Automated HIV-1 assay
The Aptima HIV-1 Quant Dx assay has now been introduced on the Panther system, allowing complete sample-to-result automation in the only in vitro nucleic acid amplification test (NAAT) for both the detection and quantitation of HIV-1 RNA. The Aptima HIV-1 Quant Dx assay is intended for use as an aid in both the diagnosis and confirmation of HIV-1 infection as well as in the clinical management of patients infected with HIV-1. This highly sensitive assay can detect HIV-1 RNA as low as 13 copies/mL using a 0.5 mL sample. The Aptima HIV-1 Quant Dx assay offers the advantage of having a limit of detection (LOD) that is not equal to the lower limit of quantitation (LLOQ) when utilized for diagnosis, to enable the assay to detect HIV-1 viral load below quantifiable levels. The assay’s broad dynamic range allows quantification of HIV-1 RNA, from 30 copies/mL to 10 million copies/mL. High precision in quantitation is ensured, with a narrow coefficient of variation across the linear range—including in low-viremia samples. The Aptima HIV-1 Quant Dx assay provides 3 levels of protection for confidence in assay performance despite drug selection pressures and growing genetic diversity. This is achieved by the use of a dual-target approach for built-in redundancy, with both targets chosen within highly conserved genomic regions (LTR and pol) of HIV-1 together with a sophisticated primer design – including length – to tolerate mutations; as well as redundant oligonucleotides for additional protection against mutations. The random access Panther system eliminates batching restrictions and allows the user to run HIV-1 side by side with 3 other sexually transmitted disease/sexually transmitted infection (STD/STI) testing assays: CT/NG, HPV and Trichomonas. Primary tubes can be loaded and processed directly with no aliquot or manual transfer to a second tube required.
