Department of Pathology and Laboratory Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Arch Pathol Lab Med. 2012 Jan;136(1):33-40. doi: 10.5858/arpa.2011-0136-OA.
Monitoring minimal residual disease by quantitative reverse transcription polymerase chain reaction has proven clinically useful, but as yet there are no Food and Drug Administration-approved tests. Guidelines have been published that provide important information on validation of such tests; however, no practical examples have previously been published.
To provide an example of the design and validation of a quantitative reverse transcription polymerase chain reaction test.
To describe the approach used by an individual laboratory for development and validation of a laboratory-developed quantitative reverse transcription polymerase chain reaction test for BCR-ABL1 fusion transcripts.
Elements of design and analytic validation of a laboratory-developed quantitative molecular test are discussed using quantitative detection of BCR-ABL1 fusion transcripts as an example.
Validation of laboratory-developed quantitative molecular tests requires careful planning and execution to adequately address all required analytic performance parameters. How these are addressed depends on the potential for technical errors and confidence required for a given test result. We demonstrate how one laboratory validated and clinically implemented a quantitative BCR-ABL1 assay that can be used for the management of patients with chronic myelogenous leukemia.
通过定量逆转录聚合酶链反应监测微小残留疾病已被证明具有临床应用价值，但目前尚无获得食品和药物管理局批准的检测方法。已经发布了指南，提供了关于此类检测验证的重要信息；然而，以前没有发表过实际的例子。
提供设计和验证定量逆转录聚合酶链反应检测的示例。
描述单个实验室开发和验证实验室开发的用于 BCR-ABL1 融合转录本的定量逆转录聚合酶链反应检测的方法。
使用定量检测 BCR-ABL1 融合转录本作为示例，讨论了实验室开发的定量分子检测的设计和分析验证要素。
实验室开发的定量分子检测的验证需要精心规划和执行，以充分解决所有必需的分析性能参数。如何解决这些问题取决于技术错误的可能性和对特定测试结果的信心。我们展示了一个实验室如何验证和临床实施一种定量 BCR-ABL1 检测方法，该方法可用于慢性髓性白血病患者的管理。
