关键词: 西格玛性能验证图, 全自动化电化学发光分析仪, 全自动化酶免疫发光分析仪, 性能评价

Abstract: Objective To explore the application of sigma performance verification diagram （SPVD） to evaluation of Roche and Beckman automatic biochemical analyzers. Methods The data of indoor and external quality control of ten items were collected, including AFP, tPSA and fPSA, CEA, CA199, CA125, CA153, iron, protein, total beta HCG, and free estriol. The SPVD of the above markers was prepared based on the detections of Roche and Beckman analyzers, using the CV estimated in the laboratory, percentage difference as bias estimates, and TEa provided by NCCL and the Health Industry Standards. Results Two of the 4 external quality evaluation items provided by Roche analyzer detections were found to have poor results and one was qualified before improvement. After improvement, however, all of the 4 items showed excellent results. For Beckman biochemical analyzer, eight items of external quality assessment were close to the critical value and the quality of 3 items was not acceptable before improvement. The quality of eight items was still in the vicinity of critical point although it seemed to be improved after improvement. Conclusion The detection performance of Roche e602 analyzer appears to be superior to that of Beckman DXI 800, and sigma performance verification diagram may distinctively demonstrate the quality of detections.

Key words: Sigma performance verification diagram, Automatic electrochemical luminescence analyzer, Automated enzyme immunoluminescence analyzer, Performance evaluation