Abstract

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 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). The newly developed method has suitable sensitivity, accuracy, and precision. In addition, it is cost-effective and can be an alternative in all laboratories.

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