血管内皮生长因子检测试剂盒质控标准的确定

Determination of quality control standard for detection kit for vascular endothelial growth factor

目的确定血管内皮生长因子(Vascular endothelial growth factor,VEGF)检测试剂盒的质控标准。方法对已制备的VEGF检测试剂盒反应体系的线性范围、最低检出限、精密性、准确性、稳定性进行质量评价,确定质控标准。结果 VEGF检测试剂盒的线性范围为0～400 pg/ml;最低检出限为0 pg/ml;检测不同浓度VEGF样品的批内精密性为9.83%～13.73%,不同时间检测VEGF的批内精密性为5.47%～14.08%,批间精密性为7.88%;检测不同浓度VEGF的回收率为94%～105%,确定试剂盒的质控标准为批内、批间精密性<15%,回收率在90%～110%之间。3批试剂盒于4℃分别放置6个月,各项指标均符合已确定的质控标准。结论已确定了VEGF检测试剂盒的质控标准,为其进一步应用于临床奠定了基础。

Objective To determine the quality control standard for detection kit for vascular endothelial growth factor （VEGF）. Methods The prepared detection kit for VEGF was evaluated for linear range, minimum detection limit, precision, accuracy and stability, based on which the quality control standard was determined. Results The linear range and minimum detection limit of the prepared kit were 0 N 400 and 0 pg / ml respectively. The intra-precision of detection results of VEGF samples at different concentrations and time points were 9. 83% N 13.73% and 5.47% - 14. 08% respectively. However, the inter-precision of detection results was 7. 88%. The recovery rate of VEGF at various concentrations was 94% -105%. The quality control standard for the kit was determined as follows： both the intra- and inter-precisions were less than 15%, and the recovery rate was 90% -110%. After storage at 4℃ for 6 months, all the indexes of the kit met the determined standard. Conclusion The quality control standard for detection kit for VEGF was determined, which laid a foundation of further application of the kit in clinic.