全自动酶联免疫检测仪与手工酶联免疫检测的比对评价

Comparative evaluation on detection of automatic enzyme instrument and manual enzyme detection

目的评价Tecan Freedom Evolyzer-2200全自动酶联免疫仪与手工操作后BIO-RAD680酶标仪检测临床标本结果的一致性。方法用高浓度的乙型肝炎表面抗原(HBsAg)了解仪器的交叉污染情况,采用1IU/mL的HBsAg质控血清检测其孔间重复性和板间重复性,随机抽取50份临床标本经该仪器和手工加样操作BIORAD680酶标仪测定乙型肝炎病毒5项指标,测定结果进行比对。结果经试验该酶联免疫仪器的拖带污染在低水平,与手工操作比对50个项目指标检测结果总的符合率达96.4%。结论该仪器可以满足临床实验需要。

Objective To evaluate the consistency of the detection results of clinical specimen by the Tecan Freedom Evolyzer-200 fully automatic enzyme instrument and the BIO-RAD680 with manual operation. Methods The high concentration of hepatitis B surface antigen（HBsAg） was adopted to understand the cross contamination situation of the instrument, 1 IU/mL HBsAg quality-control serum was adopted to detect the repeatability among holes and among plates. The random 50 clinical specimens were detected the 5 indexes of the liver function by this in- strument and BIO-RAD680 enzyme-labelling instrument with manual sample-adding, the determination results were conducted the comparison. Results By testing, the towing pollution of this enzyme immunoassay instrument was in the low level,comparing the 5 indexes of hepatitis B in 50 clinical specimens measured by the manual operation, the total coincidence rate was 96.4%. Conclusion This instrument can meet the needs of the clinical trials.