Gottesman Bat Sheva, Grossman Zehava, Lorber Margalit, Levi Itzchak, Shitrit Pnina, Katzir Michal, Shahar Eduardo, Gottesman Giora, Chowers Michal
Infectious Diseases Unit, Meir Hospital, Sapir Medical Center, Kfar Saba, Israel.
J Med Virol. 2006 Jul;78(7):883-7. doi: 10.1002/jmv.20653.
In facing global programs for treating HIV-infected patients in the developing countries, there is a real need for viral load assays that are accurate for the local subtypes. The present study was designed to evaluate viral load measurements using the newer version of the NASBA assay in subtype C-infected patients. The performances of this new version, a real-time nucleic acid sequence-based amplification HIV-1 assay (NucliSens EasyQ), were compared to Amplicor HIV-1 Monitor Assay version 1.5 in 79 samples of subtype C-infected patients originating from Ethiopia. Twenty HIV-1 subtype B-infected patients served as a control group. Blood samples from patients in both groups were tested by both assays. The results were compared by a paired, two-tailed Student's t-test. The disparity between the results of the two viral load assays was highly significant in subtype C samples (P = 0.005), such that in the vast majority, higher values of viral load were obtained by the Amplicor assay. However, no differences between the two assays were found in subtype B samples (P = 0.77). CD4 measurements were available for 78 samples of subtype C-infected patients. Of these, a CD4-to-viral load discrepancy (CD4 <or= 200, viral load <or=5,000 IU/ml) was found in 11.5% of the samples when using the EasyQ assay, compared with 5.1% of the samples using the Amplicor assay. In conclusion, the performance of the NucliSens EasyQ assay was inferior to that of the Amplicor assay in assessing viral load levels in subtype C-infected patients. This difference may have a significant bearing on patient care.
在应对发展中国家治疗艾滋病毒感染患者的全球项目时，确实需要针对当地亚型准确的病毒载量检测方法。本研究旨在评估在C亚型感染患者中使用更新版本的核酸序列扩增技术（NASBA）检测病毒载量的情况。将这种新版本的实时基于核酸序列的扩增HIV-1检测方法（NucliSens EasyQ）与Amplicor HIV-1 Monitor检测方法1.5版，在79份源自埃塞俄比亚的C亚型感染患者样本中进行性能比较。20名HIV-1 B亚型感染患者作为对照组。两组患者的血样均用这两种检测方法进行检测。结果通过配对双尾学生t检验进行比较。在C亚型样本中，两种病毒载量检测结果的差异非常显著（P = 0.005），以至于在绝大多数情况下，Amplicor检测方法获得的病毒载量值更高。然而，在B亚型样本中未发现两种检测方法之间存在差异（P = 0.77）。有78份C亚型感染患者样本可进行CD4检测。其中，使用EasyQ检测方法时，11.5%的样本出现CD4与病毒载量不一致的情况（CD4≤200，病毒载量≤5000 IU/ml），而使用Amplicor检测方法时，这一比例为5.1%。总之，在评估C亚型感染患者的病毒载量水平时，NucliSens EasyQ检测方法的性能不如Amplicor检测方法。这种差异可能对患者护理有重大影响。
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