以质控品浓度为指标的ELISA室内质控方法研究

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CVl5％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。

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

Objective To explore a better method of ELISA method of internal quality control. Methods Critical standard and quality control samples were simultaneously measured in ELISA test, the concentration of the quality control samples were calculated using the absorbance of critical standard and quality control samples and the concentration of the critical standard. The quality control chart of Levey-Jennings was set using the average value of the concentration of the quality control samples as target value and using the widely acceptable CV15 % to set control line. Results There were some advantageous such as the lower variation of control results,did not changing quality control chart while using new lot reagents and the sensitivity of the detection can be reflected directly. Conclusion The ELISA method of internal quality control with controls concentration as an indicator is obviously better than using the index of OD/CO.