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目的比较分析国产和进口2种EIA-HIV试剂对无偿献血者HIV1/2初筛结果的差异,探究减少1遍酶免检测的可行性。方法收集嘉兴市2009-2014年无偿献血者2种EIA-HIV1/2初筛试验阳性结果和WB法确认试验的检测数据,分析初筛试验与确认试验结果之间的关系;分析研究初筛试验S/CO值和确认试验结果间的关联性。结果国产和进口试剂的HIV阳性检出率分别为9.58/万和12.43/万,确认阳性预测值分别11.84%和9.12%,两者比较无统计学意义(χ~2=1.11,P>0.05);国产和进口联合检出阳性率为1.37/万,确认阳性预测值为82.86%,与单一试剂检测结果比较,均有差异性(χ~2国产=94.04,P<0.05和χ~2进口=124.86,P<0.05);S/CO值≥6.0时,国产和进口阳性预测值分别为93.55%(29/31)和87.50%(28/32)。结论国产和进口试剂EIA-HIV1/2之间无差异性。
OBJECTIVE: To compare the differences of HIV1 / 2 screening results of two types of EIA-HIV reagents made in China and those of non-free blood donors and explore the feasibility of reducing the number of enzyme-free tests by 1 times. Methods The positive results of two primary screening tests of EIA-HIV1 / 2 in 2009-2004 blood donors in Jiaxing City were collected and the test data of WB confirmation test were collected to analyze the relationship between the preliminary screening test and the confirmation test results. Correlation between S / CO values and confirmed test results. Results The positive rates of HIV positive tests of domestic and imported reagents were 9.58 / million and 12.43 / 10000, respectively. The positive predictive values were 11.84% and 9.12%, respectively. There was no significant difference between the two (χ ~ 2 = 1.11, P> 0.05) ; The positive rate of domestic and imported joint detection was 1.37 / million, the positive predictive value was 82.86%, which was different from the single reagent test results (χ ~ 2 domestic = 94.04, P <0.05 and χ ~ 2 import = 124.86, P <0.05). For S / CO value≥6.0, the positive predictive value of domestic and imported were 93.55% (29/31) and 87.50% (28/32), respectively. Conclusion There is no difference between domestic and imported reagent EIA-HIV1 / 2.