CAJ | 학술논문

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1 IU/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BIO-RAD680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。
목적：평개 Tecan Freedom Evolyzer-2200전자동매련면역의여수공조작후BIO-RAD680매표의검측림상표본결과적일치성。방법용고농도적을형간염표면항원（HBsAg ）료해의기적교차오염정황，채용1 IU/mL적HBsAg질공혈청검측기공간중복성화판간중복성，수궤추취50빈림상표본경해의기화수공가양조작BIO-RAD680매표의측정을형간염병독5항지표，측정결과진행비대。결과경시험해매련면역의기적타대오염재저수평，여수공조작비대50개항목지표검측결과총적부합솔체96．4％。결론해의기가이만족림상실험수요。
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 .