| 摘要: |
| ［摘要］ 目的 验证i-CHROMA Reader免疫荧光分析仪的性能。方法 以C-反应蛋白(C-reactive protein，CRP)作为分析指标，对仪器的精密度、线性、准确度、抗干扰能力进行验证。结果 批内和批间精密度分别为2.60%和3.66%，1.76%和3.34%；线性实验显示方程为Y=1.0128X+0.445，相关系数（r）=0.996；准确度实验i-CHROMA Reader免疫荧光分析仪与Roche ISE-D-P模块检测结果一致性较好(偏倚为4.52%)；黄疸和乳糜干扰物对测试结果的影响度分别为-4.9%～2.45%和-4.22～2.71%。结论 该分析仪的性能指标达到厂商声明的性能，能满足实验室的实验要求，可用于临床标本的检测。 |
| 关键词: 免疫荧光分析仪 C-反应蛋白 性能验证 |
| DOI：10.3969/j.issn.1674-3806.2012.07.16 |
| 分类号:R 446.6 |
| 基金项目: |
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| Verification of the performance of the i-CHROMA Reader immunofluorescence analyzer |
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DOU Li-Ling, DONG Jia-shu
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Department of Laboratory, the Fourth Affiliated Hospital of Guangxi Medical University,Liuzhou 545005,China
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| Abstract: |
| ［Abstract］ Objective To verify the performance of the i-CHROMA Reader immune fluorescence analyzer.Methods C-reactive protein (CRP) was taken as an analytical indicator, precision, linearity, accuracy, anti-jamming capability of the instrument was verified.Results The precision of inner batch and inter- batches were 2.60% and 3.66%, 1.76% and 3.34%, respectively. The linear experiments showed that the equation Y=1.0128X+0.445 and correlation coefficient r=0.996. The accuracy of experiment showed that the i- CHROMA Reader immunofluorescence analyzer was in accordance with Roche ISE-D-P module in test results (bias 4.52%); the effects of jaundice and chylous disruptors on the test results were -4.9%～2.45% and -4.22 ～ 2.71% respectively.Conclusion The performance of the instrument is in accordance with what is declared by manufacturers, meeting the requirements of this laboratory, which can be used for the detection of clinical specimens. |
| Key words: Immunofluorescence analyzer C-reactive protein(CRP) Performance verification |
