以质控品浓度为指标的ELISA室内质控方法研究

    杨寿旺，李睿，周振达，黄建可

    温州国际旅行卫生保健中心，浙江温州 325000

   摘要：目的探寻更好的ELISA室内质控方法。方法在每次ELISA试验时，同时检测临界标准品和质控品，依据所测得的临界标准品和质控品的吸光度以及临界标准品的浓度计算出质控品的浓度。根据所得的质控品的浓度计算出其均值作为靶值，以普遍可以接受的CV15%设定控制线，建立Levey-Jennings质控图。结果使用该质控方法不但质控结果变异小，更换试剂批号时无需更换质控图，而且可以直接反映出检测的灵敏度。结论以质控品浓度为指标的ELISA室内质控方法明显优于以OD/CO为指标的ELISA室内质控方法。

    关键词：质量控制；酶联免疫吸附试验；吸光度／临界值；质控图；溯源性；浓度

    中图分类号：R331　文献标识码：B

    Study on ELISA method of internal quality controlwith controls concentration as an indicator

    YANG Shou-wang， LI Rui， ZHOU Zhen-da， HUANGJian-ke

    Wenzhou International Travel Health CareCenter，Wenzhou，Zhejiang 325000，China

    Abstract:   Objective   To explore a bettermethod of ELISA method of internal quality control.   Methods  Critical standard and quality control samples weresimultaneously measured in ELISA test, the concentration of thequality control samples were  calculated using the absorbanceof critical standard and quality control samples and theconcentration of the critical standard. The quality control chartof Levey-Jennings was set using the average value of theconcentration of the quality control samples as target value andusing the widely acceptable CV15 % to set control line.  Results   There were some advantageous such as the lowervariation of control results,did not changing quality control chartwhile using new lot reagents and the sensitivity of the detectioncan be reflected directly.   Conclusion   The ELISAmethod of internal quality control with controls concentration asan indicator is obviously better than using the index ofOD/CO.

    Key words:   Quality control； ELISA；Sample/cut-off absorbance ratio；Levey-Jennings； Traceability；Concentration

    《中国国境卫生检疫杂志》2013年10月刊