Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline
|Publication Date:||1 April 2007|
This document establishes performance guidelines for the flow cytometric immunophenotypic analysis of samples from patients with known or suspected hematolymphoid neoplasia. The World Health Organization (WHO) classification system relies upon morphology, clinical history, immunophenotype, and cytogenetics for diagnosis of hematolymphoid neoplasia. Therefore, immunophenotypic analysis of hematolymphoid neoplasia is crucial for the accurate diagnosis and classification of these complex malignancies. It is not within the scope of this document to recapitulate the criteria used to diagnose leukemias and lymphomas. Readers are referred to Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues (Jaffe ES, Harris N, Stein H, Vardiman JW, eds. Lyon, France: IARC Press; 2001). Because this document is intended primarily for laboratory workers in FCM, it cannot describe all the possible clinical situations in which flow cytometric analysis of leukemia or lymphoma is or is not appropriate.
This document includes guidelines for phenotyping cases of acute and chronic leukemias, non-Hodgkin's lymphomas, plasma cell neoplasms, and myelodysplastic syndromes. The subcommittee recognizes that most of the principles used to approach chronic lymphoid leukemias can also be applied to the study of lymphomas, so these problems are considered together. Special problems unique to the study of non- Hodgkin's lymphomas are treated separately.
At present, there are few agreed-upon standards for precision, accuracy, and interlaboratory comparability of leukemia analysis by FCM. Therefore, it is each laboratory's responsibility to establish instrument performance criteria and staining characteristics for its own specific reagents.