China’s first standardized platform for chronic myelogenous leukemia testing completed

    “The establishment of a standardized platform for molecular testing of chronic myeloid leukemia (CML) in China and the successful promotion of the standardization project will bring benefits to more patients with CML.” Professor Huang Xiaojun, director of the Institute of Hematology, Peking University People’s Hospital, said in an interview with Science and Technology Daily that “monitoring” is very important for the treatment of slow particles. However, there is no unified test reagent and unified test method, and the report is not uniform. “Therefore, the establishment of a standardized detection system is very important.”      It is understood that due to different testing methods and different testing reagents, the results of genetic tests related to slow particles cannot be mutually recognized between various medical institutions in China. For this reason, the Institute of Hematology at Peking University Hospital led a project to standardize multi-polymerase chain reaction (PCR) testing for patients with slow granulocytes in China. The Institute has recently successfully achieved sample interchange with the international reference laboratory, the Adelaide Laboratory in Australia, and successfully obtained a valid inter-laboratory conversion factor (CF), which marks the Institute as the first standardized platform for slow-grain testing in China and lays the foundation for promoting standardization and internationalization of slow-grain-related genetic testing in China. .       “In China, 13 out of every 100 leukemia patients are slow granule patients.” Huang Xiaojun revealed that once patients develop slow granules, they can be treated with medication that makes life unaffected by the disease. However, patients during treatment need to be closely monitored for efficacy in order to clarify the stage of treatment and evaluate its effectiveness.       Huang explained that international guidelines identify major molecular remission (MMR) as the ideal therapeutic target for slow granules, consider that only PCR testing can detect residual slow granule-specific genes (BCR-ABL), and use molecular monitoring using PCR every 3 months as an indicator for treatment evaluation. China has been testing for BCR-ABL since 2000, but there has been no unified testing reagents and unified testing methods across the country. Patients who turn to the doctor not only have to spend money on repeated testing (each test costs 500-600 RMB), but also have difficulty getting accurate and stable testing services.       The PCR standardization project for CML patients in China, which started in 2010, was jointly implemented by 10 hospitals, including Peking University People’s Hospital, Union Hospital of Wuhan University, Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University, and Guangdong Provincial People’s Hospital, with Peking University People’s Hospital as the “benchmark” and the other 9 hospitals conducting So far, the results have been compared 5 times, and the results show that the experimental techniques of each hospital have become mature and stable. At present, the calibration of the testing technology of the above 10 hospitals is as follows: Patients’ samples are collected by Peking University People’s Hospital, each sample is divided into 10 copies, one copy is kept by Peking University People’s Hospital for testing, and the other 9 copies are distributed to the other 9 hospitals, and the test results are summarized to Peking University People’s Hospital for calibration after each test.       It is reported that the preliminary results of the standardized platform for PCR monitoring in China have been achieved. The project plans to add 10 more Chinese CML patient PCR standardization project monitoring centers in 2013.