Segondy M, Izopet J, Pellegrin I, Montes B, Dumon B, Pasquier C, Peeters M, Fleury H J, Puel J, Reynes J
Department of Virology and Department of Infectious and Tropical Diseases, Montpellier University Hospital, Montpellier, France.
J Clin Microbiol. 1998 Nov;36(11):3392-5. doi: 10.1128/JCM.36.11.3392-3395.1998.
We compared the QUANTIPLEX HIV-1 RNA 2.0 assay with the AMPLICOR HIV-1 MONITOR 1.0 assay for quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in plasma in the Stadi trail, which evaluated a stavudine plus didanosine combination therapy in 52 patients. HIV-1 RNA baseline values measured with AMPLICOR HIV-1 MONITOR 1.0 were significantly higher than those measured with QUANTIPLEX HIV-1 RNA 2.0, and decreases in HIV-1 RNA levels from baseline were also found to be significantly higher when measured with the AMPLICOR HIV-1 MONITOR 1.0 assay. The frequency of HIV-1 RNA levels below the lower limit of quantitation was significantly higher with QUANTIPLEX HIV-1 RNA 2.0 than with AMPLICOR HIV-1 MONITOR 1.0. Reanalysis of these results by an ultrasensitive procedure of AMPLICOR HIV-1 MONITOR 1.0 or by a modified version of the test that included additional primers adapted for non-B HIV-1 clades yielded greater differences between the QUANTIPLEX HIV-1 RNA 2.0 assay and the AMPLICOR HIV-1 MONITOR 1.0 assay. Our results indicate that a valid comparison of the virological efficacies obtained with different antiretroviral drug regimens requires the use of the same viral load quantitation procedure; further standardization between the different HIV-1 RNA quantitation kits is therefore needed.
在一项针对52例患者评估司他夫定加去羟肌苷联合疗法的Stadi试验中，我们比较了QUANTIPLEX HIV-1 RNA 2.0检测法与AMPLICOR HIV-1 MONITOR 1.0检测法对血浆中人类免疫缺陷病毒1型（HIV-1）RNA的定量检测。用AMPLICOR HIV-1 MONITOR 1.0测得的HIV-1 RNA基线值显著高于用QUANTIPLEX HIV-1 RNA 2.0测得的值；用AMPLICOR HIV-1 MONITOR 1.0检测法测得的HIV-1 RNA水平相对于基线的下降幅度也显著更高。QUANTIPLEX HIV-1 RNA 2.0检测法检测到HIV-1 RNA水平低于定量下限的频率显著高于AMPLICOR HIV-1 MONITOR 1.0检测法。通过AMPLICOR HIV-1 MONITOR 1.0的超灵敏程序或通过包含适用于非B型HIV-1进化枝的额外引物的改良检测版本对这些结果进行重新分析，发现QUANTIPLEX HIV-1 RNA 2.0检测法与AMPLICOR HIV-1 MONITOR 1.0检测法之间的差异更大。我们的结果表明，要对不同抗逆转录病毒药物方案的病毒学疗效进行有效比较，需要使用相同的病毒载量定量程序；因此，不同的HIV-1 RNA定量试剂盒之间需要进一步标准化。
