National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, PR China; National Center for Clinical Laboratories, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, PR China; Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, PR China.
National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, PR China; Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, PR China.
Clin Chim Acta. 2025 Jan 15;565:119991. doi: 10.1016/j.cca.2024.119991. Epub 2024 Oct 5.
Quantification of BCR::ABL1 monitors minimal residual disease, thus critical for patient stratification. While significant progress has been made in enhancing the accuracy of p210 BCR::ABL1 quantification, no equivalent standardization has been conducted for p190 BCR::ABL1. Therefore, we developed p190 BCR::ABL1 reference materials to calibrate the quantitative process through an innovative plasmid-based calibration strategy. Then, we further explored the use of p190 and p210 reference materials to standardize tests in 159 laboratories across China and assessed their detection capability utilizing quality assessment samples. Results suggested that after calibration, the coefficient of variation of detection results decreased from 50.8 %-57.4 % to 24.9 %-36.4 % for p190, and from 37.6 %-49.0 % to 19.1 %-28.5 % for p210. The percentage of laboratories within ± 2-fold of the target values increased from 77.1 %, 76.4 %, 73.2 %, and 74.5 % to 94.3 %, 95.5 %, 92.4 %, and 91.1 % for p190 samples 2023S21-2023S24, and from 72.3 %, 86.2 %, 79.2 %, and 81.1 % to 98.1 %, 99.4 %, 98.1 %, and 96.2 % for p210 samples 2023S11-2023S14. Overall, our study successfully developed and employed p190 and p210 reference materials to promote accuracy and comparability of BCR::ABL1 quantification among laboratories.
:ABL1 的定量监测可用于微小残留疾病的监测，对于患者分层至关重要。虽然在提高 p210 BCR::ABL1 定量检测的准确性方面已经取得了显著进展，但 p190 BCR::ABL1 的定量检测尚未标准化。因此，我们开发了 p190 BCR::ABL1 参考物质，通过创新的质粒校准策略来校准定量过程。然后，我们进一步探索了 p190 和 p210 参考物质在中国 159 家实验室的标准化检测应用，并利用质量评估样本评估了它们的检测能力。结果表明，校准后，p190 的检测结果变异系数从 50.8%-57.4%降至 24.9%-36.4%，p210 的检测结果变异系数从 37.6%-49.0%降至 19.1%-28.5%。在 p190 样本 2023S21-2023S24 中，靶值±2 倍范围内的实验室比例从 77.1%、76.4%、73.2%和 74.5%分别增加到 94.3%、95.5%、92.4%和 91.1%，在 p210 样本 2023S11-2023S14 中，靶值±2 倍范围内的实验室比例从 72.3%、86.2%、79.2%和 81.1%分别增加到 98.1%、99.4%、98.1%和 96.2%。总的来说，我们的研究成功地开发并应用了 p190 和 p210 参考物质，以提高实验室之间 BCR::ABL1 定量检测的准确性和可比性。
