目的对Roche cobas e 411全自动化学发光分析仪进行性能验证。方法对分析系统进行精密度、准确度、线性试验及携带污染率等指标测试。结果批内精密度CV<4%,批间精密度CV<5%,携带污染率0.13%,线性回归系数0.99。结论 Roche cobas e...目的对Roche cobas e 411全自动化学发光分析仪进行性能验证。方法对分析系统进行精密度、准确度、线性试验及携带污染率等指标测试。结果批内精密度CV<4%,批间精密度CV<5%,携带污染率0.13%,线性回归系数0.99。结论 Roche cobas e 411全自动化学发光分析仪具有良好的线性、准确性和重复性,是临床实验室较理想的免疫分析仪器。展开更多
AIM:To compare the clinical performance of a real-time PCR assay with the COBAS Amplicor Hepatitis B Virus (HBV) Monitor test for quantitation of HBV DNA in serum samples. METHODS: The reference sera of the Chinese Na...AIM:To compare the clinical performance of a real-time PCR assay with the COBAS Amplicor Hepatitis B Virus (HBV) Monitor test for quantitation of HBV DNA in serum samples. METHODS: The reference sera of the Chinese National Institute for the Control of Pharmaceutical and Biological Products and the National Center for Clinical Laboratories of China, and 158 clinical serum samples were used in this study. The linearity, accuracy, reproducibility, assay time, and costs of the real-time PCR were evaluated and compared with those of the Cobas Amplicor test. RESULTS: The intra-assay and inter-assay variations of the real-time PCR ranged from 0.3% to 3.8% and 1.4% to 8.1%, respectively. The HBV DNA levels measured by the real-time PCR correlated very well with those obtained with the COBAS Amplicor test (r = 0.948). The real-time PCR HBV DNA kit was much cheaper and had a wider dynamic range. CONCLUSION: The real-time PCR assay is an excellent tool for monitoring of HBV DNA levels in patients with chronic hepatitis B.展开更多
文摘目的对Roche cobas e 411全自动化学发光分析仪进行性能验证。方法对分析系统进行精密度、准确度、线性试验及携带污染率等指标测试。结果批内精密度CV<4%,批间精密度CV<5%,携带污染率0.13%,线性回归系数0.99。结论 Roche cobas e 411全自动化学发光分析仪具有良好的线性、准确性和重复性,是临床实验室较理想的免疫分析仪器。
文摘AIM:To compare the clinical performance of a real-time PCR assay with the COBAS Amplicor Hepatitis B Virus (HBV) Monitor test for quantitation of HBV DNA in serum samples. METHODS: The reference sera of the Chinese National Institute for the Control of Pharmaceutical and Biological Products and the National Center for Clinical Laboratories of China, and 158 clinical serum samples were used in this study. The linearity, accuracy, reproducibility, assay time, and costs of the real-time PCR were evaluated and compared with those of the Cobas Amplicor test. RESULTS: The intra-assay and inter-assay variations of the real-time PCR ranged from 0.3% to 3.8% and 1.4% to 8.1%, respectively. The HBV DNA levels measured by the real-time PCR correlated very well with those obtained with the COBAS Amplicor test (r = 0.948). The real-time PCR HBV DNA kit was much cheaper and had a wider dynamic range. CONCLUSION: The real-time PCR assay is an excellent tool for monitoring of HBV DNA levels in patients with chronic hepatitis B.
