The Sentosa SQ HIV-1 Genotyping Assay is a next generation sequencing (NGS)-based in vitro diagnostic (IVD) test intended for use in detecting HIV-1 genomicmutations (in the protease, reverse transcriptase and integrase regions of the pol gene), as an aid in monitoring and treating HIV-1 infection. This test is used in adjunct to the therapeutic management of patients diagnosed with HIV-1 Group M infection, with viral loads of at least 1,000 RNA copies per mL in EDTA plasma specimens.The Sentosa SQ HIV-1 Genotyping Assay consists of Sentosa SQ HIV-1 Genotyping Reagents and Sentosa SQ Virus Testing Solutions. They are used with the Sentosa SQ HIV-1 Positive Control Kit (96/8).
A collection of reagents and other associated materials intended to be used to determine the genotype of human immunodeficiency virus 1 (HIV1) in a clinical specimen, using a nucleic acid technique (NAT). The genotyping is typically performed to help determine viral resistance to specific antiretroviral drugs (AVRs) during patient treatment planning.