进口ELISA试剂在检测献血者HBsAg中的应用及评价

The preliminary application and evaluation of imported ELISA reagent in detecting HBsAg of blood donors

目的对进口酶联免疫吸附试验(ELISA)试剂检测乙型肝炎病毒表面抗原(HBsAg)的应用效果进行评价,探究减少1次ELISA检测的可行性。方法将2019年9月至2020年7月105737份无偿献血标本用国产和进口ELISA试剂进行HBsAg平行检测,对结果为单试剂有反应性的标本做核酸检测,以国产试剂作为比较试剂,核酸检测作为确认方法,利用统计学方法分析进口ELISA试剂的复检符合率、阳性率和单试剂阳性标本的阳性预测值。结果国产试剂和进口试剂的复检符合率分别为27.42%和51.79%,阳性率分别为0.30%和0.46%,差异均有统计学意义(χ^(2)=12.597,P<0.05;χ^(2)=36.921,P<0.05);国产试剂和进口试剂的阳性预测值分别为5.88%和4.26%,差异无统计学意义(χ^(2)=0.098,P>0.05)。结论进口试剂的假阳性率和国产试剂相当,但其稳定性和灵敏度明显优于国产试剂;国产试剂和进口试剂仍具有一定程度的互补性,如血清学检测只用进口试剂做1次ELISA检测,存在漏检的可能。

Objective To evaluate the application effect of imported enzyme-linked immunosorbent assay(ELISA)reagent in the detection of hepatitis B surface antigen(HBsAg),and explore the feasibility of reducing one time enzyme-linked immunosorbent assay.Methods From September 2019 to July 2020,105737 samples of unpaid blood donors were used for HBsAg parallel detection with domestic and imported ELISA reagent,and the single reagent reactive samples were tested for nucleic acid.Domestic reagent was used as comparison reagent and nucleic acid test was used as confirmation method,statistical methods was used to analyze the coincidence rate,positive detection rate and positive predictive value of single reagent positive samples.Results The retest coincidence rates of domestic and imported reagent were 27.42%and 51.79%respectively,and the positive detection rates were 0.30%and 0.46%respectively,with statistically significant differences(χ^(2)=12.597,P<0.05;χ^(2)=36.921,P<0.05).The positive predictive values were 5.88%and 4.26%respectively,with no significant difference(χ^(2)=0.098,P>0.05).Conclusion The false positive rate of the imported reagent is similar to that of the domestic reagent,but the stability and sensitivity of the imported reagent are obviously better than those of the domestic reagent.Domestic reagent and imported reagent are still complementary to a certain extent,if the serological test only used imported reagent to do one time ELISA test,there is the possibility of missed detection.