[A single-tube real-time RT-PCR assay for the RNA detection and quantification of genetically diverse HIV Including rare non-M group of the HIV-1 and HIV-2]

The RT-PCR method with real-time fluorescence detection was used for development of φ prototype of diagnostic kit for reliable diagnosis of genetic variants of RNA of the HIV-1 of groups M, N, O, P and RNA of the HIV-2 in blood plasma and serum. The kit is stable against nucleotide defects, provides broad linear range of concentration of the HIV RNA, 100% analytical specificity and adequate analytical sensitivity: 42 ME/ml (HIV-1 of group M), 45 copies/ml (HIV-2), 92 copies/ml (HIV-1 of group O), 90 copies/ml (HIV-1 of group N). The kit provided successful detection and measurement of HIV RNA concentration in the samples of the international reference panel of the HIV-1 genotype. The results of the test correlate with results of commercial tests.