Hassan Noorbazargan1, Seyed Alireza Nadji2, Siamak Mirab Samiee3, Mahdi Paryan4, Samira Mohammadi-Yeganeh5. 1. Department of Biotechnology, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 2. Virology Research Center (VRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran. 3. Food and Drug Laboratory Research Center, Tehran, Iran. 4. Department of Research and Development, Production and Research Complex, Pasteur Institute of Iran, Tehran, Iran. Electronic address: m_paryan@pasteur.ac.ir. 5. Cellular and Molecular Biology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Biotechnology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: s.mohammadiyeganeh@sbmu.ac.ir.
Abstract
OBJECTIVES: 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. RESULTS: 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 log10 copies/ml. All samples results were within -0.16-0.31 log10 copies/ml. A suitable correlation was obtained with a coefficient (R2) 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 (R2 = 0.49, r = 0.7). CONCLUSIONS: The newly developed method has suitable sensitivity, accuracy, and precision. In addition, it is cost-effective and can be an alternative in all laboratories.
OBJECTIVES: 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. RESULTS: 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 log10 copies/ml. All samples results were within -0.16-0.31 log10 copies/ml. A suitable correlation was obtained with a coefficient (R2) 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 (R2 = 0.49, r = 0.7). CONCLUSIONS: The newly developed method has suitable sensitivity, accuracy, and precision. In addition, it is cost-effective and can be an alternative in all laboratories.