血站血液检测实验室ELISA项目性能验证试验建立与探讨

Performance verification experiment for enzyme-linked immunosorbent assay in blood screening laboratory

目的验证血站实验室的酶联免疫吸附方法检测项目的性能。方法在实验室检测系统中验证ELISA项目的重复性、精密度、灵敏度、特异性、符合性、检出限以及抗干扰性。结果检测系统的重复性为100%;各系统批内不精密度均<10%,批间不精密度均<15%;灵敏度、特异性及符合率为100%,2种试剂的检出限分别为0.75 NCU/mL和0.25 NCU/mL;抗干扰性符合试剂说明书要求。结论对ELISA检测项目进行性能验证数据的分析对比,有助于不断改进和提高检测系统性能,保证临床用血安全。

Objective To verificate the performance of enzyme-linked immunosorbent assay(ELISA)in blood screening laboratory.Methods The repeatability,precision,sensitivity,specificity,compliance,detection limit and anti-interference of ELISA items in the laboratory detection system were verified.Results The repeatability was 100%.The intra batch impre-cision of each system was less than 10%,and the inter batch imprecision was less than 15%.The sensitivity,specificity and compliance were 100%,with the minimum detection limits of the two reagents at 0.75 NCU/mL and 0.25 NCU/mL respectively,The anti-interference met the requirements of the reagent manual.Conclusion The analysis of the performance verification data of ELISA test items will help continuously improve the performance of detection system and ensure the safety of clinical blood use.