Quantitative RNA Viral Assay for Immunosuppression in Humans of Type 1 (HIV-1) - Vietnam Registration 2401197ĐKLH/BYT-HTTB

The Artus HI Virus-1 QS-RGQ Kit is an in vitro nucleic acid amplification test used to quantify the RNA of the human immunodeficiency virus type 1 (HIV-1) in the blood plasma (EDTA) of individuals. This diagnostic test uses reverse transcription polymerase chain reaction (RT-PCR) and is intended to be used on the QIAsymphony SP/AS and Rotor-gen Q devices. Samples from all subtypes A-H are used to evaluate the test. The Artus HI Virus-1 QS-RGQ Kit is used in combination with clinical manifestations and other clinical signs to predict and is used to support the evaluation of the viral response to treatment with antiretroviral therapy by measuring the change in the concentration of HIV-1 RNA in the blood plasma (EDTA) of individuals. The Artus HI Virus-1 QS-RGQ Kit is not intended to be used as an HIV screening test or as a diagnostic test for the presence of HIV.