抗菌肽Sc-ly应用于肌酐酶法检测试剂盒性能分析

Analysis of performance of creatinase enzymatic test kit appling antimicrobial peptide Sc-ly

目的分析抗菌肽Sc-ly应用于肌酐酶法检测试剂盒,考察其对试剂盒储存稳定性、抑菌效果的影响,并对试剂性能进行评价。方法通过37℃储存稳定性试验、加菌试验考察检测试剂储存稳定性和抑菌效果,并对检测试剂线性范围、精密度进行统计分析,与对照试剂比较相关性,分析其准确性。结果抗菌肽Sc-ly应用于肌酐酶法检测试剂盒储存稳定性良好,37℃储存21d,检测质控品偏差小于5%;37℃放置10d,对Escherichia coli、Staphylococcus aureus、Bacillus subtilis表现良好抑菌作用。试剂盒在0~1 800μmol/L具有良好线性,Y=0.992 3 X-2.722 7,R2=0.999 0,批内精密度和天间精密度CV均小于5%。与对照试剂比较,回归方程为Y=0.988 4 X+0.944 1,R2=0.998 6,显现良好的相关性,测定结果准确可靠。结论抗菌肽Sc-ly应用于肌酐酶法检测试剂,试剂具有良好的储存稳定性和抑菌作用,且试剂盒主要性能指标良好。

Objective To analyze the creatinine enzymatic test kit appling antimicrobial peptide Sc-ly and investigate its effect on storage stability and antimicrobial effect and evaluate the performance of the kit.Methods The storage stability and antimicrobial effect of the test kit was investigated by storage stability test at37℃and by adding bacteria test.The linear range and precision of test kit were analyzed statistically,and the accuracy was analyzed by compared with the control kit.Results The storage stability of creatinase test kit appling the antimicrobial peptide Sc-ly was good.The deviation of detection of quality control products was less than 5%after stored at 37℃for 21 d.The kit had good antimicrobial effect on Escherichia coli,Staphylococcus aureus and Bacillus subtilis after placed at 37 ℃for 10 d.The kit had good linearity between 0 and1 800μmol/L,Y=0.992 3 X-2.722 7,R^2=0.999 0.The intra-batch and inter-day precision CV were less than 5%.The regression equation was Y=0.988 4 X+0.944 1,R^2=0.998 6.The test kit shows correlation well with the control kit,and the results were accurate and reliable.Conclusion Antimicrobial peptide Sc-ly can be used in creatinase assay kit,which has good storage stability and antimicrobial effect,and the main performance is good.