Noorbazargan Hassan, Nadji Seyed Alireza, Mirab Samiee Siamak, Paryan Mahdi, Mohammadi-Yeganeh Samira
Department of Biotechnology, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Virology Research Center (VRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Comp Immunol Microbiol Infect Dis. 2018 Aug;59:1-7. doi: 10.1016/j.cimid.2018.09.002. Epub 2018 Sep 11.
The aim of this study was to compare the analytical performance of an In-House HIV-1 viral load determination technique with three commercial kits including COBAS AmpliPrep, RealStar, and RTA HIV-1 Real-Time PCR.
A total of 100 HIV-1 suspicious plasma samples were tested by the In-House TaqMan Real-Time PCR assay along with the above-mentioned kits. Comparative analysis between In-House and reference method (COBAS AmpliPrep/COBAS TaqMan HIV-1 Test version 2.0) showed high concordance with a mean difference of 0.08 log copies/ml. All samples results were within -0.16-0.31 log copies/ml. A suitable correlation was obtained with a coefficient (R) of 0.82 between the In-House assay and RTA Kit, however, two positive samples were not detected. The lowest agreement was detected with RealStar HIV Kit 1.0 (R = 0.49, r = 0.7).
The newly developed method has suitable sensitivity, accuracy, and precision. In addition, it is cost-effective and can be an alternative in all laboratories.
本研究旨在比较一种内部HIV-1病毒载量测定技术与三种商业试剂盒（包括COBAS AmpliPrep、RealStar和RTA HIV-1实时荧光定量PCR试剂盒）的分析性能。
使用内部TaqMan实时荧光定量PCR检测方法以及上述试剂盒对总共100份HIV-1疑似血浆样本进行了检测。内部方法与参考方法（COBAS AmpliPrep/COBAS TaqMan HIV-1检测版本2.0）之间的比较分析显示高度一致，平均差异为0.08 log拷贝/毫升。所有样本结果均在-0.16至0.31 log拷贝/毫升范围内。内部检测方法与RTA试剂盒之间的相关系数（R）为0.82，相关性良好，然而，有两份阳性样本未被检测到。与RealStar HIV试剂盒1.0的一致性最低（R = 0.49，r = 0.7）。
新开发的方法具有合适的灵敏度、准确性和精密度。此外，它具有成本效益，可在所有实验室中作为替代方法。
