摘要:目的  比较两种酶法测定血清游离脂肪酸试剂盒的分析性能。方法  分别应用国产与进口两种血清游离脂肪酸检测试剂盒，通过雅培c8000全自动生化分析仪测定50份体检样本血清游离脂肪酸浓度，进行精密度、准确度、抗干扰和线性试验等分析性能的评价与比较。结果 ① 精密度分析结果：国产试剂的批内CV%为7.6%、5.8%，批间CV%为9.6%；进口试剂的批内CV%为0.7%、2.8%，批间CV%为2.2%。② 平均回收率结果：国产试剂平均回收率为100.3%，进口试剂为97.76%，两者差异无统计学意义 (P>0.05)。③ 线性范围分析结果：在3.11mmol/L内，国产试剂测定血清游离脂肪酸线性相关性良好；在3.23mmol/L内，进口试剂线性相关性良好，且两者差异无统计学意义 (P>0.05)。④ 干扰试验分析结果：在血红蛋白<0.12mmol/L，胆红素<0.34mmol/L，甘油三酯<11.3mmol/L,维生素C<1.2mmol/L条件下， 两种试剂盒测定血清血清游离脂肪酸的结果之间无显著差异(P>0.05)。⑤ 对临床血清游离脂肪酸测定结果分析表明，两种试剂相关性好(Y_九强=0.9667X_德赛+0.0175，R²=0.9801，P<0.05，n=50)，偏差无统计学差异(P>0.05)。结论  国产与进口试剂盒检测血清游离脂肪酸结果一致性较好，且CV%均小于10%。国产试剂精密度相对较低，线性可达到3.11mmol/L，抗干扰能力较强。该结果表明两种试剂盒的分析性能无明显差异，具有较好可比性。

Abstract：Objective To study analytical performance of domestic serum free fatty acid (FFA) detection kits. Methods Two domestic serum free fatty acid detection kits were chosen to detect concentration of FFA in pooled serum specimens and the samples were also measured by Abbott c8000 Automatic Biochemistry Analyzer to evaluate the linearity, precision, accuracy, and interference of the two kits. Results The interassay coefficient variation (CV) of two domestic reagent were 7.6% and 5.8%, and the intraassay CV was 9.6 % ; while the interassay CV of foreign reagent were 0.7% and 2.8%, and the intraassay CV was 2.2 %. The average recovery of domestic reagent and foreign reagent were100.3% and 97.76% respectively, there was no significant difference (P>0.05). The analysis of linear range indicated that concentration of FFA within 3.11 mmol/L (domestic kits) and 3.23 mmol/L (foreign kits) had high linear correlation, and the difference had no statistical significance (P>0.05). On the condition of hemoglobin (<0.12mmol/L), bilirubin (<0.34mmol/L), triglycerides(<11.3mmol/L), Vitamin C (<1.2mmol/L), there were no significant effect on quantitative detection of FFA in 50 serum samples detected by both kits, which showed high correlation and low deviation (P>0.05). Conclusion Compare to foreign reagents, domestic reagents has relatively lower precision. They all have high consistency and correlation and no significant difference are found.