Bacus J W, Bacus J V
Quantitative Diagnostic Laboratory, Inc., Elmhurst, IL 60126.
J Cell Biochem Suppl. 1994;19:153-64.
DNA ploidy has become a commonly performed quantitative image cytometry test in microscopic pathology. This has led to the need to develop quality control procedures to aid in assuring uniform and reliable test results. There are a number of unique issues related to the emerging technology of image analysis and its routine use as a quantitative microscopic assay that require consideration before establishing a quality control program. Previous considerations of this topic have primarily related to measurement issues, e.g., accuracy comparisons to other methodologies, calibration of instrumentation, sources of measurement error, and the interpretation of measurements results. Although these issues are critically important, with more routine usage the focus is now turning to quality control of the overall testing process in everyday use. Control charts and methods of controlling the total measurement process such as have been used in clinical chemistry, need to be established. As one of the first image assays in pathology, quality control procedures established now for DNA ploidy measurements could help shape the development of this field, especially as pathology transitions from being a subjective visual microscopic inspection process to a quantitative measurement process. This paper discusses these issues as they relate to overall quality assurance for the DNA ploidy test and describes a quality control program developed for an active breast cancer testing laboratory specializing in image cytometry tests, including DNA ploidy. The quality control program includes calibration control charts, control charts for internal diploid controls, check samples, and computerized individual histogram interpretation.
DNA倍性分析已成为显微病理学中常用的定量图像细胞术检测方法。这就需要制定质量控制程序，以确保检测结果的一致性和可靠性。图像分析作为一种新兴技术及其作为定量显微分析的常规应用，存在一些独特的问题，在建立质量控制程序之前需要加以考虑。此前对该主题的考量主要涉及测量问题，例如与其他方法的准确性比较、仪器校准、测量误差来源以及测量结果的解释。尽管这些问题至关重要，但随着该技术的更广泛应用，目前的重点已转向日常使用中整个检测过程的质量控制。需要建立类似临床化学中使用的控制图和控制整个测量过程的方法。作为病理学中首批图像分析检测之一，目前为DNA倍性测量建立的质量控制程序有助于塑造该领域的发展，尤其是在病理学从主观的视觉显微检查过程向定量测量过程转变的过程中。本文讨论了与DNA倍性检测整体质量保证相关的这些问题，并描述了为一家专门从事包括DNA倍性分析在内的图像细胞术检测的活跃乳腺癌检测实验室制定的质量控制程序。该质量控制程序包括校准控制图、内部二倍体对照控制图、对照样本以及计算机化的个体直方图解读。
