.770--0.109），并计算和验证了相应的CF值。在dPCR比对中，一个实验室在第二阶段未报告结果。其他六个实验室的结果合格，偏差<±1.2倍（-0.026-0.267），95%一致性界限在±5倍以内（上限0.084-0.991，下限-0.669--0.135），并计算和验证了相应的CF值。BCR::ABL1 p210定量值为0.01%-0.1%、0.1%-1%、1%-10%和>10%的样本，RT-PCR和qPCR均可检测到。当BCR::ABL1 p210定量值为0.001%-0.01%时，dPCR的检测率高于RT-PCR（85.56%对68.00%）。各实验室之间存在良好的一致性。通过CF值转换表明，各实验室间BCR::ABL1 p210的定量值具有可比性。对于BCR::ABL1 p210深度分子反应的定量检测，dPCR比RT-PCR具有更高的阳性检测率和更多优势。为确保BCR::ABL1 p210检测的准确性和可重复性，每个实验室必须加强日常质量控制措施。
