ISO15189认可过程中两种分离胶采样管的质量评价  

Establishment of methods to evaluate the quality of two different separate gel tubes during ISO15189 accreditation

作　　者：吴洪坤[1] 李畅[1] 仲人前[1] 周琳[1] 

机构地区：[1]上海长征医院实验诊断科,上海200003

出　　处：《国际检验医学杂志》2016年第4期463-464,467,共3页International Journal of Laboratory Medicine

基　　金：上海市卫生系统优秀青年人才计划项目(XYQ2011046)

摘　　要：目的探讨建立两种不同的分离胶采样管的质量评价方法。方法以硅化玻璃采血管为标准管,以两种分离胶采样管为测试管,随机收集50例患者血清,利用电化学发光、酶联免疫吸附法、反射发光法、免疫荧光法等方法定量或者定性检测血清中各种临床免疫、临床生化指标,并进行相应的统计分析。结果对于定量项目而言,两种分离胶采样管与标准管相比,检测结果比较差异无统计学意义(P>0.05);对于定性项目而言,两种分离胶采样管与标准管相比,真阳性率和真阴性率比较差异无统计学意义(P>0.05,K>0.75),一致性较好。结论通过使用不同的检测方法和检测项目证明了分别采用两种分离胶采样管不会影响到检测结果的准确性和一致性,初步建立了ISO15189实验室认可过程中该实验室针对外部供应品的质量评价方法。Objective To explore the establishment of methods to evaluate the quality of two different separate gel tubes.Methods An evaluation comparing two separate gel tubes with silicate glass tubes,which are the standard tubes,was performed using data from 50 subjects.The serum samples were assayed for routine chemistry or immunology after centrifugation using the quantitative or qualitative detection methods such as ECL,enzyme-linked immunosorbent assay（ELISA）,reflection luminescence or immunofluorescence.The data were collect for further statistical analysis.Results For quantitative results of the items,the two separate gel tubes,compared with the standard glass tube,there was no significant difference between the test results（P0.05）;for qualitative projects,two separate plastic tube,compared with the standard glass tube,really the positive rate and the true negative rate was no significant difference（P0.05,K0.75）.Conclusion By using different detection methods and test items,it is demonstrated that using two separate gel tube for items assay does not affect the accuracy and consistency of the test results.As a result,the method for external supplies quality assessment is established in the laboratory for ISO15189 quality control.

关 键 词：分离胶采样管 检验前过程 外部供应品 

分 类 号：R446.1[医药卫生—诊断学]