CAJ | 학술논문

目的评价乙型肝炎病毒表面抗原(HBsAg)、梅毒螺旋体抗体(TP抗体)和人类免疫缺陷病毒抗体(HIV抗体)胶体金联合检测试剂的检测灵敏性、特异性和重复性,以及应用于献血筛查的意义.方法采用胶体金联合检测试剂分别对2 250份正常献血者血液标本、85份HBsAg阳性标本,78份TP抗体阳性标本和62份HIV抗体阳性标本进行检测,并与参比试剂检测结果进行比较.结果胶体金联合检测试剂与TP抗体参比试剂的总符合率、灵敏度(阳性符合率)和特异性(阴性符合率)分别为99.87%,100%和99.87%;与HBsAg参比试剂的总符合率、灵敏度和特异性分别为99.82%,94.74%和99.87%,与HIV抗体参比试剂的总符合率和特异性为100%,各项检测结果差异均无统计学意义(χ2=0.36,P>0.05;χ2=0.09,P>0.05;χ2=0.08,P>0.05).胶体金联合检测试剂实验重复性阳性符合率为100%.结论胶体金联合检测试剂具有反应速度快,操作更加简单和快捷、灵敏度高、特异性和重复性好,适用于献血前血液筛查.
목적 평개을형간염병독표면항원(HBsAg)、매독라선체항체(TP항체)화인류면역결함병독항체(HIV항체)효체금연합검측시제적검측령민성、특이성화중복성,이급응용우헌혈사사적의의.방법 채용효체금연합검측시제분별대2 250빈정상헌혈자혈액표본、85빈HBsAg양성표본,78빈TP항체양성표본화62빈HIV항체양성표본진행검측,병여삼비시제검측결과진행비교.결과 효체금연합검측시제여TP항체삼비시제적총부합솔、령민도(양성부합솔)화특이성(음성부합솔)분별위99.87%,100%화99.87%;여HBsAg삼비시제적총부합솔、령민도화특이성분별위99.82%,94.74%화99.87%,여HIV항체삼비시제적총부합솔화특이성위100%,각항검측결과차이균무통계학의의(χ2=0.36,P>0.05;χ2=0.09,P>0.05;χ2=0.08,P>0.05).효체금연합검측시제실험중복성양성부합솔위100%.결론 효체금연합검측시제구유반응속도쾌,조작경가간단화쾌첩、령민도고、특이성화중복성호,괄용우헌혈전혈액사사.
Objective To evaluate method sensitivity, specificity and repeatability of the hepatitis B virus surface antigen (HBsAg), Treponema pallidum Antibody (TP antibody) and human immunodeficiency virus antibody (HIV antibody) colloidal gold joint detection reagent and their application significances for blood donation screening. Methods 2 250 blood samples of normal blood donors, 85 samples of HBsAg positive, 78 samples of TP-positive and 62 samples of HIV antibody positive were detected by the colloidal gold reagent respectively, and with reference reagent test results were compared. Results Compared with TP antibody reference reagents, total coincidence rate, sensitivity (the positive coincidence rate) and specificity (negative coincidence rate) of the colloidal gold joint detection reagent were 99. 87% , 100% and 99.87% respectively, and with HBsAg reference reagents were 99. 82%, 94. 74% and 99. 87% respectively. Compared with HIV antibody reference reagents, the total consistent rate and specificity were both 100%. There were no statistical differences between the results of the colloidal gold reagent and the reference reagents(χ2 = 0. 36, P>0.05; χ2 =0.09, P>0.05;χ2 =0. 08, P>0. 05). Experimental repeatability and positive coincidence rate of colloidal gold reagent were 100%. Experimental repeatability and positive coincidence rate were 100%. Conclusion All the results showed here suggest that the quality of the colloidal gold joint detection reagent with high sensitivity, specificity and reproducibility are approaching the level of the reference reagents. The colloidal gold joint detection reagent with reaction of rapid, more simple and fast is suitable for screening blood donors.