改良MONICA质控图在ELISA质控中的应用

Application of Modified MONICA Quality Control Chart in ELISA Quality Control

〔目的〕寻找ELISA法检测项目更好的质量控制方法。〔方法〕使用做OCV时取得的OD/CO均值作为靶值,以30%作为CCV,建立改良MONICA质控图控制线;观察RCV的变化并比较做OCV时取得的OD/CO均值和做RCV时取得的OD/CO均值的差异,并对使用"即刻法"质控、Levey-Jennings质控和改良MONICA质控的结果进行分析。〔结果〕13对做OCV时取得的OD/CO均值和做RCV时取得的OD/CO均值的差异大都在10%以内;13次检测结果的RCV相差较大,最小为9.20%,最大为15.88%,均值为12.26%,这直接影响了使用Levey-Jennings质控和"即刻法"质控时质控结果的质控状态,而使用改良MONICA质控时,其失控线不受每次RCV结果的影响。〔结论〕在ELISA质控中使用改良MONICA质控优于Levey-Jennings质控和"即刻法"质控。

Objective To search for a good way to implement ELISA Quality Controls. Methods To establish the modified Monica Quality Control chart with the target value of the OD/CO mean acquired when the OCV was done with a CCV of 30%. To study the variation of RCV and compare the OD/CO means acquired when the OCV were done with the OD/CO means acquired when the RCV were done, the results of the Quality Control with ＂Instant Method＂ ,Levey-Jennings and modified Monica were analyzed. Results The differences between the 13 pairs of OD/CO means acquired were mostly less than 10% when the OCV was done and acquired than when the RCV was done. The differences between the 13 results of RCV were obvious. The least was 9.2%,while the largest was 15.88% ,and the mean was 12.26%. This directly influenced the Quality Control status of the Quality Control results using both the ＂Instant Method＂ and the Levey-Jennings Methods,but the out control lines were not influenced by the results of each RCV when using the modified Monica Quality Control. Conclusion Using the modified Monica Quality Control is better than using either the Levey-Jennings Quality Control method or the ＂Instant Method＂ Quality Control in ELISA.