Vice Director of Beijing Ludaopei Hematology Research Institute
Deputy Director of the Laboratory Department at Hebei Yanda Ludaopei Hospital and Beijing Ludaopei Hospital
From June 8 to 12, 2023, the 28th European Hematology Association (EHA) Congress will be held in Frankfurt, Germany, bringing together experts and scholars from around the world to present exciting advances in research. In the field of hematology testing, multi-parameter flow cytometry (MFC) is an important clinical diagnostic method, and the development of fast, simple, and efficient protocols is essential for this technology. A real-world study (P588) conducted by Dr. Hui Wang’s team from Hebei Yanda Ludaopei Hospital and Beijing Ludaopei Hospital has been selected for presentation at EHA. The study aims to introduce the research achievements of Ludaopei Hospital over the years: a rapid, simple, and efficient MFC test for screening and diagnosing malignant tumors and related diseases. To gain a deeper understanding of this research, “Oncology Insight” invited Professor Wang Hui to provide a detailed analysis, which is summarized below.
The sensitivity of tumor cell detection was 10^-4, with nearly 100% coverage and specificity. The false positive rate and false negative rate were both close to 0. Among malignant tumor cases, only one case of CD56-negative epithelial metastatic cancer was not covered, but non-hematopoietic cells were identified through CD45/SSC because of a 10% proportion, avoiding misdiagnosis. Although some cases require additional antibodies for subtype diagnosis and specific diagnosis after tumor identification, mainly in lymphomas, solid tumors, and rare diseases such as blastic plasmacytoid dendritic cell neoplasm (BPDCN) and mast cell tumors, the proportion requiring additional diagnostic antibodies decreased by 23% compared to the previous method, which used a guiding tube with 5-6 additional tubes on average from a base of 40 antibodies. With the same number of specimen tests, manpower was reduced by 33%. The probability of additional antibody testing after initial analysis and diagnosis by junior staff with 5-8 years of experience decreased from an initial 5%-10% to below 1%. This invention is an important testing and analysis protocol that improves efficiency, reduces costs, and lowers misdiagnosis rates for the entire clinical diagnostic field.
Researchers’ Remark
MFC is a crucial tool for detecting and screening malignant tumors, premalignant conditions, genetic immunological disorders, and related clonal and immunological diseases. Three-laser eight to ten-color models can achieve sensitivities of 10^-3 to 10^-4, covering the vast majority of abnormalities. However, protocol diversity makes this work complex, reliant on personnel expertise, and challenging to standardize, automate, or make intelligent. We have designed an efficient and simple protocol, along with corresponding software analysis methods, with the hope of advancing the work of our peers and laying a solid foundation for the future development of laboratory standardization and artificial intelligence.
