Molecular diagnostic test kit Aptima®

geneticHIVserum

Dual-claim assay to confirm HIV-1 infection and measure viral load. HIV-1 Detection and Viral Load Monitoring With performance you can count on, the Aptima HIV-1 Quant Dx assay is a dual-claim assay that can be used to confirm HIV-1 infection and measure viral load for optimal patient management.1 It offers reliable quantitation of HIV-1 RNA across a broad linear range, giving your lab excellent precision and sensitivity for HIV-1 detection and viral load monitoring. The Aptima HIV-1 Quant Dx Assay intended use is to: Confirm HIV Infection Running on the Panther® system, Aptima HIV-1 Quant Dx accurately detects and monitors HIV-1 for reliable, repeatable results. Monitor Viral Load Industry-leading precision gives you confidence that any changes in viral load reflect clinical changes in the patient—not variations in the assay. Robust assay design to guard against mutations The Aptima HIV-1 Quant Dx assay design provides 3 levels of protection for confidence in assay performance despite drug selection pressures and growing genetic diversity:1 Dual-target approach for built-in redundancy, with both targets chosen within highly conserved genomic regions of HIV-1 (LTR and pol) to ensure accurate quantitation Sophisticated primer design to tolerate mutations Redundant oligonucleotides for consistent performance Claim Dx & Quant LoD 12 copies/mL in plasma 8.9 copies/mL in serum LLoQ 30 copies/mL Methodology RT-TM A highly sensitive assay for reliable quantitation of HIV-1 RNA. The Aptima HIV-1 Quant Dx Assay ensures detection and quantitation across major groups and subtypes (M, N, O)