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Quality assurance issues in DNA image cytometry.

DNA image cytometry is currently used in many clinical laboratories as a prognostic tool for the study of patients with malignant neoplasms. However, quality assurance (QA) procedures for image cytometry (IC) have not been standardized. National proficiency testing programs for DNA IC are yet to be developed. We describe our QA program for DNA IC. Indicators of quality; thresholds for evaluation; methods for collection, organization, and evaluation of data; and actions recommended to deal with problems are described for each of the phases of DNA IC. They include QA procedures for sample acceptability; staining technique; instrumentation, including linearity and calibration verification; and correlation with other cytometric methods. The difficult problem of standardizing the postanalytical phase of QA is discussed. The need for a consensus conference to adopt standardized QA procedures for DNA image analysis is emphasized.