Improved Performance of COBAS AmpliPrep/COBAS TaqMan Version 2.0 Assay Over Amplicor Monitor Version 1.5 in the Quantification of HIV-1 RNA Viral Load in Abuja, Nigeria
Improved Performance of COBAS AmpliPrep/COBAS TaqMan Version 2.0 Assay Over Amplicor Monitor Version 1.5 in the Quantification of HIV-1 RNA Viral Load in Abuja, Nigeria
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DOI：
10.2174/1570162x13666150121112139
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发表时间：
2015-01-01
影响因子：
1
通讯作者：
Abimiku, Alash'le G.
中科院分区：
文献类型：
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作者：
Abubakar, Ado;Ndembi, Nicaise;Abimiku, Alash'le G.
背景：不同的生产商已经报道了通过真实的时间PCR相对于手动测定的改进的病毒检测。然而，针对同一病原体的不同平台之间的差异和不一致性也被观察到在不同的setting.Methods：我们使用分析研究设计来比较Cobas Taqman /Cobas Ampliprep版本2.0与标准Amplicor Monitor 1.5的性能，使用200个常规临床样本，在阿布贾尼日利亚。Taqman和Amplicor分别检测了118/200（59%）和83/200（41.5%）样本。在Cobas Taqman检测不到的83份样品中，有2份（2.4%）可被Roche Amplicor检测到，而在Amplicor使用Taqman检测不到的37份样品中，有5份（13.5%）可被Roche Amplicor检测到。在81个可通过两种测定法检测的样品中，4个样品（4.9%）的log 10差异>0.5 log拷贝，而9个样品（11.1%）显示出>1 log 10的更大差异。Bland和Altman的比较显示两种方法之间无显著性差异（p=0.2825），CI为0.06171 ~ 0.2087。结论：COBAS AmpliPrep/COBAS TaqMan 2.0版检测HIV 1 RNA病毒载量的性能明显优于Amplicor Monitor 1.5版。还记录了两个平台之间病毒载量的临床显著性差异。程序、临床医生和制造商需要考虑自动化Taqman 2.0无法检测2.4%的Amplicor可检测样本的影响。还建议定期评估平台，以检测每个地方新的艾滋病毒亚型。
Background: Improved viral detections by the real time PCR over the manual assays have been reported by various manufacturers. However, discrepancies and discordance between different platforms targeting the same pathogen have also been observed at different settings.Methods: We used an analytical study design to compare the performance of the Cobas Taqman /Cobas Ampliprep version 2.0 against the standard Amplicor Monitor 1.5 using 200 routine clinical samples, in AbujaNigeria.Results: Taqman and Amplicor detected 118/200 (59%) and 83/200 (41.5%) samples respectively. Two of 83 samples (2.4%) undetectable by Cobas Taqman, were detectable by Roche Amplicor, while 5 of 37 samples (13.5%) which were undetectable by Amplicor using Taqman. Among the 81 detectable samples by both assays 4 samples (4.9%) had a log10 difference >0.5 log copies, while 9 samples (11.1%) showed a wider discrepancy of >1 log10. Bland and Altman's comparison shows no significant difference between the two methods (p=0.2825) and CI-0.06171 to 0.2087.Conclusion: We observed a remarkable improvement in the performance of COBAS AmpliPrep/COBAS TaqMan version 2.0 Assay over Amplicor Monitor version 1.5 in the quantification of HIV1 RNA viral load. Discrepancies of clinical significance, in the viral load between the two platforms were also recorded. The implications of the inability of the automated Taqman 2.0 to detect 2.4% of samples detectable by the Amplicor need to be considered by programs, clinicians and the manufacturers. Periodic evaluation of platforms to detect new circulating HIV subtypes within each locality is also recommended.