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目的建立ELISA法抗-HCV诊断试剂评价体系,筛选出适合本地区丙肝流行特征的的献血员抗-HCV检测策略。方法采用重组免疫印迹试验(RIBA)对献血员中抗-HCV筛查阳性或处于检测高值阴性的441份血清标本进行确认,选取部分阳性、高值阴性血清,建立抗-HCV ELISA试剂评价体系,并评价8种试剂的灵敏度、特异度和一致率等。结果构建了抗-HCV诊断试剂参考评价体系,其中24份阳性系列血清包含多种RIBA试验阳性条带组合;24份阴性系列血清中有8份属于含干扰物质的高值阴性标本;并建立浓度梯度稀释系列标本用于灵敏度评价。在评价体系中8种抗-HCV ELISA试剂检测一致率分别为83.33%、85.42%、87.50%、87.50%、89.58%、93.75%、89.58%和79.17%,应用双抗原夹心法的6号试剂灵敏度检测值明显高于其他试剂(P<0.05)。结论自制抗-HCV ELISA诊断试剂评价体系适用于实验室日常工作,在制定本地区筛选策略时应充分考虑试剂间的互补性,以保障血液安全。
Objective To establish an evaluation system of anti-HCV diagnostic reagent by ELISA and screen out the anti-HCV detection strategy of blood donors which is suitable for the prevalence of hepatitis C in this area. Methods 441 serum samples positive for anti-HCV screening or negative for high detection in blood donors were confirmed by RIBA, and some positive and negative serum were selected to establish anti-HCV ELISA reagent evaluation system , And evaluated the sensitivity, specificity, and concordance rates of the eight reagents. RESULTS: A reference evaluation system for anti-HCV diagnostic reagent was constructed. 24 positive sera contained multiple RIBA test positive bands, and 8 out of 24 sera negative sera contained high-negative negative samples with interfering substances. Gradient dilution series of specimens for sensitivity evaluation. The coincidence rates of the eight anti-HCV ELISA reagents in the evaluation system were 83.33%, 85.42%, 87.50%, 87.50%, 89.58%, 93.75%, 89.58% and 79.17%, respectively The detection value was significantly higher than other reagents (P <0.05). Conclusion The self-made anti-HCV ELISA diagnostic reagent evaluation system is suitable for routine laboratory work, and should fully consider the complementarity between reagents in the development of screening strategies in the region to ensure blood safety.