国产高精度乙肝病毒载量检测的临床应用评价

The clinical application evaluation of high-sensitive HBV viral load detection with domestic reagent

目的:比较国产上海浩源高精度乙肝病毒定量系统与罗氏COBAS Ampliprep/COBAS TaqMan 48定量系统检测乙肝病毒载量的一致性,评价国产乙肝病毒定量系统的临床适用性。方法:收集2019年3月~5月在我院检测高精度HBV-DNA的患者血清样本,采用国产浩源和罗氏高精度乙肝定量系统分别测量样本浓度,通过Kappa值、R^(2)值和临床可接受范围评价两种检测系统的相关性。结果:以罗氏结果为标准,浩源结果的阳性符合率95%,阴性符合率75%,总符合率93%,Kappa值为0.794,与罗氏结果一致性良好;两种检测系统结果呈线性相关(y=0.954x+0.185,R^(2)=0.951,P<0.01);乙肝病毒载量≥2×10^(1) IU/ml且两种试剂都有定量值时,浩源与罗氏结果偏差≤±0.4Log范围内,一致性为73%;病毒载量高于1×10^(3) IU/ml时,浩源与罗氏结果偏差≤±0.4Log范围内,一致性为79.5%。结论:浩源与罗氏高精度乙肝定量检测系统具有较好的一致性,国产高精度乙肝定量系统可满足临床需要。

Objective:To compare the consistency of Shanghai Haoyuan high-sensitive HBV quantitative system and Roche COBAS Ampliprep/COBAS TaqMan 48 in detecting HBV viral load,and to evaluate the clinical applicability of domestic HBV quantitative system.Methods:Serum samples of patients with high-sensitive HBV-DNA detected in our hospital from march to May 2019 were collected,and the concentration of samples was measured by Haoyuan and Roche high-sensitive HBV quantitative system,respectively.The correlation between the two detection systems was evaluated by Kappa value,R^(2)value and clinically acceptable range.Results:Taking Roche results as the standard,the positive coincidence rate of Haoyuan results was 95%,the negative coincidence rate was 75%,the total coincidence rate was 93%,and the Kappa value was 0.794,which was in good agreement with Roche results.The results of the two detection systems were linearly correlated(y=0.954x+0.185,R^(2)=0.951,P<0.01).When the viral load of HBV was≥2×10^(1) IU/ml and both reagents had quantitative values,the deviation between Haoyuan and Roche results was less than or equal to±0.4Log,and the consistency was 73%.When the viral load was higher than 1×10^(3)IU/ml,the deviation between the results of Haoyuan and Roche was less than±0.4Log,and the consistency was 79.5%.Conclusion:Haoyuan and Roche's high-sensitive HBV quantitative detection system had a good consistency,and domestic high-sensitive HBV quantitative system can meet the clinical needs.