ELISA试剂加样后比色程序的应用探讨

Application of ELISA reagent in the process of color comparison

目的探讨抗-HCV ELISA试剂在稀释液加标本后进行比色程序设置的CUT OFF值的适宜性和比色程序的必要性。方法运用Liswell实验室软件,对不同血清标本(正常、脂浊、溶血)和质控品标本用抗-HCV ELISA试剂进行加样分析,观察其吸光度变化和CUT OFF值。使用L-J质控图对不同批号的试剂、质控标本的吸光度设置质控框架。结果不同状态的血清标本、质控品比色OD值差异较大,正常标本、脂浊、溶血标本、质控品标本的OD均值分别为0.812、0.923、0.864、0.442。加样后比色环节对不同批号的试剂使用相同的质控品,批间无明显差异,CV值均<3%,应用L-J质控图可以预防和纠正加样偏差。结论微量加样的ELISA试剂应用加样后的比色程序,对血清标本和质控品标本应设置不同的CUT OFF值。

Objective To investigate the suitability of anti-HCV ELISA reagent and the necessity of applying ELISA to the color program at the cut-off value. Methods Using anti-HCV ELISA reagent,Liswell laboratory software was used to analyze different serum samples（ normal,lipid turbidity,hemolysis） and quality control samples. Absorbance changes and cut off values were observed in specimens. L-J quality control chart was used to monitor the change in degrees of absorbance in different reagents. Results Serum samples at different states had larger difference in the colorimetric values. The average normal degrees of absorbance in a normal specimen,with lipid turbidity,hemolysis,and quality control sample were0. 812,0. 923,0. 864,and 0. 442,respectively. After different reagents were added using the same quality control products,no significant difference was noted in the color change,reaching a difference in values 〈 3%. The application of L-J quality control chart can prevent and correct sampling bias. Conclusion The ELISA reagent should set up different cut off values for serum and quality control samples.