Lefebvre R C, Lasater T H, McKinlay S M, Gans K M, Walker N, Carleton R A
Pawtucket Heart Health Program, Division of Health Education, Memorial Hospital of Rhode Island 02860.
Public Health Rep. 1989 May-Jun;104(3):266-70.
Four experiments were conducted to assess the precision and accuracy of the Boehringer Mannheim Diagnostics Reflotron, an instrument that is being adopted by many public health groups to conduct blood cholesterol screening programs. Our study is one of the first to evaluate and document the instrument's performance characteristics. Successive generations of reagent tabs supplied by the manufacturer were tested against a reference laboratory method standardized by the Centers for Disease Control. Three of the experiments also compared two or more Reflotrons to assess intermachine reliability. The Reflotron analyzer provided precise blood cholesterol measurements both in repeated tests and among instruments. The accuracy of the method varied across reagent lots, with an average negative bias of 21.05 milligrams per deciliter (mg per dl), decreasing steadily to a negative bias of 4.07 mg per dl. Reliability between and within analyzers was high. The data provide support for the use of the instrument in blood cholesterol screening efforts, yet signal the need for attention to quality control procedures, both by the manufacturer and operators, to ensure the validity and accuracy of the results.
开展了四项实验，以评估博林格曼海姆诊断公司的Reflotron仪器的精密度和准确性。许多公共卫生组织都采用该仪器开展血液胆固醇筛查项目。我们的研究是首批评估并记录该仪器性能特征的研究之一。将制造商提供的连续几代试剂片与疾病控制中心标准化的参考实验室方法进行对比测试。其中三项实验还对两台或更多的Reflotron仪器进行了比较，以评估仪器间的可靠性。Reflotron分析仪在重复测试以及不同仪器之间均能提供精确的血液胆固醇测量结果。该方法的准确性因试剂批次而异，平均负偏差为每分升21.05毫克（mg/dl），并稳步降至每分升4.07毫克的负偏差。分析仪之间以及分析仪内部的可靠性都很高。这些数据为该仪器用于血液胆固醇筛查工作提供了支持，但也表明制造商和操作人员都需要关注质量控制程序，以确保结果的有效性和准确性。
