Abbott HIV Test Kit - Taiwan Registration 5a0f4c9358dd601f5d456d316ecc8a59

This product is an external test reagent using reverse transcription polymerase chain reaction (RT-PCR) method and using automated Alinity m system to detect and quantify ribonucleic acid (RNA) of human immunodeficiency virus type 1 (HIV-1). This product can be combined with clinical manifestations and other laboratory markers for the clinical management of HIV-1 infected patients. This product monitors disease prognosis by measuring the basal viral load of HIV-1 RNA in plasma and the viral response to antiretroviral therapy by measuring changes in HIV-1 RNA viral load in plasma. Please note that the efficacy of the quantitative results of this product using serum samples has not been established. This product can also be used as a diagnostic test to assist in diagnosing HIV-1 infection in individuals who have repeatedly tested positive for HIV immunotesting. The performance of this product for the diagnosis and interpretation of plasma and serum samples has been established. The interpretation of test results of this product is limited to all relevant clinical and laboratory findings. This product is not intended for HIV screening of blood, blood products, tissues, or organ donors.

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