国产实时荧光定量核酸检测试剂测定HIV病毒载量

Detection of HIV viral loads by domestic fluorometric diagnostic kit

目的在目前进口试剂较昂贵的情况下,探讨国产实时荧光定量核酸检测试剂用于检测艾滋病病毒(HIV)病毒载量的可行性。方法2004年从全国4个省的HIV感染者/艾滋病(AIDS)患者采集110份样本,每份样本均同时使用生物梅里埃公司NASBA与深圳匹基生物公司实时荧光定量PCR两种方法测定血浆中HIV RNA含量,比较两种方法所得数据间的关系。结果HIV样本病毒载量处于3.5×103-1.0×105拷贝/ml范围时,一致性较好,存在一定线性关系;在小于103拷贝/ml范围内时,两种方法检测结果基本一致;当病毒载量处于1.0×103-3.5×103拷贝/ml范围时,两种方法检测结果偏差较大;病毒载量处于大于105拷贝/ml的范围时,虽然两种检测方法数值之间无相关性,但均显示处于105以上的较高数值范围。结论NASBA与实时荧光定量PCR两种检测方法在3.5×103-1.0×105拷贝/ml范围内有着高度的相关性,国产实时荧光定量核酸检测试剂检测结果与国际上较常用的病毒载量检测方法的结果之间的差异已经缩小,在低载量的检测敏感性还需要进一步优化。总体来说,使用国产实时荧光定量核酸检测试剂可以初略定量血浆中HIV RNA含量。

Objective To evaluate the feasibility of using domestic HIV PCR fluormetric diagostic kit to detect HIV viral loads as an attempt to substitute currently used expensive imported reagents. Method One hundred and eleven plasma samples were collected from 4 provinces in China and were used to monitor RNA viral load level. The reagents that were produced by Biomerieux（NASBA method） and P G biotechnology（real-time quantitative PCR） were simultaneously used to monitor plasma viral loads, and the correlation of these two reagents were analyzed. Results When viral loads ranged from 3.5 × 10^3 to 1.0 ×10^5 copies/ml, the correlation between these two reagents was dose; however, their results were not consistent when viral loads ranged from 1.0 × 10^3 to 3.5 × 10^3 copies/ml.When viral loads were beyond 1.0 × 10^5 copies/ml, the results of these two reagents were consistent even without close correlation between them Conclusion In general, the reagent from PG biotechnology is effective in detecting HIV plasma viral load level when the viral load is beyond 3.5 × 10^3, however its sensitivity needs to be improved when the viral load is lower than 3.5 × 10^3.