This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies.
This study aims to evaluate the clinical accuracy of ClearLLab LS screening panel in the diagnosis of hematologic malignancies. The residual specimens, which from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematologic diseases work-up, will be tested by ClearLLab LS screening panel. ClearLLab LS screening panel is CE-IVD marked immunophenotyping reagents under the European Union (EU) regulation, and this study is aimed to validate its clinical performance in Chinese population.
Study Type
OBSERVATIONAL
Enrollment
831
Immunophenotyping of residual clinical samples tested with ClearLLab LS screening panel on a specified Flow Cytometry
Tongji Hospital
Wuhan, Hubei, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China
Diagnostic accuracy: sensitivity and specificity
Diagnostic accuracy measured as sensitivity and specificity of ClearLLab LS screening panel in identifying hematological malignancies and non-malignancies compared with the clinical criteria (WHO guidelines)
Time frame: Baseline
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