This Standard specifies the requirements, test methods, mark, label and use instructions, package, transportation, storage, etc. of the HIV-1 RNA quantitative assay. This Standard is applicable to the HIV-1 RNA reagent based on the nucleic acid amplification methods (including real-time fluorescent PCR method, NASBA method based on the nucleotide-amplification, and branched DNA, namely, bDNA method), and used for quantitatively testing the human serum and/or plasma; it is abbreviated as HIV-1 RNA quantitative assay.