【摘要】 目的:探讨ELISA试剂盒平衡时间对抗-HCV检测结果的影响;研究抗-HCV灰区献血者再次献血的可行性和必要性。方法:变化试剂盒平衡时间,测定不同平衡时间的S/Co值。对部分灰区标本进行重组免疫印迹试验(RIBA);应用荧光定量-聚合酶链反应(FQ-PCR)检测灰区标本HCVRNA;应用速率法检测灰区和抗-HCV阴性血清ALT。结果:ELISA试剂盒平衡时间在30min内,1NCU/ml抗-HCV质控、抗-HCV灰区标本的S/CO值随着平衡时间的延长而增加(P<0.05),但30min后变化不明显(P>0.05)。32份灰区标本经Murex试剂筛选后的5份标本进行了RIBA检测,结果为2份可疑,3份阴性。FQ-PCR定量检测均为阴性;速率法ALT检测抗-HCV灰区和抗-HCV阴性标本结果分别为(19.20±7.38)U/L、(16.58±7.08)U/L。2者结果均<40U/L,差异有统计学意义(t=1.48,P>0.05)。结论:抗-HCV试剂盒在检测前应先在室温下平衡30min以上,否则会降低标本的S/Co值,影响结果判断;抗-HCV灰区标本ALT检测结果正常;抗-HCV灰区的献血者在核酸检测结果为阴性的前提下可考虑再次献血。更多还原

【Abstract】 Objective:To explore the effect of the ELISA kit balance time on the outcome of the grey zone specimens and the control materials,and study the feasibility of the re-donation among the anti-HCV grey zone donors.Method:The different S/CO values were detected at different balance time of the kit.The anti-HCV grey zone and the positive specimens were detected and corroborated using RIBA.The HCV-RNAs of grey zone specimens were detected using fluorescent quantitative PCR(FQ-PCR).The serum ALT levels of anti-HCV grey zone and the negative specimens were detected using the rate of speed method.Result:The S/CO value of the 1NCU/ml anti-HCV control materials and the anti-HCV grey zone specimens remarkably increased(P <0.05)when the ELISA kits’balance time was set to less than 30minutes,on the other hand,with more balance time on these kits the S/CO value didn’t change significantly(P >0.05).Among the 5grey zone specimens out of 32specimens screened by the Murex reagent,2were suspicious and 3were negative,and the results of FQ-PCR were all negative.The ALT results of the anti-HCV grey zone serum specimens and the anti-HCV negative serum specimens were respectively(19.20±7.38)U/L and(16.58±7.08)U/L,and there was no remarkable statistic difference(t=1.48,P>0.05).Conclusion:The anti-HCV kits should be balanced in room temperature for more than 30 minutes before any detection.The results of the ALT detections on anti-HCV grey zone specimens would be in normal range.The anti-HCV grey zone donors could somehow re-donate when the result of the nucleic acid detection is confirmed to be negative.更多还原